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Effects of a home-based walking intervention on mobility and quality of life in people with diabetes and peripheral arterial disease: a randomized controlled trial.

ABSTRACT: Determine the efficacy of a home-based walking intervention to improve walking ability and quality of life in people with diabetes and peripheral arterial disease (PAD).We conducted a randomized, controlled, single-blind trial within university-affiliated clinics in our local community. We randomized 145 participants (45 women) with diabetes and PAD to our intervention--a 6-month behavioral intervention targeting levels of readiness to engage in routine walking for exercise--versus attention control. Our primary outcome was 6-month change in maximal treadmill walking distance. Secondary outcomes included 3-month change in maximal walking distance, lower limb function (i.e., walking impairment scores), quality of life (Medical Outcomes Short Form Survey), exercise behaviors, depressive symptoms, and self-efficacy at 3 and 6 months.The mean age of participants was 66.5 (SD 10.1) years. Intervention and control groups did not differ significantly in 6-month change in maximal treadmill walking distance (average [SE] 24.5 [19.6] meters vs. 39.2 [19.6] meters; P = 0.60). Among secondary outcomes, for the intervention and control groups, respectively, average walking speed scores increased by 5.7 [2.2] units and decreased by 1.9 [2.8] units (P = 0.03); the mental health quality of life subscale score increased by 3.2 [1.5] and decreased by 2.4 [1.5] units (P = 0.01).A home-based walking intervention did not improve walking distance but did improve walking speed and quality of life in people with diabetes and PAD. Clinicians should consider recommending home-based walking therapy for such patients.

SUBMITTER: Collins TC

PROVIDER: S-EPMC3177730 | biostudies-literature | 2011 Oct

REPOSITORIES: biostudies-literature

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Effects of a home-based walking intervention on mobility and quality of life in people with diabetes and peripheral arterial disease: a randomized controlled trial.

Collins Tracie C TC Lunos Scott S Carlson Teri T Henderson Kimberly K Lightbourne Marissa M Nelson Brittney B Hodges James S JS

Diabetes care 20110826 10

<h4>Objective</h4>Determine the efficacy of a home-based walking intervention to improve walking ability and quality of life in people with diabetes and peripheral arterial disease (PAD).<h4>Research design and methods</h4>We conducted a randomized, controlled, single-blind trial within university-affiliated clinics in our local community. We randomized 145 participants (45 women) with diabetes and PAD to our intervention--a 6-month behavioral intervention targeting levels of readiness to engage ...[more]

PMID: 21873560

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Project description:AimsInvestigate whether a Home-based Exercise Therapy (HBET) program for patients with Peripheral Arterial Disease (PAD) and Intermittent Claudication (IC) with a behavior change intervention, supported by a smartphone application, is effective in improving walking distances and performance, and quality of life (QoL) over 6 months.Methods and resultsThis was a single-center, prospective, two-arm, single-blinded randomized controlled trial including 73 patients with PAD and IC, and three assessment moments: baseline, 3, and 6 months. Participants were randomized to receive a walking exercise prescription, with the support (n = 38) or without the support (n = 35) of the WalkingPad app, between January 2021 and July 2022. Both groups received two face-to-face behavior change sessions and 12 structured and targeted reinforcement phone calls over 6 months. Primary outcomes were between-group differences in pain-free walking distance (PFWD), functional walking distance (FWD), maximal walking distance (MWD), and 6-min walk distance (6 MWD) at 3 and 6 months. Secondary outcomes were QoL and walking impairment. Seventy-three patients (mean age 64 ± 7.2 years, 88% men) participated in this study, 60 of whom completed the three assessment moments. The whole sample significantly improved all primary outcomes in the first 3 months; that is, the average PFWD (151.1 m), FWD (175.2 m), MWD (171.1 m), and 6 MWD (30.8 m) increased from T1 to T2. Only MWD exhibited a significant average increase (35.0 m). Secondary outcomes also increased from baseline to 3 and 6 months. There were no between-group differences, except for MWD, which showed a greater increase at 6 months in the group that used the app, excluding patients with weak walking ability and extreme anxiety symptoms at baseline.ConclusionThe intervention improved distances and walking skills as well as the physical, mental, and disease-related quality of life among adults with PAD and IC. The group that used the WalkingPad app improved their MWD in 6 months compared to the control group, except for patients with poor walking ability and extreme anxiety symptoms, which suggests the effectiveness of the WalkingPad app for patients with high walking ability and no severe anxiety symptoms. More research is needed to determine the durability of these findings and to explore what app functionality might promote the other outcomes.Clinical trial registrationhttps://clinicaltrials.gov (NCT04749732).

