Efficacy of Quantified Home-Based Exercise and Supervised Exercise in Patients With Intermittent Claudication: A Randomized Controlled Trial Randomized clinical trial comparing Nordic pole walking and a standard home exercise programme in patients with intermittent claudication Supervised exercise therapy for intermittent claudication in a community-based setting is as effective as clinic-based. Long-term effects of structured home-based exercise program on functional capacity and quality of life in patients with intermittent claudication. Treatment efficacy of intermittent claudication by surgical intervention, supervised physical exercise training compared to no treatment in unselected randomised patients I: one year results of functional and physiological improvements. Local Versus Systemic Mechanisms Underlying Supervised Exercise Training for Intermittent Claudication The vascular nurse in practice: Results of prescribed exercise training in patients with intermittent claudication. Improvement of the walking ability in intermittent claudication due to superficial femoral artery occlusion with supervised exercise and pneumatic foot and calf compression: a randomised controlled trial. Influence of upper- and lower-limb exercise training on cardiovascular function and walking distances in patients with intermittent claudication. Impact of exercise training on inflammation and platelet activation in patients with intermittent claudication. Long‐term clinical effectiveness of supervised exercise therapy versus endovascular revascularization for intermittent claudication from a randomized clinical trial Effects of home versus supervised exercise for patients with intermittent claudication. The effect of exercise intensity on the response to exercise rehabilitation in patients with intermittent claudication. Quality of life improvement after hospital- based rehabilitation or home-based physical training in intermittent claudication. The Claudication: Exercise Vs. Endoluminal Revascularization (CLEVER) study: rationale and methods. Design of the multicenter standardized supervised exercise training intervention for the ‘CLaudication: Exercise Vs Endoluminal Revascularization (CLEVER) study’ Upper- versus lower-limb aerobic exercise training on health-related quality of life in patients with symptomatic peripheral arterial disease.
Background — This prospect i ve , r and omized , controlled clinical trial compared changes in exercise performance and daily ambulatory activity in peripheral artery disease patients with intermittent claudication after a home-based exercise program , a supervised exercise program , and usual-care control . Methods and Results — Of the 119 patients r and omized , 29 completed home-based exercise  , 33 completed  supervised exercise , and 30 completed usual-care control . Both exercise programs consisted of intermittent walking to nearly maximal claudication pain for 12 weeks . Patients wore a step activity monitor during each exercise session . Primary outcome measures included claudication onset time and peak walking time obtained from a treadmill exercise test ; secondary outcome measures included daily ambulatory cadences measured during a 7-day monitoring period . Adherence to home-based and supervised exercise was similar ( P=0.712 ) and exceeded 80 % . Both exercise programs increased claudication onset time ( P<0.001 ) and peak walking time ( P<0.01 ) , whereas only home-based exercise increased daily average cadence ( P<0.01 ) . No changes were seen in the control group ( P>0.05 ) . The changes in claudication onset time and peak walking time were similar between the 2 exercise groups ( P>0.05 ) , whereas the change in daily average cadence was greater with home-based exercise ( P<0.05 ) . Conclusions — A home-based exercise program , quantified with a step activity monitor , has high adherence and is efficacious in improving claudication measures similar to a st and ard supervised exercise program . Furthermore , home-based exercise appears more efficacious in increasing daily ambulatory activity in the community setting than supervised exercise . Clinical Trial Registration — URL : http://www . Clinical Trials . Gov . Unique identifier : NCT00618670 This was a r and omized clinical trial to determine whether Nordic pole walking ( NPW ) is more effective in improving walking distance than a st and ard home exercise programme ( HEP ) in patients with intermittent claudication OBJECTIVE This cohort study was conducted to determine the effect on walking distances of supervised exercise therapy provided in a community-based setting . METHODS The study included all consecutive patients presenting at the vascular outpatient clinic with intermittent claudication , diagnosed by a resting ankle brachial index<0.9 , who had no previous peripheral vascular