Perceived Versus Objective Change in Walking Ability in Peripheral Artery Disease: Results from 3 Randomized Clinical Trials of Exercise Therapy.
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SUBMITTER: McDermott MM
PROVIDER: S-EPMC8477873 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundRandomized trials of people with peripheral artery disease (PAD) and intermittent claudication have traditionally used maximal treadmill walking distance as the primary outcome, but the 6-minute walk test is increasingly used as a primary outcome in randomized trials of PAD. This study compared relative changes in maximal treadmill walking distance versus 6-minute walk distance in response to a therapeutic intervention or control in randomized trials of participants with PAD.MethodsData from four randomized trials of therapeutic interventions in participants with PAD that measured both 6-minute walk and treadmill walking performance at baseline and the 6-month follow-up were combined. Two trials studied supervised treadmill exercise, one studied home-based walking exercise, and one studied resveratrol.ResultsOf 467 participants (mean age, 69.8; standard deviation, 9.7), the mean ankle-brachial index was 0.66 (standard deviation, 0.17). At the 6-month follow-up, participants with PAD randomized to control or placebo significantly declined in 6-minute walk distance (-10.2 m; 95% confidence interval, -18.2 to -2.2; P = .013), but improved maximal treadmill walking distance (+25.7 m; 95% CI, +6.0 to +45.3 m; P = .010; difference between change in 6-minute walk versus maximal treadmill walking distance: -37.3 m; 95% CI, -56.4 to -18.2; P < .001). Home-based exercise improved the 6-minute walk distance by 43.2 m (95% CI, +28.4 to +57.9), and supervised treadmill exercise improved the 6-minute walk distance by 25.0 m (95% CI, +14.7 to +35.2; mean difference, +18.2 m favoring home-based exercise [95% CI, +0.2 to +36.2 m; P = .048]). Among all participants, the presence (vs absence) of treadmill exercise training was associated with a 141.3-m greater improvement in maximal treadmill walking distance compared to 6-minute walk distance (95% CI, 88.2-194.4; P < .001), suggesting a benefit from treadmill training on the treadmill outcome.ConclusionsMaximal treadmill walking distance and the 6-minute walk distance are not interchangeable outcomes in participants with PAD. Participants with PAD randomized to control groups improved treadmill walking distance but simultaneously meaningfully declined in 6-minute walk distance. Supervised treadmill exercise training amplified improvement in treadmill walking distance because of a training to the outcome measure phenomenon.
| S-EPMC7141750 | biostudies-literature
Project description:Exercise therapy in the intermediate stages of peripheral artery disease (PAD) represents an effective solution to improve mobility and quality of life (QoL). Home-based programs, although less effective than supervised programs, have been found to be successful when conducted at high intensity by walking near maximal pain. In this randomized trial, we aim to compare a low-intensity, pain-free structured home-based exercise (SHB) program to an active control group that will be advised to walk according to guidelines. Sixty PAD patients aged > 60 years with claudication will be randomized with a 1:1 ratio to SHB or Control. Patients in the training group will be prescribed an interval walking program at controlled speed to be performed at home; the speed will be increased weekly. At baseline and after 6 months, the following outcomes will be collected: pain-free walking distance and 6-min walking distance (primary outcome), ankle-brachial index, QoL by the VascuQoL-6 questionnaire, foot temperature by thermal camera, 5-time sit-to-stand test, and long-term clinical outcomes including revascularization rate and mortality. The home-based pain-free exercise program may represent a sustainable and cost effective option for patients and health services. The trial has been approved by the CE-AVEC Ethics Committee (898/20). Registration details: Clinicaltrials.gov NCT04751890 [Registered: 12 February 2021].