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.

Project description:During the past decade an increasing number of people live with advanced cancer mainly due to improved medical treatment. Research has shown that many people with advanced cancer have problems with everyday activities, which have negative impact on their quality of life, and that they spend a considerable part of their time at home. Still, research on interventions to support the performance of and participation in everyday activities is only scarcely available. Therefore, the occupational therapy-based "Cancer Home-Life Intervention" consisting of tailored adaptive interventions applied in the participant's home environment was developed. The objective of this study is to examine the effectiveness and cost-effectiveness of the Cancer Home-Life Intervention compared to usual care on the performance of and participation in everyday activities and quality of life in people with advanced cancer living at home.The study is a randomised, controlled trial (RCT) including an economic evaluation. The required sample size of 272 adults living at home will be recruited from outpatient clinics at two Danish hospitals. They should be diagnosed with cancer; evaluated incurable by the responsible oncologist; and with a functional level 1-2 on the WHO performance scale. The primary outcome is the quality of performance of activities of daily living. Secondary outcomes are problems with prioritised everyday activities; autonomy and participation; and health-related quality of life. Participants are randomly assigned to: a) The Cancer Home-Life Intervention in addition to usual care, and b) Usual care alone.The trial will show whether the Cancer Home-Life Intervention provides better support for people with advanced cancer living at home in performing and participating in everyday activities, and whether it contributes to their health-related quality of life. The economic evaluation alongside the RCT will show if the Cancer Home-Life Intervention is cost-effective. The trial will also show the acceptability of the intervention to the target group, and whether subgroups of participants will benefit more than others.ClinicalTrials.gov Identifier NCT02356627. Registered 02/02/2015.

Project description:IntroductionPeripheral arterial disease (PAD) is increasingly prevalent, and supervised physical exercise programmes are recommended as the first-line treatment. However, these programmes are underused. Alternative delivery models may be able to expand treatment coverage. The objective of this study was to compare a home-based exercise programme (HBEP) and a centre-based exercise (CBE) in terms of their effects on functional capacity, peripheral muscle oxygenation and quality of life in individuals with PAD.Methods and analysisThis single-blind, parallel randomised clinical trial will consist of two groups: HBEP and CBE. A qualitative analysis will be carried out to investigate acceptability and satisfaction. The primary outcome will be functional capacity, assessed by the incremental shuttle walk test. Secondary outcomes will include functional capacity, assessed by a treadmill walking test; peripheral muscle oxygenation and quality of life; and self-reported functional impairment, risk factors, morbidity, level of physical activity, adherence, acceptability and satisfaction. The intervention protocols will consist of 12 weeks of intermittent walking until claudication symptoms, three times a week. Participants randomly assigned to the CBE group will participate in supervised face-to-face sessions. The HBEP group will perform exercises at home with remote supervision, monitored by a pedometer and heart rate monitor, and subjective perception of effort during each session will be recorded by participants in a training diary; follow-up will be conducted by telephone calls. Statistical analyses will follow the intention-to-treat principle. Participants allocated to the HBEP group will be interviewed about their experience of remote treatment using a qualitative approach.Ethics and disseminationEthics approval was obtained from the Ethics Committee of the Universidade Federal de Minas Gerais. The results will be disseminated in a peer-reviewed journal and presented at international congresses. This research has the potential to improve the care of people with PAD because if home-based rehabilitation demonstrates effectiveness, it could be considered an alternative or support resource to the usual centre-based treatment models, expanding access, coverage and participation in vascular physiotherapy TRIAL REGISTRATION: https://ensaiosclinicos.gov.br/rg/RBR-97vy9n7 on 14 April 2022.