intervention for peripheral arterial disease , no major amputation , and sufficient comm and of the Dutch language . The exclusion criterion was the inability to walk the baseline treadmill test for a minimum of 10 m. The intervention was a supervised exercise therapy in a community-based setting . A progressive treadmill test at baseline and at 1 , 3 , and 6 months of follow-up measured initial claudication distance and absolute claudication distance . Changes were calculated using the mean percentages of change . RESULTS From January through October 2005 , 93 consecutive patients with claudication were eligible . Overall , 37 patients discontinued the supervised exercise therapy program . Eleven stopped because of intercurrent diseases , whereas for 10 , supervised exercise therapy did not lead to adequate improvement and they underwent a vascular intervention . Three patients quit the program , stating that they were satisfied with the regained walking distance and did not require further supervised exercise therapy . Ten patients were not motivated sufficiently to continue the program , and in three patients , a lack of adequate insurance coverage was the reason for dropping out . Data for 56 patients were used and showed a mean percentage increase in initial claudication distance of 187 % after 3 months and 240 % after 6 months . The mean percentage of the absolute claudication distance increased 142 % after 3 months and 191 % after 6 months . CONCLUSION Supervised exercise therapy in a community-based setting is a promising approach to providing conservative treatment for patients with intermittent claudication OBJECTIVES To evaluate effects of a structured home-based exercise program on functional capacity and quality of life ( QoL ) in patients with intermittent claudication ( IC ) after 1-year follow-up , and to compare these results with those from a concurrent control group who received supervised exercise training ( SET ) . DESIGN Comparative longitudinal cohort study . SETTING Referral center . PARTICIPANTS Patients ( N=142 ) with IC . INTERVENTIONS Structured home-based exercise training or SET . MAIN OUTCOME MEASURES The maximum ( pain-free ) walking distance and the ankle-brachial index ( ABI ) ( at rest and postexercise ) were measured at baseline and after 6 and 12 months ' follow-up . Additionally , QoL was evaluated using a self-administered question naire consisting of the Euroqol-5D ( scale 0 - 1 ) , rating scale ( scale 0 - 100 ) , Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36 ; scale 0 - 100 ) , and the Vascular Quality of Life Question naire ( VascuQol ; scale 1 - 7 ) . Comparison of the groups was performed with adjustment for the nonr and omized setting using propensity scoring . RESULTS One hundred forty-two patients with IC started the  structured home-based exercise program , of whom 95 ( 67 % ) completed 12 months ' follow-up . The mean relative improvement compared with baseline was statistically significant after 12 months ' follow-up for the maximum and pain-free walking distance ( 342 % , 95 % confidence interval [ CI ] , 169 - 516 ; P<.01 and 338 % , 95 % CI , 42 - 635 ; P=.03 , respectively ) and for the ABI postexercise ( mean change , .06 ; 95 % CI , .01-.10 ; P=.02 ) . For the QoL outcomes , the improvement compared with baseline was statistically significant after 12 months for the VascuQol ( mean change , .42 ; 95 % CI , .20-.65 ; P<.01 ) and for the SF-36 physical functioning ( mean change , 5.17 ; 95 % CI , .77 - 9.56 ; P=.02 ) . Compared with the structured home-based exercise program , patients in the control group showed significantly better results in the mean relative improvement of maximum and pain-free walking distance and change in the ABI at rest after 12 months ' follow-up . CONCLUSIONS Structured home-based exercise training is effective in improving both functional capacity and QoL in patients with IC and may be considered as a feasible and valuable alternative toSET , since supervised exercise programs are not often available OBJECTIVES to compare the effect of surgery , exercise and simple observation on maximum exercise power in claudicants . DESIGN prospect i ve , r and omised study . METHODS a total of 264 unselected claudicants were r and omised to supervised exercise training , invasive treatment ( open surgical or endovascular procedures ) or observation . One year treatment outcomes were analysed on an intention to-treat basis . RESULTS invasively treated patients showed a significant improvement in maximum walking power , stopping distance , post-ischaemic blood flow and big toe pressure at one year . Patients r and omised to physical exercise training or to the control group did not improve in any outcome measure . CONCLUSION invasive treatment increased walking capacity , leg blood pressure and flow . Supervised