International Pediatric MS Study Group Clinical Trials Summit Impact of a home-based activity and dietary intervention in people with slowly progressive neuromuscular diseases. Feasibility study design and methods for Project GEMS: Guidelines for Exercise in Multiple Sclerosis. Patient-orientated longitudinal study of multiple sclerosis in south west England (The South West Impact of Multiple Sclerosis Project, SWIMS) 1: protocol and baseline characteristics of cohort Development and evaluation of two web-based interventions for the promotion of physical activity in older adults: study protocol for a community-based controlled intervention trial Internet-delivered lifestyle physical activity intervention improves body composition in multiple sclerosis: preliminary evidence from a randomized controlled trial. Feasibility of an Internet Physical Activity Intervention Participant recruitment into a randomised controlled trial of exercise therapy for people with multiple sclerosis PRomotion Of Physical activity through structured Education with differing Levels of ongoing Support for people at high risk of type 2 diabetes (PROPELS): study protocol for a randomized controlled trial Randomized controlled trial of a behavioral intervention targeting symptoms and physical activity in multiple sclerosis Computer-assisted rehabilitation of attention in patients with multiple sclerosis: results of a randomized, double-blind trial A Text-Messaging and Pedometer Program to Promote Physical Activity in People at High Risk of Type 2 Diabetes: The Development of the PROPELS Follow-On Support Program A rationale and method for high-intensity progressive resistance training with children and adolescents. Reliability of Physical-Activity Measures Over Six Months in Adults with Multiple Sclerosis: Implications for Designing Behavioral Interventions Randomized controlled trial of a teleconference fatigue management plus physical activity intervention in adults with multiple sclerosis: rationale and research protocol A family-centered lifestyle intervention to improve body composition and bone mass in overweight and obese children 6 through 8 years: a randomized controlled trial study protocol PATHway I: design and rationale for the investigation of the feasibility, clinical effectiveness and cost-effectiveness of a technology-enabled cardiac rehabilitation platform
Objective : Pediatric studies for new biological agents are m and ated by recent legislation , necessitating careful thought to evaluation of emerging multiple sclerosis ( MS ) therapies in children with MS . Challenges include a small patient population , the lack of prior r and omized clinical trials , and ethical concerns . The goal of this meeting was to assess areas of consensus regarding clinical trial design and outcome measures among academic experts involved in pediatric MS care and research . Methods : The Steering Committee of the International Pediatric MS Study Group identified key focus areas for discussion . A total of 69 meeting attendees were assembled , including 35 academic experts . Regulatory and pharmaceutical representatives also attended , and provided input , which informed academic expert consensus decisions . Results : The academic experts agreed that clinical trials were necessary in pediatric MS to obtain pharmacokinetic , safety and efficacy data , and regulatory approval allowing for greater medication access . The academic experts agreed that relapse was an appropriate primary outcome measure for phase III pediatric trials . An international st and ardized cognitive battery was identified . The pros and cons of various trial design s were discussed . Guidelines surrounding MRI studies , pharmacokinetics , pharmacodynamics , and registries were developed . The academic experts agreed that given the limited subject pool , a stepwise approach to the launch of clinical trials for the most promising medications is necessary in order to ensure study completion . Alternative approaches could result in unethical exposure of patients to trial conditions without gaining knowledge . Conclusion : Consensus points for conduct of clinical trials in the rare disease pediatric MS were identified amongst a panel of academic experts , informed by regulatory and industry stakeholders OBJECTIVE To determine whether a home-based activity and dietary intervention can increase activity level , reduce caloric intake , and impact positively components of metabolic syndrome  in a disabled population . DESIGN Testing occurred at 3 points during the 6-month intervention period ( baseline , 3mo , 6mo ) and at 6 months postintervention . Each test point included laboratory testing of anthropometric and metabolic variables and 3 days of home-based activity and dietary monitoring . A personally tailored activity and dietary prescription based on baseline testing was implemented during the 6-month intervention period . SETTING Human performance laboratory of a university and each subject 's home . PARTICIPANTS Twenty adult volunteer ambulatory subjects with several types of slowly progressive neuromuscular disease ( NMD ) . INTERVENTION Using a pedometer , subjects were instructed to increase number of steps by 25 % over their baseline determined from home monitoring . An individualized dietary prescription was provided focusing on problematic issues identified