Project description:BackgroundElderly people have high rates of functional decline, which compromises independence, self-confidence, and quality of life (QoL). Physical exercise leads to significant improvements in strength, balance, functional mobility, and QoL, but there is still reduced access to this therapeutic strategy due to difficulties in locomotion to training centers or lack of adaptation to the exercise environment.Methods/designThe purpose of this clinical trial will be to verify the effect of a progressive and semi-supervised, home-based exercise program on the functional mobility, and in the QoL of sedentary elderly people. This is a protocol of a consecutive, single-center, single-blind, and randomized controlled trial. The design, conduct, and report follows the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Sedentary elderly people will be enrolled, and randomly allocated into two groups. The intervention group will perform exercises in their own home and the control group will not perform exercises. The evaluations will occur at study enrollment and after 3 months of intervention, and will be performed using the functional mobility Timed Up & Go (TUG) test and sociodemographic and QoL questionnaires. In the statistical analysis, comparisons of mean and correlation analyses will be performed. The primary expected outcome is the improvement in functional mobility verified through the TUG test and the secondary outcome is the improvement in QoL verified by the WHOQOL-OLD.DiscussionThe lack of scientific evidence demonstrating the benefits of semi-supervised home exercise on functional mobility and QoL in elderly people represents an obstacle to the development of guidelines for clinical practice and for policy-makers. The World Health Organization highlighted the importance of musculoskeletal health programs for elderly people, and the exercise program described in this protocol was designed to be viable, easy to implement, and inexpensive, and could be performed at the home of elderly subjects after receiving only guidelines and follow-up via periodic visits. Based on these facts, we hope that this study will demonstrate that a well-structured, home-based exercise program can be effective in improving functional mobility and QoL of sedentary elderly people, even without constant supervision during exercise.Trial registrationRegistro Brasileiro de Ensaios Clínicos (ReBEC), Identifier: RBR-3cqzfy . Registered on 2 December 2016.

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.

Project description:BackgroundStay-at-home orders associated with the SARS-CoV-2 (COVID-19) pandemic were particularly important for older adults with type 2 diabetes, at risk for severe COVID-19 complications. In response, research shifted to remote telehealth methodology. Study participant interests, equipment needs, and ability to adapt methods to the remote/telehealth environment were unknown. Study purposes to assess (1) resource needs (internet/devices accessibility), (2) future telehealth interests, and (3) ability to adapt common research and clinical measures of glycemic control, physical function, activity measures, and quality of life outcomes to a telehealth setting.MethodTwenty-one participants with type 2 diabetes and peripheral neuropathy were recruited from a longitudinal study (11 female; age: 66.3 ± 8.3 years; DM: 15.1 ± 8.7 years). Technology needs and future telehealth interests were assessed. A glycemic measure (HbA1c), a five-times chair rise, a one-week activity monitor, and surveys (self-efficacy, depression, and balance) were collected. All aspects of the study were completed remotely over email and video/phone call.ResultsTwelve participants used computers; nine used phones for study completion. Participants had the following resource needs: connectivity (n = 3), devices (n = 6), and technical support (n = 12). Twenty people expressed interest in participating in future telehealth studies related to balance, exercise, and diabetes management. Methodological considerations were primarily the need for assistance for participants to complete the home HbA1c test, five-time chair rise, wearable activity monitoring, and surveys.ConclusionsOlder adults with type 2 diabetes and peripheral neuropathy would need technological and personal assistance (connection, device, guidance) to complete a long-term telehealth intervention. Despite technology needs, participants were interested in telehealth interventions.Clinical trialParent study, "Metatarsal Phalangeal Joint Deformity Progression-R01 (NCT02616263) is registered at https://clinicaltrials.gov/.

Dataset Information

Effects of a home-based walking intervention on mobility and quality of life in people with diabetes and peripheral arterial disease: a randomized controlled trial.

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Effects of a home-based walking intervention on mobility and quality of life in people with diabetes and peripheral arterial disease: a randomized controlled trial.

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