Dataset Information

Supervised physical activity in patients with symptomatic peripheral arterial disease: protocol for a randomized clinical trial (ARTPERfit Study).

ABSTRACT:

Introduction

Peripheral arterial disease (PAD) is a marker of cardiovascular morbidity, causing disability, loss of mobility and poor quality of life, manifesting clinically in the form of intermittent claudication (IC). Physical exercise increases the distance walked and improves quality of life. The aim of our study will be increased walking distance prolonging the time of onset of pain in patients with symptomatic PAD (IC).

Methods and analysis

This study will be performed in Mataró Hospital's vascular surgery service and School of Health Sciences, TecnoCampus. This population comes from 15 primary healthcare centres ofNorth Barcelona, Spain (450 000 inhabitants).This study will be a four-group parallel, longitudinal, randomised controlled trial, blind to analysis.The main primary outcome of this study will be the improvement in pain-free walking distance. Others primary objectives are and improvement in functional status, quality of life and Ankle-Brachial Index (ABI). Secondary outcomes will be the analysis of cardiorespiratory fitness, evaluation of muscle fitness, determine the maintenance of primary objectives at 6 and 12 months.We will be included 124 patients (31 per group). The changes of the outcome (Barthel, SF-12, VascQOL-6, ABI) of the three intervention groups vs the control group at 3, 6 and 12 months will be compared, both continuously (linear regression) and categorically (logistic regression). A person who has not performed at least 75% of the training will be considered to have not completed the intervention.

Ethics and dissemination

The study will be conducted according to the Declaration of Helsinki . It was approved by the Ethics Committee of the Research Institute Primary Health IDIAP Jordi Gol (20/035 P),Barcelona 6 October 2020. Informed consent will be obtained from all patients before the start of the study. We will disseminate results through academic papers and conference presentations.

Trial registration number

NCT04578990.

SUBMITTER: Alzamora MT

PROVIDER: S-EPMC9047770 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature

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Publications

Supervised physical activity in patients with symptomatic peripheral arterial disease: protocol for a randomized clinical trial (ARTPERfit Study).

Alzamora Maria Teresa MT Forés Rosa R Serra Noemi N Martinez Esau E Pera Guillem G Seda Gemma G Lopez Palencia Joan J Gomis Manuel M Heras Tébar Antonio A Valverde Marta M Garnacho Manuel Vicente MV Torán Pere P

BMJ open 20220427 4

<h4>Introduction</h4>Peripheral arterial disease (PAD) is a marker of cardiovascular morbidity, causing disability, loss of mobility and poor quality of life, manifesting clinically in the form of intermittent claudication (IC). Physical exercise increases the distance walked and improves quality of life. The aim of our study will be increased walking distance prolonging the time of onset of pain in patients with symptomatic PAD (IC).<h4>Methods and analysis</h4>This study will be performed in M ...[more]

PMID: 35477870

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Project description:BackgroundPhysical exercise is a first-line treatment for peripheral arterial disease (PAD) and intermittent claudication (IC) reducing pain and increasing the distances walked. Home-based exercise therapy (HBET) has the advantage of reaching a higher number of patients and increasing adherence to physical exercise as it is performed in the patient's residential area and does not have the time, cost, and access restrictions of supervised exercise therapy (SET) implemented in a clinical setting. Even so, rates of adherence to physical exercise are relatively low, and therefore, m-health tools are promising in increasing motivation to behavior change and adherence to physical exercise. A built-in virtual assistant is a patient-focused tool available in a mobile interface, providing a variety of functions including health education, motivation, and implementation of behavior change techniques.MethodsThis is a single-center, prospective, three-arm, single-blind, randomized, controlled, superior clinical trial with stratified and blocked random allocation. Three hundred participants with PAD and IC will be recruited from an Angiology and Vascular Surgery Department, Centro Hospitalar Universitário Porto (CHUPorto), Porto, Portugal. All patients will receive the same medical care recommended by current guidelines. Participants in all three groups will receive a personalized prescription for an HBET program and a behavioral change and motivational intervention. Participants in experimental groups 1 and 2 will receive a smartphone with the WalkingPad app to monitor exercise sessions. Experimental group 2 WalkingPad app will have a built-in virtual assistant that will promote behavioral change and provide motivational support. Participants allocated to the active control group will not receive the m-health tool, but a practice diary to encourage monitoring. The program will last for 6 months with three evaluation moments (baseline, 3, and 6 months). The primary outcome will be the change in distances walked (maximal and pain-free) from baseline to 3 and 6 months. Secondary outcomes will be changes in quality of life, patients' perception of resistance, and walking speed.DiscussionThis study will allow measuring the effectiveness of an m-health tool in increasing motivation for behavior change and adherence to an HBET program in patients with PAD. The superiority of experimental group 2 in the primary and secondary outcomes will indicate that the virtual assistant is effective for motivating behavioral change and encouraging the practice and adherence to physical exercise. The use of m-health tools and virtual health assistants can potentially fill a gap in the access and quality of health services and information, reducing the burden on the health system and promoting self-management and self-care in chronic illness.Trial registrationClinicalTrials.gov NCT04749732 . Registered on 10 February 2021.