| S-EPMC8163172 | biostudies-literature
Project description:ImportanceHome-based walking exercise interventions are recommended for people with peripheral artery disease (PAD), but evidence of their efficacy has been mixed.ObjectiveTo investigate the effect of a home-based, walking exercise behavior change intervention delivered by physical therapists in adults with PAD and intermittent claudication compared with usual care.Design, setting, and participantsMulticenter randomized clinical trial including 190 adults with PAD and intermittent claudication in 6 hospitals in the United Kingdom between January 2018 and March 2020; final follow-up was September 8, 2020.InterventionsParticipants were randomized to receive a walking exercise behavior change intervention delivered by physical therapists trained to use a motivational approach (n = 95) or usual care (n = 95).Main outcomes and measuresThe primary outcome was 6-minute walking distance at 3-month follow-up (minimal clinically important difference, 8-20 m). There were 8 secondary outcomes, 3 of which were the Walking Estimated Limitation Calculated by History (WELCH) questionnaire (score range, 0 [best performance] to 100), the Brief Illness Perceptions Questionnaire (score range, 0 to 80 [80 indicates negative perception of illness]), and the Theory of Planned Behavior Questionnaire (score range, 3 to 21 [21 indicates best attitude, subjective norms, perceived behavioral control, or intentions]); a minimal clinically important difference was not defined for these instruments.ResultsAmong 190 randomized participants (mean age 68 years, 30% women, 79% White race, mean baseline 6-minute walking distance, 361.0 m), 148 (78%) completed 3-month follow-up. The 6-minute walking distance changed from 352.9 m at baseline to 380.6 m at 3 months in the intervention group and from 369.8 m to 372.1 m in the usual care group (adjusted mean between-group difference, 16.7 m [95% CI, 4.2 m to 29.2 m]; P = .009). Of the 8 secondary outcomes, 5 were not statistically significant. At 6-month follow-up, baseline WELCH scores changed from 18.0 to 27.8 in the intervention group and from 20.7 to 20.7 in the usual care group (adjusted mean between-group difference, 7.4 [95% CI, 2.5 to 12.3]; P = .003), scores on the Brief Illness Perceptions Questionnaire changed from 45.7 to 38.9 in the intervention group and from 44.0 to 45.8 in the usual care group (adjusted mean between-group difference, -6.6 [95% CI, -9.9 to -3.4]; P < .001), and scores on the attitude component of the Theory of Planned Behavior Questionnaire changed from 14.7 to 15.4 in the intervention group and from 14.6 to 13.9 in the usual care group (adjusted mean between-group difference, 1.4 [95% CI, 0.3 to 2.5]; P = .02). Thirteen serious adverse events occurred in the intervention group, compared with 3 in the usual care group. All were determined to be unrelated or unlikely to be related to the study.Conclusions and relevanceAmong adults with PAD and intermittent claudication, a home-based, walking exercise behavior change intervention, compared with usual care, resulted in improved walking distance at 3 months. Further research is needed to determine the durability of these findings.Trial registrationsISRCTN Identifier: 14501418; ClinicalTrials.gov Identifier: NCT03238222.