physical exercise training offered no therapeutic advantage compared to untreated controls The mechanisms by which exercise training improves intermittent claudication remain unclear . In this article , the effects of local and systemic physiological factors on improved exercise tolerance after a supervised exercise program in claudicants are investigated . A total of 60 patients were r and omized to 3 months of supervised exercise followed by 3 months of unsupervised exercise , or to exercise advice alone ( control ) . Supervised exercise increased both pain-free and maximal walking distances . Heart rate during submaximal exercise and resting mean arterial pressure were lower after supervised exercise at 6 months . Serum lactate at maximum claudication increased significantly after 3 months in the supervised exercise group but this change had resolved by 6 months . Symptomatic improvement was accompanied by modest reductions in mean arterial pressure and submaximal heart rate on exercise . Increased serum lactate at maximum claudication subsequently declined despite continued improvement in walking distance , suggesting local adaptations to improve efficiency of muscle oxygen delivery and /or utilization Intermittent claudication ( IC ) is a mild stage of peripheral arterial disease that affects between 3 % and 7 % of the population and up to 1 in 5 patients over the age of 75 years . Risk factors such as hypertension , hyperlipidemia , diabetes , smoking , and genetics increase the incidence of peripheral arterial disease . Patients with IC have limitations in functional capacity and can benefit from regular exercise . Walking is the preferred mode of exercise and improves the symptoms of claudication in several ways . Vascular nurses can play an important role during exercise therapy . A personalized , home-based exercise program can be developed , and nurses can assist and motivate patients during follow-up periods . Helping patients to quit smoking and control other risk-factor modifications ( ie , high blood pressure and lipid levels ) also has high priority in daily practice of the vascular nurse . This prospect i ve study will illustrate the results of prescribed home-based exercise training by a vascular nurse on the maximum painless walking distance for patients with IC and will be applied to subgroups of vascular pathology OBJECTIVES To compare the effect of unsupervised exercise , supervised exercise and intermittent pneumatic foot and calf compression ( IPC ) on the claudication distance , lower limb arterial haemodynamics and quality of life of patients with intermittent claudication . METHODS Thirty-four eligible patients with stable intermittent claudication were r and omised to IPC ( n = 13 , 3h/d for 6 months ) , supervised exercise ( n = 12 , three hourly sessions/week for 6 months ) or unsupervised exercise ( n = 9 ) . In each patient , initial claudication distance ( ICD ) , absolute claudication distance ( ACD ) , resting ankle brachial pressure index ( ABPI ) , and resting hyperaemic calf arterial inflow were measured before , 6 weeks , 6 months and 1 year after r and omisation . Quality of life was assessed with the short form (SF)-36 , walking impairment ( WIQ ) and intermittent claudication question naires ( ICQ ) . RESULTS Compared with unsupervised exercise , both IPC and supervised exercise , increased ICD and ACD , up to 2.83 times . IPC  increased arterial inflow ( p < 0.05 at 6 weeks ) and ABPI .  Supervised exercise decreased arterial inflow and increased ABPI ( p < 0.05 at 6 months ) . Unsupervised exercise had no effect on arterial inflow or ABPI . IPC improved significantly the ICQ score and the speed score of the WIQ , while supervised exercise improved the WIQ claudication severity score . At 1 year clinical effectiveness of supervised exercise and IPC was largely preserved . CONCLUSIONS IPC , by augmenting leg perfusion , achieved improvement in walking distance comparable with supervised exercise . Long-term results in a larger number of patients will provide valuable information on the optimal treatment modality of intermittent claudication PURPOSE The effects of upper-limb ( arm cranking ) and lower-limb ( leg cranking ) exercise training on walking distances in patients with intermittent claudication was assessed . METHODS Sixty-seven patients ( 33 to 82 years old ) with moderate to severe intermittent claudication were recruited , and the maximum power generated during incremental upper- and lower-limb ergometry tests was determined , as were pain-free and maximum walking distances ( by using a shuttle walk test ) . Patients were r and omly assigned to an upper-limb training group ( n = 26 ) or a lower-limb training group ( n = 26 ) . An additional  untrained group ( n = 15 ) was recruited on an ad hoc basis in parallel with the main trial by using identical inclusion criteria . This group was subsequently shown to possess a similar demographic distribution to the two exercise groups . Supervised training sessions were held twice weekly for 6 weeks . RESULTS Both training programs significantly improved the maximum power generated during the incremental upper- and lower-limb ergometry tests ( P < . 