from the baseline dietary profile . MAIN OUTCOME MEASURES Body composition , physical activity , dietary intake , energy expenditure , gait efficiency , metabolic variables , and quality of life . RESULTS At the end of the protocol , mean step count increased approximately 27 % above baseline ( P=.001 ) and caloric intake decreased over 300kcal/d ( P=.002 ) . Body fat percentage significantly decreased ( from 33.3%+/-1.5 % to 32.6%+/-1.6 % , P=.032 ) . Gait efficiency did not change , and metabolic variables did not show statistically significant improvement , although 2 of the 5 subjects originally meeting the criteria for metabolic syndrome at baseline no longer met the criteria at the end of the intervention period . Six months after completing the protocol , caloric intake remained significantly reduced ( P=.02 ) , but although mean step count remained elevated , it was not statistically significant . CONCLUSIONS Using a home-based protocol , people with NMD can increase activity and reduce caloric intake . Although this 6-month program showed positive changes , it was insufficient to affect risk factors associated with metabolic syndrome . It remains to be seen if a program longer than 6 months or a more rigorous program could lead to a reduction in the risk factors associated with metabolic syndrome The Guidelines for Exercise in Multiple Sclerosis ( GEMS ) program is a r and omized controlled trial ( RCT ) examining the feasibility and efficacy of a home-based exercise training program based on recent physical activity guidelines and principles of behavior change for improving symptoms and health-related quality of life ( HRQOL ) in adults with multiple sclerosis ( MS ) . The primary aim is to assess program feasibility in the four domains of process ( e.g. , recruitment , retention , and adherence ) , re sources ( e.g. , communication , staff requirements , and monetary costs ) , management ( e.g. , time and accuracy in data collection /entry , and reporting of adverse events ) and scientific outcomes ( e.g. , safety , burden , participant feedback and efficacy/ outcomes ) . The trial will recruit individuals with mild-to-moderate MS-related disability across the United States who will be r and omized into intervention or waitlist control conditions . All participants will complete home-based assessment s ( including wearing an accelerometer for 7 days and completion of a question naire booklet ) prior to and upon completion of the 4-month program . Participants in the intervention will receive a 4-month home-based exercise program emphasizing aerobic and resistance training . Participants will be provided with exercise equipment , a DVD , a manual and a log-book . The exercise program will be supplemented with periodic newsletters in the mail highlighting principles of behavior change , and video-chats with an exercise specialist to provide motivation and social accountability . This trial serves to inform development of Phase II and III RCTs which can determine the actual efficacy and effectiveness of home-based exercise based on the MS-specific physical activity guidelines for improving symptoms and HRQOL Background There is a need for greater underst and ing of the impact of multiple sclerosis ( MS ) from the perspective of individuals with the condition . The South West Impact of MS Project ( SWIMS ) has been design ed to improve underst and ing of disease impact using a patient-centred approach . The purpose is to ( 1 ) develop improved measurement instruments for clinical trials , ( 2 ) evaluate longitudinal performance of a variety of patient-reported outcome measures , ( 3 ) develop prognostic predictors for use in individualising drug treatment for patients , particularly early on in the disease course . Methods This is a patient-centred , prospect i ve , longitudinal study of multiple sclerosis and clinical ly isolated syndrome ( CIS ) in south west Engl and . The study area comprises two counties with a population of approximately 1.7 million and an estimated 1,800 cases of MS .  Self-completion question naires are administered to participants every six months ( for people with MS ) or 12 months ( CIS ) . Here we present descriptive statistics of the baseline data provided by 967 participants with MS . Results Seventy-five percent of those approached consented to participate . The male : female ratio was 1.00:3.01 ( n = 967 ) . Average ( st and ard deviation ) age at time of entry to SWIMS was 51.6 ( 11.5 ) years ( n = 961 ) and median ( interquartile range )  time since first symptom was 13.3 ( 6.8 to 24.5 ) years ( n = 934 ) . Fatigue was the most commonly reported symptom , with 80 % of participants experiencing fatigue at baseline . Although medication use for symptom control was common , there was little evidence of effectiveness , particularly for fatigue . Nineteen percent of participants were unable to classify their subtype of MS . When patient-reported subtype was compared to neurologist assessment for a sample of participants ( n = 396 ) , agreement in disease sub-type was achieved in 63 % of cases . There were 836 relapses , reported by 931 participants , in the twelve months prior to baseline . Twenty-three percent of the relapsing-remitting group and 12 % of the total sample were receiving disease-modifying therapy at baseline . Conclusions Demographics of this sample were