Home-based Exercise Therapy for Patients With PAD

NCT04749732 | Unknown

• 1 other identifier: 069-DEFI/068-CES
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular disease represents a considerable economic burden to society and effective preventive measures are necessary. Patients with peripheral arterial disease (PAD) have a severe impairment of functional ability, namely in walking distance due to muscle ischemia defined as intermittent claudication (IC). The discomfort related to IC contributes to a sedentary lifestyle, decreasing physical fitness level, aggravating cardiovascular risk factors leading to disease deterioration. Exercise programs are an effective, low-cost, low-risk option compared with more invasive therapies for IC. Home-based exercise therapy (HBET) is structured, unsupervised, self-directed programs that take place in the personal setting of the patient rather than in a clinical setting. HBET program implementation is feasible and eliminates barriers such as transportation issues, proximity to clinics, and conflicts with occupational responsibilities. Even though these programs have shown to be effective at improving walking performance and distance, their results fall below those seen in Supervised Exercise Therapy (SET) programs. Thus, innovative home-based walking programs need to be developed in order to improve results and make exercise therapy available to a larger percentage of the population. The use of Information and communication technology (ICT) tools for self-monitoring is considered key to change long-term behavior. The WalkingPAD project aims to develop health technology assessment methods and evaluate personal health intervention strategies. Investigators intend to demonstrate the technical feasibility and economic viability of a personalized medicine application in real-life healthcare settings. This project intends to find evidence for three major questions: Does an M-health monitored home-based exercise program supported by a virtual assistant empowers commitment to exercise plan and allows remote control of plan accomplishment? Is it superior to an M-health monitored home-based exercise program supported by a behavioral motivational intervention, in increasing maximum walking distance? Is it superior to a self-monitoring exercise, with a specific self-designed walking plan in the residence area, in increasing maximum walking distance?

Conditions

Peripheral Arterial Disease (PAD); Intermittent Claudication

Keywords

Peripheral Arterial Disease; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Intermittent Claudication; Walking ability; Health-related Quality of Life; Home-based Exercise Therapy; Pervasive virtual assistant

Outcome Measures

Primary Outcomes (3)

• Maximum Walking Distance (MWD)

  Maximum Walking Distance will be measured through the Treadmill Test and the 6 Minute Walk Test (6 MWT), in meters. The 6 MWT is a performance-based measure that evaluates the functional capacity of the individual to walk over a total of 6 min on a 100ft (≈30m) hallway, providing information regarding all the systems during physical activity.

  Changes from before-assignment (T0 - treadmill and T1 - 6min walk test) to T2 (3 months), and to T3 (six-months)

• Pain-free Walking Distance (PFWD)

  Pain-free Walking Distance (PFWD) will be measured through the Treadmill Test and the 6 Minute Walk Test (6 MWT), in meters. The 6 MWT is a performance-based measure that evaluates the functional capacity of the individual to walk over a total of 6 min on a 100ft (≈30m) hallway, providing information regarding all the systems during physical activity.

  Changes from before-assignment (T0 - treadmill and T1 - 6min walk test) to T2 (3 months), and to T3 (six-months)

• Functional Walking Distance (FWD)

  Functional Walking Distance (FWD) will be measured through the Treadmill Test and the 6 Minute Walk Test (6 MWT), in meters. The 6 MWT is a performance-based measure that evaluates the functional capacity of the individual to walk over a total of 6 min on a 100ft (≈30m) hallway, providing information regarding all the systems during physical activity.

  Changes from before-assignment (T0 - treadmill and T1 - 6min walk test) to T2 (3 months), and to T3 (six-months)

Secondary Outcomes (4)

• Physical Quality of Life

  Changes from T0 (before-assignment) to T2 (3 months), and to T3 (six-months)

• Mental Quality of Life

  Changes from T0 (before-assignment) to T2 (3 months), and to T3 (six-months)

• Vascular Disease specific Quality of Life

  Changes from T0 (before-assignment) to T2 (3 months), and to T3 (six-months)

• Walking Impairment

  Changes from T0 (before-assignment) to T2 (3 months), and to T3 (six-months)

Other Outcomes (23)

• Sociodemographic Data

  T0 (before-assignment)

• Clinical Data

  T1 (before intervention) to T2 (3 months), and to T3 (six-months)

• Ankle-brachial-index (ABI)

  T1 (before intervention) to T2 (3 months), and to T3 (six-months)

Study Arms (3)

WalkingPad plus Psychological Intervention - PsyWPad Group

EXPERIMENTAL

The participants in Experimental Group 1 will receive a prescription of an HBET consisting of a walking plan with a duration greater than 30 min per session, frequency of at least three sessions per week, use of near-maximal pain during training as claudication pain endpoint, with the support of a behavioral motivational intervention delivered by a health psychologist.

Behavioral: WalkingPad plus Psychological Intervention - PsyWPad Group

WalkingPad plus Virtual Assistant - CyberWPad Group

EXPERIMENTAL

The participants in Experimental Group 2 will receive a prescription of an HbET consisting of a walking plan with a duration greater than 30 min per session, frequency of at least three sessions per week, use of near-maximal pain during training as claudication pain endpoint, with the support of a virtual assistant that will give motivational support.