001 ) , which may reflect an increase in central cardiovascular function that was independent of the training mode . More importantly , pain-free and maximum walking distances also improved in both training groups ( P < .001 ) . The improvements in the training groups were similar ; there were no changes in the untrained control group . These findings suggest that the symptomatic improvement after upper-limb exercise training may result , in part , from systemic cardiovascular effects rather than localized metabolic or hemodynamic changes . CONCLUSION Carefully prescribed upper-limb exercise training can evoke a rapid symptomatic improvement in patients with claudication , while avoiding the physical discomfort experienced when performing lower-limb weight-bearing exercise BACKGROUND Serum markers of inflammation and platelet activation are related to cardiovascular risk . Cardiovascular risk reduction is a major treatment goal in patients with peripheral arterial disease ( PAD ) . Although current guidelines recommend supervised exercise training ( SET ) for PAD patients with intermittent claudication , its contribution to risk reduction remains unclear . Aim of the present study was to assess the impact of SET on inflammation and platelet activation as surrogates for cardiovascular risk . METHODS Fifty-three patients with intermittent claudication were r and omly assigned to SET on top of best medical treatment ( BMT ) for 6 months ( SET-group ) or to BMT only ( BMT-group ) . High sensitivity C-reactive protein ( hs-CRP ) , interleukin-6 ( IL-6 ) and fibrinogen as well as soluble P-selectin ( sP-sel ) , prothrombin fragment 1 + 2 ( F1.2 ) and monocyte-platelet aggregates ( MPA ) were determined at study entry , after 3 , 6 and 12 months . RESULTS While clinical improvement , reflected by an increase of walking capacity , was observed upon SET , no lasting changes of markers of inflammation and platelet activation were found within the SET-group during the training period . Compared to the BMT-group no improvements of these markers were observed in response to training at any time point ( all p > 0.05 ) . CONCLUSION Regular SET added no further anti-inflammatory effect and had no effect on platelet activation when provided on top of BMT in PAD patients with intermittent claudication Long‐term comparisons of supervised exercise therapy ( SET ) and endovascular revascularization ( ER )  for patients with intermittent claudication are scarce . The long‐term clinical effectiveness of SET and ER  was assessed in patients from a r and omized trial PURPOSE This study was performed to test the efficacy of a supervised , hospital-based exercise program compared with a home-based exercise program involving minimal supervision , for both walking ability and quality of life measures in patients with exercise-limiting intermittent leg claudication . METHODS Twenty-one patients were assigned r and omly to 12 weeks of supervised exercise or to a home-based exercise group . After 12 weeks the participants in the supervised group transitioned to a home-based program . Both groups were then reevaluated at the end of 24 weeks . The initial claudication distance ( ICD ) and absolute claudication distance ( ACD ) on progressive treadmill exercise was measured at baseline , 12 weeks , and 24 weeks . Additionally , self-reported quality of life status was evaluated using the MOS SF-36 question naire . RESULTS Each group improved ( P < 0.01 ) ACD from baseline to 12 weeks , which was sustained at the 24-week follow-up . Both groups experienced similar long-term improvements ( P < 0.05 ) in ACD ( 521.5 + /- 253.4 meters to 741.9 + /- 365.6 meters for the supervised group , 532.2 + /- 263.5 meters to 715.0 + /- 394.4 meters in the home group , P not significant , between groups ) . The supervised group experienced a greater improvement ( P < 0.01 ) in the ICD after 12 weeks than the home group but not at 24 weeks . The on-site group also experienced significant improvements in ICD after 24 weeks ( P < 0.05 ) . Neither group manifested an improvement in self-reported physical function or mental health as assessed by the MOS SF-36 . CONCLUSION A structured exercise program was more effective in improving the ICD over a 24-week period than a less formal , home-based program . However , if patients are screened properly and receive adequate instruction , a home-based program can be a safe , low-cost alternative providing similar long-term ( 24 weeks ) exercise benefits in ACD PURPOSE The purpose of this r and omized trial was to compare the efficacy of a low-intensity exercise rehabilitation program vs a high-intensity program in changing physical function , peripheral circulation , and health-related quality of life in peripheral arterial disease ( PAD ) patients limited by intermittent claudication . METHODS Thirty-one patients r and omized to low-intensity exercise rehabilitation and 33 patients r and omized to high-intensity exercise rehabilitation completed the study . The 6-month exercise rehabilitation programs consisted of intermittent treadmill walking to near maximal claudication pain 3 days per week at either 40 % ( low-intensity group ) or 80 % ( high-intensity group ) of maximal exercise capacity . Total work performed in the two training regimens was similar by having the patients in the low-intensity group exercise for a longer duration than patients in the high-intensity group . Measurements of physical function , peripheral circulation , and health-related quality of life were obtained on each patient before and after the rehabilitation programs . RESULTS After the exercise rehabilitation programs , patients in the two groups had similar improvements in these measures . Initial claudication distance increased by 109 % in the low-intensity group ( P < .01 ) and by 109 % in the high-intensity group ( P < .01 ) , and absolute claudication distance increased by 61 % ( P < 0.01 ) and 63 % ( P < .01 ) in the low-intensity and high-intensity groups , respectively . Furthermore , both exercise programs elicited improvements ( P < .05 ) in peak oxygen uptake , ischemic window , and health-related quality of life . CONCLUSION The efficacy of low-intensity exercise rehabilitation is similar to high-intensity rehabilitation in improving markers of functional independence in PAD patients limited by intermittent claudication , provided that a few additional minutes of walking is accomplished to elicit a similar volume of exercise BACKGROUND The magnitude of potential changes in Quality -of-Life ( QoL ) after structured institution-based or home-based peripheral arterial disease ( PAD ) rehabilitation programs are largely unknown at present . This pilot study provides first QoL data after PAD rehabilitation or a home-based PAD training . PATIENTS AND METHODS In a non-r and omized , open-label pilot study three groups of out- patients were compared : group 1 ( n = 18 ) PAD rehabilitation ; group 2 ( n = 17 ) PAD rehabilitation + clopidogrel 75 mg once daily ; group 3 ( n = 20 ) home-based training .  The training period was 3 months , which was followed by a 3-month observation phase ( without prescribed training ) . The institution-based rehabilitation program consisted of 3 training hours per week whereas patients training at home were instructed to walk for 1 hour per day on an outdoor track . QoL assessment was performed using MOS SF-36 , PAVK-86 and PAD-WIQ question naires . RESULTS At baseline background variables , demographics and claudication distances were comparable between groups . After three months of training the percentage changes for the initial and the absolute claudication distance ( ICD , ACD ) for groups 1 , 2 , and 3 amounted to 164 % , 201 % , 44 % ( ICD ) and 83 % , 131 % , 5 % ( ACD ) , respectively . Statistically significant QoL improvements were recorded for physical functions , pain and disease related anxiety in all three study groups ; statistically significant inter-group differences were not found . CONCLUSIONS In sharp contrast to the development of the claudication distances the improvement in QoL , found after 3 months of training , was comparable and not consistently different between the groups Intermittent claudication is the primary symptom of peripheral arterial disease , affecting between 1 and 3 million Americans . Symptomatic improvement can be achieved by endovascular revascularization , but such procedures are invasive , expensive , and may be associated with procedural adverse events . Medical treatment options , including claudication medications and supervised exercise training , are also known to be effective , albeit also with associated limitations . The CLEVER ( Claudication : Exercise Vs . Endoluminal Revascularization ) study , funded by the Heart , Lung , and Blood Institute of the National Institutes of Health , is a prospect i ve , multicenter , r and omized , controlled clinical trial evaluating the relative efficacy , safety , and health economic impact of four treatment strategies for people with aortoiliac peripheral arterial disease and claudication . The treatment arms are : ( 1 ) optimal medical care ( claudication pharmacotherapy ) ; ( 2 ) primary stent placement ; ( 3 ) supervised exercise rehabilitation ; and ( 4 ) combined stenting with supervised exercise rehabilitation . The CLEVER study is a 5-year r and omized , controlled clinical trial to be conducted at approximately 25 centers in the United States that will monitor 252 patients and their responses to treatment during an 18-month follow-up period . The primary end point is change in maximum walking duration on a grade d treadmill test . Secondary end points include the change at 18 months in maximum walking duration from baseline , comparisons of free-living daily activity levels assessed by pedometer , health-related quality of life , and cost-effectiveness . Other analyses include the effect of these treatment strategies on anthropomorphic and physiologic variables , including body mass index , waist circumference , blood pressure , pulse pressure , and resting pulse as well as biochemical markers of cardiovascular health , including fasting lipids , fibrinogen , C-reactive protein , and hemoglobin A 1c values Abstract The CLaudication :  Exercise Vs Endoluminal Revascularization ( CLEVER ) study is the first r and omized , controlled , clinical , multicenter trial that is evaluating a supervised exercise program compared with revascularization procedures to treat claudication . In this report , the methods and dissemination techniques of the supervised exercise training intervention are described . A total of 217 participants are being recruited and r and omized to one of three arms : ( 1 ) optimal medical care ; ( 2 ) aortoiliac revascularization with stent ; or ( 3 ) supervised exercise training .  Of the enrolled patients , 84 will receive supervised exercise therapy . Supervised exercise will be administered according to a protocol design ed by a central CLEVER exercise training committee based on vali date d methods previously used in single center r and omized control trials . The protocol will be implemented at each site by an exercise committee member using training methods developed and st and ardized by the exercise training committee . The exercise training committee review s progress and compliance with the protocol of each participant weekly . In conclusion , a multicenter approach to disseminate the supervised exercise training technique and to evaluate its efficacy , safety and cost-effectiveness for patients with claudication due to peripheral arterial disease ( PAD ) is being evaluated for the first time in CLEVER . The CLEVER study will further establish the role of supervised exercise training in the treatment of claudication result ing from PAD and provide st and ardized methods for use of supervised exercise training in future PAD clinical trials as well as in clinical practice OBJECTIVE This r and omized controlled trial investigated the effects of upper- and lower-limb aerobic exercise training on disease-specific functional status and generic health-related quality of life ( QOL ) in patients with intermittent claudication . METHODS The study recruited 104 patients ( mean age , 68 years ; range , 50 - 85 ) from the Sheffield Vascular Institute . Patients were r and omly allocated to groups that received upper-limb ( ULG ) or lower-limb ( LLG ) aerobic exercise training , or to a nonexercise control group . Exercise was performed twice weekly for 24 weeks at equivalent limb-specific relative exercise intensities . Main outcome measures were scores on the Walking Impairment Question naire ( WIQ ) for disease-specific functional status , the Medical Outcomes Study Short Form version 2 ( SF-36v2 ) , and European Quality of Life Visual Analog Scale ( EQ-VAS ) for health-related QOL . Outcomes were assessed at baseline , and at 6 , 24 , 48 , and 72 weeks . RESULTS After 6 weeks , improvements in the perceived severity of claudication ( P = .023 ) and stair climbing ability ( P = .011 ) vs controls were observed in the ULG , and an improvement in the general health domain of the SF-36v2 vs controls was observed in the LLG ( P = .010 ) . After 24 weeks , all four WIQ domains were improved in the ULG vs controls ( P ≤ .05 ) , and three of the four WIQ domains were improved in the LLG ( P < .05 ) . After 24 to 72 weeks of follow-up , more consistent changes in generic health-related QOL domains were apparent in the ULG . CONCLUSIONS These findings support the use of alternative , relatively pain-free forms of exercise in the clinical management of patients with intermittent claudication
Nevertheless , there was " low-level " evidence that HEPs can improve walking capacity and quality of life in patients with intermittent claudication when compared with baseline or in comparison to usual care/observation control .
In addition , improvements with  HEPs  may be inferior to those evoked by supervised exercise training .
We aim ed to conduct a systematic review of the evidence for structured , home-based exercise programmes ( HEPs ) in patients with intermittent claudication .