similar to published data for the UK . Overall , the results broadly reflect clinical experience in confirming high symptom prevalence , with relatively little complete symptom relief . Participants often had difficulty in defining MS relapses and their own MS type Background Regular physical activity ( PA ) is a key contributor to healthy ageing . However , despite known health benefits , only one third of older adults in Germany reach the PA levels recommended for persons aged 65 years and above by the World Health Organization . The aim of the current study is to evaluate the effectiveness of two web-based interventions for the initiation and maintenance of regular PA ( i.e. , intervention groups 1 and 2 ) compared to a delayed intervention control group of older adults aged 65 to 75 years . Methods / Design Study participants will be r and omly assigned to one of three study arms in five communities in the Bremen-Oldenburg metropolitan region : a ) Participants in the first arm will receive access to a web-based intervention for 10 weeks allowing them to track their weekly PA ( subjective self-monitoring , intervention group 1 ) ; b ) participants in the second arm will receive access to the web-based intervention for 10 weeks and , in addition , track PA using Fitbit Zips ( objective self-monitoring , intervention group 2 ) ; c ) participants in the delayed intervention control group will receive access to the intervention implemented in the first study arm after completion of the 12-week follow-up in the other two groups within each community . In addition , weekly group meetings in the communities will be offered to study participants in the intervention groups providing the opportunity to address questions related to the use of the website and to practice PA in groups ( e.g. , neighborhood walks , strength and balance exercises ) . To evaluate short-term effects of the intervention on physical and psychological health , PA , physical fitness , and cognitive and psychological variables will be assessed at baseline and 12-week follow-up . Discussion This study will provide answers regarding acceptance and effectiveness of web-based interventions promoting uptake and maintenance of regular PA in persons aged 65–75 years . Study findings will contribute to a growing body of evidence in Germany concerning the role of community-based interventions for the promotion of PA and healthy ageing in older adults . Trial registration German Clinical Trials Register DRKS00010052 ( Date of registration 07–11 - 2016 ) OBJECTIVE To examine the efficacy of a physical activity behavioral intervention for improving outcomes of body composition in persons with multiple sclerosis ( MS ) . DESIGN Secondary analysis of data from a r and omized controlled trial . SETTING University research laboratory . PARTICIPANTS Ambulatory persons with MS ( N=82 ) . INTERVENTION A 6-month , internet-delivered physical activity behavioral intervention design ed to increase lifestyle physical activity , primarily walking . The behavioral intervention was based on principles of social cognitive theory . MAIN OUTCOME MEASURES Whole-body bone mineral content ( BMC ) , bone mineral density ( BMD ) , and soft tissue composition , using dual-energy x-ray absorptiometry . RESULTS There were no significant differences between conditions posttrial on body composition outcomes using the adjusted critical value ( P<.008 ) . There was a significant effect of the intervention on whole-body BMC ( P=.04 , ω(2)<.001 ) and BMD ( P=.01 , ω(2)=.003 ) using the unadjusted critical value ( P<.05 ) . The effect of the intervention on percent body fat ( P=.09 , ω(2)=.001 ) and whole-body fat mass ( P=.05 , ω(2)=.003 ) approached significance using unadjusted criteria . There was not a significant effect on whole-body lean soft tissue ( P=.28 , ω(2)<.001 ) or body mass index ( P=.86 , ω(2)<.001 ) . CONCLUSIONS Our results provide preliminary evidence that an internet-delivered lifestyle physical activity intervention might improve bone health and body composition in MS . Such findings are important considering that physical activity is a modifiable behavior with the potential to confer long-term benefits for the prevention and management of fracture risk and comorbidities among those with MS The Internet is a relatively new method of delivering strategies for health behavior change . The purpose of this study was to determine the feasibility of delivering a physical activity intervention by the Internet to improve outcomes in adults with the metabolic syndrome . Twenty-two participants ( 16 males ; 6 females ) were recruited from a cardiology clinic data base , age range 32 - 66 years . Participants were r and omly assigned to the  Internet intervention  ( n = 12 ) or the  usual care  ( n = 10 ) group . The mean total dose , in terms of the time the intervention Web site was accessed was 2 hours over 6 weeks , which was greater than the time spent delivering usual care . Overall , participants ' evaluations of the Internet intervention were positive . The costs of development and delivery of the Internet intervention  were less than that of a consultation and follow-up in the cardiology clinic for this sample . The Internet intervention appears feasible for testing in a larger study Background The success of a clinical trial is often dependant on whether recruitment targets can be met in the required time frame . Despite an increase in research into the benefits of exercise in people with multiple sclerosis ( PwMS ) , no trial has reported detailed data on effective recruitment strategies for large-scale r and omised controlled trials . The main purpose of this report is to provide a detailed outline of recruitment strategies , rates and estimated costs in the Exercise Intervention for Multiple Sclerosis ( ExIMS ) trial to identify best practice s for future trials involving multiple sclerosis ( MS ) patient recruitment . Methods The ExIMS research ers recruited 120 PwMS to participate in a 12-week exercise intervention .  