Behavioral: WalkingPad plus Virtual Assistant - CyberWPad Group

Paper WalkingPad group - PaperWPad Group

ACTIVE COMPARATOR

The participants in the Active Control Group will receive a prescription of an HbET consisting of a walking plan with a duration greater than 30 min per session, frequency of at least three sessions per week, use of near-maximal pain during training as claudication pain endpoint, with the support of a behavioral motivational intervention delivered by a health psychologist.

Behavioral: WalkingPad group - Paper WPad Group

Interventions

WalkingPad plus Psychological Intervention - PsyWPad Group BEHAVIORAL

The 24-week walking program will be monitored by the WalkingPAD application that will accompany the patient on their walks and record their adherence to the previously defined individual program. Motivational support for a behavioral intervention will include two face-to-face sessions and the following contacts will be made over the phone. The behavioral motivational intervention will follow the principles of 1) motivational interview, will be based on 2) Theory of self-determination, taking into account 3) components of the Transtheoretical Model of Change and the Theory of Planned Behavior.

Also known as: Behavioral Change

WalkingPad plus Psychological Intervention - PsyWPad Group

WalkingPad plus Virtual Assistant - CyberWPad Group BEHAVIORAL

The 24-week walking program will be monitored by the WalkingPAD application, which will accompany the patient on their walks and record their adherence to the previously defined individual program. Motivational support will be provided by a virtual assistant through daily and on-the-spot interactions and through support and motivational messages.

Also known as: Behavioral Change

WalkingPad plus Virtual Assistant - CyberWPad Group

WalkingPad group - Paper WPad Group BEHAVIORAL

The 24-week walking program will be supported by a printed prescription of an individualized HbET previously defined on the WalkingPAD platform. However, this group of patients will not have the support of an application to monitor and record adherence to the program. Motivational support for a behavioral intervention will include two face-to-face sessions and the following contacts will be made over the phone. The behavioral motivational intervention will follow the principles of 1) motivational interview, will be based on 2) Theory of self-determination, taking into account 3) components of the Trans-Theoretical Model of Change and the Theory of Planned Behavior.

Also known as: Behavioral Change

Paper WalkingPad group - PaperWPad Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PAD with IC (Fontaine II ou Rutherford 1-3) due to atherosclerotic disease;
• ABI below 0.9 at rest or below 0.73 after exercise (20% decrease);
• Age range between 50 and 80;
• MWD in treadmill test between 50 and 500 meters;

You may not qualify if:

• Asymptomatic PAD;
• Critical Ischemia (Fontaine III/IV or Rutherford 4-6);
• Previous lower extremity vascular surgery, angioplasty, or lumbar sympathectomy;
• Any condition other than PAD that limits walking;
• Miocardial Infarction or Unstable Angina in the last 6 months;
• Inability to obtain ABI measure because of non-compressible vessels;
• Use of cilostazol and pentoxifylline initiated within 3 months before the investigation;
• Active cancer, renal disease, or liver disease;
• Severe chronic obstructive pulmonary disease (GOLD stage III/IV);
• Severe congestive heart failure (NYHA class III/IV);

Sponsors & Collaborators

• Centro Hospitalar do Porto: lead
• Foundation for Science and Technology, Portugal: collaborator
• University of Trás-os-Montes and Alto Douro: collaborator
• Institute for Systems and Computer Engineering, Technology and Science-INESC TEC: collaborator

Study Sites (1)

Centro Hospitalar do Porto

Porto, 4099-001, Portugal

RECRUITING

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MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ivone Heitor, PhD

  Centro Hospitalar do Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivone Silva, PhD

CONTACT

919317751; heitor.ivone@gmail.com

Hugo Paredes, PhD

CONTACT

(+351) 259 350 000; hparedes@utad.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Eligible participants will be randomly assigned to three groups in blocks of multiples of five and will be stratified according to i) age; and ii) mean walking distance at the baseline. This procedure will be performed using an online random number generator, by a researcher external to the team involved in the execution of this study, in order to ensure the concealment of the allocation of participants by the different groups. The participants will be blinded as to the group where they were allocated. After this procedure, it will not be possible to hide the group to which the patient belongs from the researcher who will carry out the psychological intervention and from the informatics engineer who will define the route of the walking plan. However, the outcome assessors (doctors, researchers, the clinical physiologist, and the exercise specialist) will be blinded to the allocation group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a single-center three-arm parallel prospective, randomized controlled and superiority trial, with stratified random allocation, aiming to test the effectiveness of a Home-based Exercise Therapy (HbET) for claudicant patients to increase the Maximum Walking Distance (MWD), the Pain-free Walking Distance (PFWD) and the Functional Walking Distance (FWD). Patients will be assigned to one of three groups: an active control group (ACG); an experimental group 1 (GE1) and an experimental group 2 (EG2). All groups will have in common the prescription of a walking plan on a route defined by one of the team members through WalkingPAD web-platform and customized to the patient's home area. Participants from all three groups will undergo standard treatment for PAD and IC, according to the guidelines of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 11, 2021
• Study Start: February 9, 2021
• Primary Completion: October 30, 2022
• Study Completion: November 30, 2023
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)