| S-EPMC9006109 | biostudies-literature
Project description:Clinical practice guidelines state there is insufficient evidence to support advising patients with peripheral artery disease (PAD) to participate in a home-based walking exercise program.To determine whether a home-based walking exercise program that uses a group-mediated cognitive behavioral intervention, incorporating both group support and self-regulatory skills, can improve functional performance compared with a health education control group in patients with PAD with and without intermittent claudication.Randomized controlled clinical trial of 194 patients with PAD, including 72.2% without classic symptoms of intermittent claudication, performed in Chicago, Illinois between July 22, 2008, and December 14, 2012.Participants were randomized to 1 of 2 parallel groups: a home-based group-mediated cognitive behavioral walking intervention or an attention control condition.The primary outcome was 6-month change in 6-minute walk performance. Secondary outcomes included 6-month change in treadmill walking, physical activity, the Walking Impairment Questionnaire (WIQ), and Physical and Mental Health Composite Scores from the 12-item Short-Form Health Survey.Participants randomized to the intervention group significantly increased their 6-minute walk distance ([reported in meters] 357.4 to 399.8 vs 353.3 to 342.2 for those in the control group; mean difference, 53.5 [95% CI, 33.2 to 73.8]; P?<?.001), maximal treadmill walking time (intervention, 7.91 to 9.44 minutes vs control, 7.56 to 8.09; mean difference, 1.01 minutes [95% CI, 0.07 to 1.95]; P?=?.04), accelerometer-measured physical activity over 7 days (intervention, 778.0 to 866.1 vs control, 671.6 to 645.0; mean difference, 114.7 activity units [95% CI, 12.82 to 216.5]; P?=?.03), WIQ distance score (intervention, 35.3 to 47.4 vs control, 33.3 to 34.4; mean difference, 11.1 [95% CI, 3.9 to 18.1]; P?=?.003), and WIQ speed score (intervention, 36.1 to 47.7 vs control, 35.3-36.6; mean difference, 10.4 [95% CI, 3.4 to 17.4]; P?=?.004).A home-based walking exercise program significantly improved walking endurance, physical activity, and patient-perceived walking endurance and speed in PAD participants with and without classic claudication symptoms. These findings have implications for the large number of patients with PAD who are unable or unwilling to participate in supervised exercise programs.clinicaltrials.gov Identifier: NCT00693940.
| S-EPMC6007977 | biostudies-literature
Project description:We compared the changes in ambulatory outcomes between men and women with symptomatic peripheral arterial disease (PAD) following completion of a supervised, on-site, treadmill exercise program, and we determined whether exercise training variables and baseline clinical characteristics were predictive of changes in ambulatory outcomes in men and women. Twenty-three men and 25 women completed the supervised exercise program, consisting of intermittent walking to mild-to-moderate claudication pain for three months. Men and women significantly increased claudication onset time (COT) (p < 0.001 and p < 0.01, resp.) and peak walking time (PWT) (p < 0.001 for each group). However, change in PWT was less in women (54%) than in men (77%) (p < 0.05). Neither group significantly changed 6-minute walk distance (6MWD). In women, baseline COT was the only predictor for the change in COT (p = 0.007) and the change in PWT (p = 0.094). In men, baseline COT (p < 0.01) and obesity (p < 0.10) were predictors for the change in COT, and obesity was the only predictor for the change in PWT (p = 0.002). Following a supervised, on-site, treadmill exercise program, women had less improvement in PWT than men, and neither men nor women improved submaximal, overground 6MWD. Furthermore, obese men and patients with lower baseline COT were least responsive to supervised exercise. This trial is registered with ClinicalTrial.gov, unique identifier: NCT00618670.
| S-EPMC5220567 | biostudies-literature
Project description:Background: This study aimed to investigate whether home exercise programs informed by wearable activity monitors improved walking ability of patients with peripheral artery disease (PAD). Methods: A systematic literature search was performed to identify randomised controlled trials (RCT) testing home exercise that were or were not informed by wearable activity monitors. The primary outcome was the change in walking distance measured by a six-minute walking test or treadmill test over the course of the trial. Network meta-analysis (NMA) was performed using the gemtc R statistical package. The risk of bias was assessed using Cochrane tool for assessing risk of bias in RCTs (RoB 2.0). Results: A total of 14 RCTs involving 1544 participants were included. Nine trials used wearable activity monitors to inform the home exercise program tested, while five trials did not use wearable activity monitors to inform the home exercise program tested. Overall quality assessment showed 12 trials to be at low risk of bias and two trials at high risk of bias. Home exercise programs informed by wearable activity monitors significantly improved walking distance compared to non-exercise controls (Mean difference, MD: 32.8 m [95% credible interval, CrI: 6.1, 71.0]) but not compared to home exercise programs not informed by wearable activity monitors (MD: 4.7 m [95% CrI: -38.5, 55.4]). Conclusions: Home exercise informed by wearable activity monitors improve walking ability of patients with PAD. It is, however, unclear if activity monitoring informed exercise programs are more effective than exercise programs not using activity monitors.