Participants were r and omly allocated to either  exercise or usual-care control groups . Participants were sedentary , aged 18–65 years and had Exp and ed Disability Status Scale scores of 1.0–6.5 . Recruitment strategies included attendance at MS outpatient clinics , consultant mail-out and trial awareness-raising activities . Results A total of 120 participants were recruited over the course of 34 months . To achieve this target , 369 potentially eligible and interested participants were identified . A total of 60 % of participants were recruited via MS clinics , 29.2 % from consultant mail-outs and 10.8 % through trial awareness . The r and omisation yields were 33.2 % , 31.0 % and 68.4 % for MS clinic , consultant mail-outs and trial awareness strategies , respectively . The main reason for in eligibility was being too active ( 69.2 % ) , whilst for eligible participants the most common reason for non-participation was the need to travel to the study site ( 15.8 % ) . Recruitment via consultant mail-out was the most cost-effective strategy , with MS clinics being the most time-consuming and most costly . Conclusions To reach recruitment targets in a timely fashion , a variety of methods were employed . Although consultant mail-outs were the most cost-effective recruitment strategy , use of this method alone would not have allowed us to obtain the predetermined number of participants in the required time period , thus leading to costly extensions of the project or failure to reach the number of participants required for sufficient statistical power . Thus , a multifaceted approach to recruitment is recommended for future trials . Trial registration International St and ard R and omised Controlled Trial Registry number : IS RCT N41541516 ; date registered : 5 February 2009 Background The prevention of type 2 diabetes is recognised as a health care priority . Lifestyle change has proven effective at reducing the risk of type 2 diabetes , but limitations in the current evidence have been identified in : the promotion of physical activity ; availability of interventions that are suitable for commissioning and implementation ; availability of evidence -based interventions using new technologies ; and physical activity promotion among ethnic minorities . We aim to investigate whether a structured education programme with differing levels of ongoing support , including text-messaging , can increase physical activity over a 4 year period in a multi-ethnic population at high risk of diabetes . Methods / Design A multi-centre r and omised controlled trial , with follow-up at 12 and 48 months . The primary outcome is change in ambulatory activity at 48 months . Secondary outcomes include changes to markers of metabolic , cardiovascular , anthropometric and psychological health along with cost-effectiveness .  Participants aged 40–74 years for White European , or 25–74 years for South Asians , with an HbA1c value of between 6.0 and < 6.4 % ( 42 and 47 mmol/mol ) or with a previously recorded plasma glucose level or HbA1c value within the high risk ( prediabetes ) range within the last five years , are invited to take part in the trial . Participants are identified through primary care , using an automated diabetes risk score within their practice data base , or from a data base of previous research participants . Participants are r and omly assigned to either : 1 ) the control group who receive a detailed advice leaflet ; 2 ) the Walking Away group , who receive the same leaflet and attend a 3 hour structured education programme with annual maintenance sessions delivered in groups ; or 3 ) the Walking Away Plus group , who receive the leaflet , attend the structured education programme with annual maintenance sessions , plus receive follow-on support through highly-tailored text-messaging and telephone calls to help to aid pedometer use and behaviour change . Discussion This study will provide new evidence for the long-term effectiveness of a structured education programme focused on physical activity , conducted within routine care in a multi-ethnic population in the UK . It will also investigate the impact of different levels of ongoing support and the cost-effectiveness of each intervention . Trial registration IS RCT N83465245 Trial registration date : Background : Exercise training is beneficial , but most persons with multiple sclerosis ( MS ) are sedentary and physically inactive . This has prompted a new focus on the promotion of lifestyle physical activity in MS . We previously design ed , tested , and refined a behavioral intervention delivered through the Internet that successfully increased lifestyle physical activity in MS , but