Project description:BackgroundMobile health interventions are intended to support complex health care needs in chronic diseases digitally, but they are mainly targeted at general health improvement and neglect disease-specific requirements. Therefore, we designed TrackPAD, a smartphone app to support supervised exercise training in patients with peripheral arterial disease.ObjectiveThis pilot study aimed to evaluate changes in the 6-minute walking distance (meters) as a primary outcome measure. The secondary outcome measures included changes in physical activity and assessing the patients' peripheral arterial disease-related quality of life.MethodsThis was a pilot two-arm, single-blinded, randomized controlled trial. Patients with symptomatic PAD (Fontaine stage IIa/b) and access to smartphones were eligible. Eligible participants were randomly assigned to the study, with the control group stratified by the distance covered in the 6-minute walking test using the TENALEA software. Participants randomized to the intervention group received usual care and the mobile intervention (TrackPAD) for the follow-up period of 3 months, whereas participants randomized to the control group received routine care only. TrackPAD records the frequency and duration of training sessions and pain levels using manual user input. Clinical outcome data were collected at the baseline and after 3 months via validated tools (the 6-minute walk test and self-reported quality of life). The usability and quality of the app were determined using the Mobile Application Rating Scale user version.ResultsThe intervention group (n=19) increased their mean 6-minute walking distance (83 meters, SD 72.2), while the control group (n=20) decreased their mean distance after 3 months of follow-up (-38.8 meters, SD 53.7; P=.01). The peripheral arterial disease-related quality of life increased significantly in terms of "symptom perception" and "limitations in physical functioning." Users' feedback showed increased motivation and a changed attitude toward performing supervised exercise training.ConclusionsBesides the rating providing a valuable support tool for the user group, the mobile intervention TrackPAD was linked to a change in prognosis-relevant outcome measures combined with enhanced coping with the disease. The influence of mobile interventions on long-term prognosis must be evaluated in the future.Trial registrationClinicalTrials.gov NCT04947228; https://clinicaltrials.gov/ct2/show/NCT04947228.

Project description:BACKGROUND:Peripheral arterial disease (PAD) is a common and severe disease with a highly increased cardiovascular morbidity and mortality. Through the circulatory disorder and the linked undersupply of oxygen carriers in the lower limbs, the ongoing decrease of the pain-free walking distance occurs with a significant reduction in patients' quality of life. Studies including activity monitoring for patients with PAD are rare and digital support to increase activity via mobile health technologies is mainly targeted at patients with cardiovascular disease in general. The special requirement of patients with PAD is the need to reach a certain pain level to improve the pain-free walking distance. Unfortunately, both poor adherence and availability of institutional resources are major problems in patient-centered care. OBJECTIVE:The objective of this trackPAD pilot study is to evaluate the feasibility of a mobile phone-based self tracking app to promote physical activity and supervised exercise therapy (SET) in particular. We also aim for a subsequent patient centered adjustment of the app prototype based on the results of the app evaluation and process evaluation. METHODS:This study was designed as a closed user group trial, with assessors blinded, and parallel group study with face-to-face components for assessment with a follow-up of 3 months. Patients with symptomatic PAD (Fontaine stage IIa or IIb) and possession of a mobile phone were eligible. Eligible participants were randomly assigned into study and control group, stratified by their distance covered in the 6-min walk test, using the software TENALEA. Participants randomized to the study group received usual care and the mobile intervention (trackPAD) for the follow-up period of 3 months, whereas participants randomized to the control group received only usual care. TrackPAD records the frequency and duration of training sessions and pain level using manual user input. Clinical outcome data were collected at the baseline and after 3 months via validated tools (6-min walk test, ankle-brachial index, and duplex ultrasound at the lower arteries) and self-reported quality of life. Usability and quality of the app was determined using the user version of the Mobile Application Rating Scale. RESULTS:The study enrolled 45 participants with symptomatic PAD (44% male). Of these participants, 21 (47%) were randomized to the study group and 24 (53%) were randomized to the control group. The distance walked in the 6-min walk test was comparable in both groups at baseline (study group: mean 368.1m [SD 77.6] vs control group: mean 394.6m [SD 100.6]). CONCLUSIONS:This is the first trial to test a mobile intervention called trackPAD that was designed especially for patients with PAD. Its results will provide important insights in terms of feasibility, effectiveness, and patient preferences of an app-based mobile intervention supporting SET for the conservative treatment of PAD. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/13651.