| S-EPMC9611238 | biostudies-literature
Project description:ImportanceFew people with lower extremity peripheral artery disease (PAD) participate in supervised treadmill exercise covered by the Center for Medicare and Medicaid Services. In people with PAD, the benefits of home-based walking exercise, relative to supervised exercise, remain unclear.ObjectiveTo study whether home-based walking exercise improves 6-minute walk (6MW) more than supervised treadmill exercise in people with PAD (defined as Ankle Brachial Index ≤0.90).Data sourcesData were combined from 5 randomized clinical trials of exercise therapy for PAD using individual participant data meta-analyses, published from 2009 to 2022.Study selectionOf the 5 clinical trials, 3 clinical trials compared supervised treadmill exercise to nonexercise control (N = 370) and 2 clinical trials compared an effective home-based walking exercise intervention to nonexercise control (N = 349).Data extraction and synthesisIndividual participant-level data from 5 randomized clinical trials led by 1 investigative team were combined. The 5 randomized clinical trials included 3 clinical trials of supervised treadmill exercise and 2 effective home-based walking exercise interventions.Main outcomes and measuresChange in 6MW distance, maximum treadmill walking distance, and Walking Impairment Questionnaire at 6-month follow-up. The supervised treadmill exercise intervention consisted of treadmill exercise in the presence of an exercise physiologist, conducted 3 days weekly for up to 50 minutes per session. Home-based walking exercise consisted of a behavioral intervention in which a coach helped participants walk for exercise in or around home for up to 5 days per week for 50 minutes per session.ResultsA total of 719 participants with PAD (mean [SD] age, 68.8 [9.5] years; 46.5% female) were included (349 in a home-based exercise clinical trial and 370 in a supervised exercise trial). Compared with nonexercise control, supervised treadmill exercise was associated with significantly improved 6MW by 32.9 m (95% CI, 20.6-45.6; P < .001) and home-based walking exercise was associated with significantly improved 6MW by 50.7 m (95% CI, 34.8-66.7; P < .001). Compared with supervised treadmill exercise, home-based walking exercise was associated with significantly greater improvement in 6MW distance (between-group difference: 23.8 m [95% CI, 3.6, 44.0; P = .02]) but significantly less improvement in maximum treadmill walking distance (between-group difference:-132.5 m [95% CI, -192.9 to -72.1; P < .001]).Conclusions and relevanceIn this individual participant data meta-analyses, compared with supervised exercise, home-based walking exercise was associated with greater improvement in 6MW in people with PAD. These findings support home-based walking exercise as a first-line therapy for walking limitations in PAD.
| S-EPMC10514734 | biostudies-literature
Project description:Our aim was to determine whether pharmacologic vasodilation is an alternative to exercise stress during limb perfusion imaging for peripheral artery disease (PAD).Quantitative contrast-enhanced ultrasound (CEU) perfusion imaging of the bilateral anterior thigh and calf was performed in nine control subjects and nine patients with moderate to severe PAD at rest and during vasodilator stress with dipyridamole. For those who were able, CEU of the calf was then performed during modest plantar flexion exercise (20 watts). CEU time-intensity data were analyzed to quantify microvascular blood flow (MBF) and its parametric components of microvascular blood volume and flux rate.Thigh and calf skeletal muscle MBF at rest was similar between control and PAD patients. During dipyridamole, MBF increased minimally (<twofold) for all groups and there were only nonsignificant trends for a reduction in calf MBF in those with PAD (13.5±6.9, 10.0±4.7, and 8.2±6.1 IU/s, for controls, moderate, and severe PAD, respectively; P=.11). In contrast, MBF during modest planar flexion exercise increased markedly in controls but not PAD patients (87.9±79.9 vs 15.2±12.9 IU/s, P<.05). In three moderate PAD patients restudied after undergoing surgical revascularization, MBF during dipyridamole did not change, whereas exercise MBF increased by an average of sevenfold.Resting limb skeletal muscle MBF in patients with moderate to severe PAD is similar to that in normal subjects. However, differences in hyperemic flow during contractile exercise but not during dipyridamole allow evaluation of the degree of flow impairment from PAD and the degree of improvement with revascularization.