have not evaluated the effects on secondary symptomatic and health-related quality of life ( HRQOL ) outcomes . Objective : We conducted a 6-month r and omized controlled trial ( RCT ) that examined the efficacy of an Internet-delivered , behavioral intervention for improving outcomes of fatigue , depression , anxiety , pain , sleep quality , and HRQOL in 82 ambulatory persons with MS . The secondary aim was to replicate previous results regarding change in free-living physical activity . Results : There was a significant and positive effect of the intervention on fatigue severity ( p=.001 , ηρ2=.15 ) and its physical impact ( p=.008 , ηρ2=.09 ) , depression ( p=.006 , ηρ2=.10 ) , and anxiety ( p=.006 , ηρ2=.10 ) . There were non-significant improvements in pain ( p=.08 , ηρ2=.04 ) , sleep quality ( p=.06 , ηρ2=.05 ) , and physical HRQOL ( p=.06 , ηρ2=.05 ) . We replicated our previous results by demonstrating an increase in self-reported physical activity ( p=.001 , ηρ2=.13 ) . Conclusions : Our results support behavioral interventions targeting lifestyle physical activity as an alternative approach for managing symptoms in MS Background : There is controversial information on the efficacy of cognitive rehabilitation in multiple sclerosis ( MS ) . Objective : The objective of this paper is to test a home-based computerized program for retraining attention dysfunction in MS . Methods : Relapsing – remitting patients who failed > 2 tests of attention on an extensive neuropsychological battery were r and omized to  specific or nonspecific computerized training ( ST , n-ST )  , in one-hour sessions , twice a week for three months . Outcome measures included neuropsychological assessment , depression , fatigue , everyday activities and a visual analogue scale assessing attentive performance ( VAS ) . Assessment s were repeated after the interventions and after a further three months . Statistical analysis included the analysis of variance ( ANOVA ) for repeated measures . Results : Eighty-eight out of 102 r and omized patients completed the study ( 69 women , age 40.9 ± 11.5 years , disease duration 13.0 ± 8.7 years , Exp and ed Disability Status Scale score 2.7 ± 1.5 ) . Fifty-five patients were r and omized to ST , 33 to n-ST . A benefit of the ST was observed on the Paced Auditory Serial Addition Test ( p < 0.002 ) . However , patient self-report did not reveal differences between ST and n-ST patient groups . Conclusion : Although our program trained different attention components , we could detect some improvements exclusively on tasks of sustained attention . Moreover , patient self-perceived results may be independent of the training program Background Mobile technologies for health ( mHealth ) represent a promising strategy for reducing  type 2 diabetes ( T2DM ) risk  . The PROPELS trial investigates whether structured group-based education alone or supplemented with a follow-on support program combining self-monitoring with pedometers and tailored text-messaging is effective in promoting and maintaining physical activity among people at high risk of T2DM . Objective This paper describes the iterative development of the PROPELS follow-on support program and presents evidence on its acceptability and feasibility . Methods We used a modified mHealth development framework with four phases : ( 1 ) conceptualization of the follow-on support program using theory and evidence , ( 2 ) formative research including focus groups ( n=15 , ages 39 - 79 years ) , ( 3 ) pre-testing focus groups using a think aloud protocol  ( n=20 , ages 52 - 78 years ) , and ( 4 ) piloting ( n=11 ) . Analysis was informed by the constant comparative approach , with findings from each phase informing subsequent phases . Results The first three phases informed the structure , nature , and content of the follow-on support program , including the frequency of text messages , the need for tailored content and two-way interaction , the importance of motivational messages based on encouragement and reinforcement of affective benefits ( eg , enjoyment ) with minimal messages about weight and T2DM risk , and the need for appropriate language . The refined program is personalized and tailored to the individual ’s perceived confidence , previous activity levels , and physical activity goals . The pilot phase indicated that the program appeared to fit well with everyday routines and was easy to use by older adults . Conclusions We developed a feasible and innovative text messaging and pedometer program based on evidence and behavior change theory and grounded in the experiences , views , and needs of people at high diabetes risk . A large scale trial is testing the effectiveness of this 4-year program over and above structured group education alone . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 83465245 ; http://www.controlled-trials.com/IS RCT N83465245/83465245 ( Archived by WebCite at http://www.webcitation.org/6dfSmrVAe BACKGROUND The rising prevalence of obesity in children and adolescents is implicated in the metabolic abnormalities that track into adulthood . The associated increased incidence of insulin resistance , metabolic syndrome and type 2 diabetes being identified in younger cohorts has given rise to a critical global health issue . Muscular strength is a vital component of metabolic fitness that provides protection from insulin resistance in adults , and we have recently shown this to be true in children as well . Targeting muscular strength deficiencies at an early age may be an effective preventative strategy for metabolic syndrome and type 2 diabetes . PURPOSE There is limited evidence -based best practice for progressive resistance training ( PRT ) , adiposity and metabolic fitness in children and adolescents . The purpose of this paper is to describe the methodology we utilized for implementing a PRT program to avoid publication bias , enable replication of the study and share a novel program that we have found safe and suitable for use with youth . METHODS We conducted the first r and omized controlled trial ( RCT ) prescribing high-intensity PRT to children and adolescents ( 10 - 15 years ) as a community-based primary prevention program to address adiposity and metabolic health . Participants were instructed to complete 2 sets of 8 repetitions of 11 exercises targeting all the major muscle groups twice a week at an RPE of 15 - 18 for 8 weeks . RESULTS Primary outcome was waist circumference ; secondary outcomes included insulin resistance , lipid levels , muscle strength , cardiorespiratory fitness , body composition , self-efficacy , self-concept , habitual physical activity , nutritional and sedentary behavior patterns . CONCLUSION The supervised PRT program that we used with children and adolescents has been described in detail . The efficacy of this modality of exercise for metabolic fitness and other health outcomes is now under investigation Reliability estimates are important parameters for power analyses and sample -size calculations in behavioral interventions for increasing physical activity among persons with multiple sclerosis ( MS ) . This study involved a secondary data analysis for providing reliability estimates for measures of physical activity over a six-month period in MS . On two occasions separated by six months , participants completed the Godin Leisure-Time Exercise Question naire ( GLTEQ ) and wore an ActiGraph model 7164 accelerometer on a belt around the waist for a seven-day period . The outcomes from the accelerometer were total activity counts and minutes of moderate-to-vigorous physical activity ( MVPA ) per day . The main analyses involved two-way , r and om effects intraclass correlation coefficients ( ICCs ) . The ICCs for GLTEQ scores , total activity counts , and minutes of MVPA were .66 , .84 , and .84 , respectively . Additionally , the sample was less physically active than adults without MS , and correlation analyses supported the validity of the measures , but within a substantially larger sample . Overall , the measures had acceptable , but different , reliability over six months in this sample of mostly women with relapsing – remitting MS . Power analyses using the reliability estimates indicated vastly different sample sizes for the measures of physical activity and when compared with the default parameter in software packages Background Chronic fatigue and inactivity are prevalent problems among individuals with multiple sclerosis ( MS ) and may independently or interactively have detrimental effects on quality of life and ability to participate in life roles . However , no studies to date have systematic ally evaluated the benefits of an intervention for both managing fatigue and promoting physical activity in individuals with MS . This study involves a r and omized controlled trial to examine the effectiveness of a telehealth intervention that supports individuals with MS in managing fatigue and increasing physical activity levels . Methods / Design A r and omly-allocated , three-parallel group , time-series design with a social support program serving as the control group will be used to accomplish the purpose of the study . Our goal is to recruit 189 ambulatory individuals with MS who will be r and omized into one of three  telehealth interventions : ( 1 ) a contact-control social support intervention , ( 2 ) a physical activity-only intervention , and ( 3 ) a physical activity plus fatigue management intervention . All interventions will last 12 weeks and will be delivered entirely over the phone . Our hypothesis is that , in comparison to the contact-control condition , both the physical activity-only intervention and the physical activity plus fatigue management intervention will yield significant increases in physical activity levels as well as improve fatigue and health and function , with the physical activity plus fatigue management intervention yielding significantly larger improvements . To test this hypothesis , outcome measures will be administered at Weeks 1 , 12 , and 24 . Primary outcomes will be the Fatigue Impact Scale , the Godin Leisure-Time Exercise Question naire ( GLTEQ ) , and Actigraph accelerometers . Secondary outcomes will include the SF-12 Survey , Mental Health Inventory , Multiple Sclerosis Impact Scale , the Community Participation Indicator , and psychosocial constructs ( e.g. , self-efficacy ) . Discussion The proposed study is novel , in that it represents a multi-disciplinary effort to merge two promising lines of research on MS : fatigue management and physical activity promotion . Collectively , the proposed study will be the largest r and omized controlled trial to examine the effects of a lifestyle physical activity intervention