Project description:Physical activity is associated with the reduction of several chronic conditions in adults. Additionally, physical activity is extremely important for children for their development and cognitive functioning and also to create a physically active lifestyle that continues into adulthood. Despite the known benefits of physical activity, only one in five adults are achieving the public health recommendations of 150 minutes of moderate-to-vigorous physical activity per week and only 13 % of boys and 6 % of girls between the ages of 5 and 17 years are meeting the guidelines of 60 minutes per day. This study aims to evaluate whether a planning condition improves adherence to regular physical activity compared to an education-only control condition among families. Families are eligible if there is at least one child between the ages of 6 and 12 years who is not meeting the Canadian Physical Activity Guidelines.A six-month longitudinal randomized controlled trial will be used to compare the two conditions. Materials will be delivered at baseline with 'booster' sessions at six weeks and three months. Participants will be assessed at baseline and at six months with a fitness test, as well as questionnaires and accelerometery at baseline, six weeks, three months and six months. A total of 137 families have been recruited thus far from Greater Victoria. This study is ongoing and recruitment will continue until December 2015 with the target goal of reaching 160 families.This protocol describes the implementation of a randomized controlled trial that utilizes planning strategies to try and increase physical activity among families. Research findings could be useful in public health in providing effective strategies to families to help decrease sedentary lifestyles. Additionally, findings may help to inform future interventions aimed at increasing physical activity among families.This trial was registered on June 5, 2012 with the Clinical Trials Registry maintained by the National Library of Medicine at the National Institutes of Health. The registration ID is NCT01882192.

Project description:BackgroundDespite the significant health benefits of regular physical activity, approximately half of American adults, particularly women and minorities, do not meet the current physical activity recommendations. Mobile phone technologies are readily available, easily accessible and may provide a potentially powerful tool for delivering physical activity interventions. However, we need to understand how to effectively apply these mobile technologies to increase and maintain physical activity in physically inactive women. The purpose of this paper is to describe the study design and protocol of the mPED (mobile phone based physical activity education) randomized controlled clinical trial that examines the efficacy of a 3-month mobile phone and pedometer based physical activity intervention and compares two different 6-month maintenance interventions.MethodsA randomized controlled trial (RCT) with three arms; 1) PLUS (3-month mobile phone and pedometer based physical activity intervention and 6-month mobile phone diary maintenance intervention), 2) REGULAR (3-month mobile phone and pedometer based physical activity intervention and 6-month pedometer maintenance intervention), and 3) CONTROL (pedometer only, but no intervention will be conducted). A total of 192 physically inactive women who meet all inclusion criteria and successfully complete a 3-week run-in will be randomized into one of the three groups. The mobile phone serves as a means of delivering the physical activity intervention, setting individualized weekly physical activity goals, and providing self-monitoring (activity diary), immediate feedback and social support. The mobile phone also functions as a tool for communication and real-time data capture. The primary outcome is objectively measured physical activity.DiscussionIf efficacy of the intervention with a mobile phone is demonstrated, the results of this RCT will be able to provide new insights for current behavioral sciences and mHealth.Trial registrationClinicalTrials.gov#:NCTO1280812.

Dataset Information

Supervised physical activity in patients with symptomatic peripheral arterial disease: protocol for a randomized clinical trial (ARTPERfit Study).

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Supervised physical activity in patients with symptomatic peripheral arterial disease: protocol for a randomized clinical trial (ARTPERfit Study).

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