| S-EPMC5568936 | biostudies-literature
Project description:Backgroundolder persons can be grouped according to their objective risk of falling (ORF) and perceived risk of falling (PRF) into 'vigorous' (low ORF/PRF), 'anxious' (low ORF/high PRF), 'stoic' (high ORF/low PRF) and 'aware' (high ORF/PRF). Sensor-assessed daily walking activity of these four groups has not been investigated, yet.Objectivewe examined everyday walking activity in those four groups and its association with ORF and PRF.Designcross-sectional.Settingcommunity.SubjectsN = 294 participants aged 70 years and older.MethodsORF was determined based on multiple independent risk factors; PRF was determined based on the Short Falls Efficacy Scale-International. Subjects were allocated to the four groups accordingly. Linear regression was used to quantify the associations of these groups with the mean number of accelerometer-assessed steps per day over 1 week as the dependent variable. 'Vigorous' was used as the reference group.Resultsaverage number of steps per day in the four groups were 6,339 ('vigorous'), 5,781 ('anxious'), 4,555 ('stoic') and 4,528 ('aware'). Compared with the 'vigorous', 'stoic' (-1,482; confidence interval (CI): -2,473; -491) and 'aware' (-1,481; CI: -2,504; -458) participants took significantly less steps, but not the 'anxious' (-580 steps; CI: -1,440; 280).Conclusionwe have integrated a digital mobility outcome into a fall risk categorisation based on ORF and PRF. Steps per day in this sample of community-dwelling older persons were in accordance with their ORF rather than their PRF. Whether this grouping approach can be used for the specification of participants' needs when taking part in programmes to prevent falls and simultaneously promote physical activity remains to be answered in intervention studies.
| S-EPMC8437067 | biostudies-literature
Project description:This study aimed to investigate the effects of supervised exercise training (SET) on spatiotemporal gait and foot kinematics parameters in patients with symptomatic lower extremity peripheral artery disease (PAD) during a 6 min walk test. Symptomatic patients with chronic PAD (Fontaine stage II) following a 3 month SET program were included. Prior to and following SET, a 6 min walk test was performed to assess the 6 min walking distance (6MWD) of each patient. During this test, spatiotemporal gait and foot kinematics parameters were assessed during pain-free and painful walking conditions. Twenty-nine patients with PAD (65.4 ± 9.9 years.) were included. The 6MWD was significantly increased following SET (+10%; p ≤ 0.001). The walking speed (+8%) and stride frequency (+5%) were significantly increased after SET (p ≤ 0.026). The stride length was only significantly increased during the pain-free walking condition (+4%, p = 0.001), whereas no significant differences were observed during the condition of painful walking. Similarly, following SET, the relative duration of the loading response increased (+12%), the relative duration of the foot-flat phase decreased (-3%), and the toe-off pitch angle significantly increased (+3%) during the pain-free walking condition alone (p ≤ 0.05). A significant positive correlation was found between changes in the stride length (r = 0.497, p = 0.007) and stride frequency (r = 0.786, p ≤ 0.001) during pain-free walking condition and changes in the 6MWD. A significant negative correlation was found between changes in the foot-flat phase during pain-free walking condition and changes in the 6MWD (r = -0.567, p = 0.002). SET was found to modify the gait pattern of patients with symptomatic PAD, and many of these changes were found to occur during pain-free walking. The improvement in individuals' functional 6 min walk test was related to changes in their gait pattern.
| S-EPMC8659842 | biostudies-literature