in people with MS.Trial registration Background Childhood obesity gives rise to health complications including impaired musculoskeletal development that associates with increased risk of fractures . Prevention and treatment programs should focus on nutrition education , increasing physical activity ( PA ) , reducing sedentary behaviours , and should monitor bone mass as a component of body composition . To ensure lifestyle changes are sustained in the home environment , programs need to be family-centered . To date , no study has reported on a family-centered lifestyle intervention for obese children that aims to not only ameliorate adiposity , but also support increases in bone and lean muscle mass . Furthermore , it is unknown if programs of such nature can also favorably change eating and activity behaviors . The aim of this study is to determine the effects of a 1 y family-centered lifestyle intervention , focused on both nutrient dense foods including increased intakes of milk and alternatives , plus total and weight-bearing PA , on body composition and bone mass in overweight or obese children . Methods / design The study design is a r and omized controlled trial for overweight or obese children ( 6–8 y ) . Participants are r and omized to control , st and ard treatment ( StTx ) or modified treatment ( ModTx ) . This study is family-centred and includes individualized counselling sessions on nutrition , PA and sedentary behaviors occurring 4 weeks after baseline for 5 months , then at the end of month 8 . The  control group receives counselling at the end of the study . All groups are measured at baseline and every 3 months for the primary outcome of changes in body mass index Z-scores . At each visit blood is drawn and children complete a research er-administered behavior question naire and muscle function testing . Changes from baseline to 12 months in body fat ( % and mass ) , waist circumference , lean body mass , bone ( mineral content , mineral density , size and volumetric density ) , dietary intake , self-reported PA and sedentary behaviour are examined . Discussion This family-centered theory-based study permits for biochemical and physiological assessment s. This trial will assess the effectiveness of the intervention at changing lifestyle behaviours by decreasing adiposity while enhancing lean and bone mass . If successful , the intervention proposed offers new insights for the management or treatment of childhood obesity . Trial registration Clinical Trials.gov , NCT01290016 Introduction Exercise-based cardiac rehabilitation ( CR ) independently alters the clinical course of cardiovascular diseases result ing in a significant reduction in all-cause and cardiac mortality . However , only 15%–30 % of all eligible patients participate in a phase 2 ambulatory programme . The uptake rate of community-based programmes following phase 2 CR and adherence to long-term exercise is extremely poor . Newer care models , involving telerehabilitation programmes that are delivered remotely , show considerable promise for increasing adherence . In this view , the PATHway ( Physical Activity Towards Health ) platform was developed and now needs to be evaluated in terms of its feasibility and clinical efficacy . Methods and analysis In a multicentre r and omised controlled pilot trial , 120 participants ( m/f , age 40–80 years ) completing a phase 2 ambulatory CR programme  will be r and omised on a 1:1 basis to PATHway or usual care . PATHway involves a comprehensive , internet-enabled , sensor-based home CR platform and provides individualised heart rate monitored exercise programmes ( exerclasses and exergames ) as the basis on which to provide a personalised lifestyle intervention programme . The control group will receive usual care . Study outcomes will be assessed at baseline , 3 months and 6 months after completion of phase 2 of the CR programme . The primary outcome is the change in active energy expenditure . Secondary outcomes include cardiopulmonary endurance capacity , muscle strength , body composition , cardiovascular risk factors , peripheral endothelial vascular function , patient satisfaction , health-related quality of life ( HRQoL ) , well-being , mediators of behaviour change and safety . HRQoL and healthcare costs will be taken into account in cost-effectiveness evaluation . Ethics and dissemination The study will be conducted in accordance with the Declaration of Helsinki . This protocol has been approved by the director and clinical director of the PATHway study and by the ethical committee of each participating site . Results will be disseminated via peer- review ed scientific journals and presentations at congresses and events . Trial registration number NCT02717806 . This trial is currently in the pre- results stage
4 ) Conclusions : The analysis of the information here reported sheds light for the design of future clinical trials in adults with MS .
The best anthropometric parameters and units of measurement to monitor the interventions are related to dietary and physical exercise interventions .
( 1 ) Objective : to establish practical guidance for the design of future clinical trials in MS ( metabolic syndrome ) patients aged 18 and older , based on a systematic review of r and omized clinical trials connecting diet , physical exercise and changes in body composition . (