Home-based Exercise Therapy for Patients With PAD

NCT ID: NCT04749732

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-09
• Study Completion Date: 2023-11-30

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?

Detailed Description

Exercise training has been incorporated into current guidelines for the management of PAD. Multiple societal guidelines, including the American Heart Association Task Force on Clinical Practice Guidelines, Intersociety Consensus for the Management of PAD (TASC II), recommend supervised exercise therapy (SET) in the treatment of claudication symptoms in PAD. Consequently, the European Society of Cardiology proposes walking training as first-step therapy for claudicant patients before percutaneous or surgical options. Therefore, SET is the gold-standard for walking therapy in PAD patients. Although SET programs have proved to be more effective in increasing Maximum Walking Distance (MWD) and Pain-free Walking Distance (PFWD) compared with non-supervised exercise programs, they remain an underutilized tool and widespread implementation of SET is restricted by lack of facilities and funding. Home-based Exercise Therapy (HBET) has the advantage of providing a larger capacity of care, and in most cases, being feasibly close to the patients' home environment with reduced transport costs. Programs are self-directed with the guidance of healthcare providers that prescribe an exercise regimen similar to a supervised program. Thus, the primary goal of this study is to evaluate the effectiveness of an HBET program in increasing MWD, PFWD, and Functional Walking Distance (FWD). The study's primary outcomes will be MWD, PFWD, and FWD; secondary outcomes will be general and PAD-specific health-related quality of life (HRQoL) measures. A web platform and a mobile app will be created - WalkingPAD platform and app- allowing collaboration between several players, enhancing patient's compliance and accountability in their treatment strategy. Thus, an HBET will be prescribed to all the patients included in the study. The exercise prescription consists of: walking as the form of exercise, with a duration greater than 30 min per session, frequency of at least three sessions per week, using a near-maximal pain during training as claudication pain endpoint, and with a 6-month of duration. Participants will be randomized by three conditions - Active Control Group (ACG), an Experimental Group 1 (EG1), and an Experimental Group 2 (EG2) - stratified by age and MWD at baseline, and assessed at Time 1 (T1: before intervention), three months later (T2), and six months later (T3; follow-up). With WalkingPAD, investigators intend to demonstrate the technical feasibility and economic viability of a personalized medicine application in real-life healthcare settings and aspire to ensure coordination with national, regional, or local health authorities for dissemination and implementation of a new patient-centered, effective and low-cost therapeutic strategy.

Sample size calculation:

A total of 200 PAD patients with IC are expected to be recruited from the outpatient clinic of the Angiology & Vascular Surgery Department in CHUP-HSA in an attempt to account for the dropout rate and still achieve a large enough sample to obtain a 95% confidence interval. The minimum sample size of the total computerized sample for the 2 repeated measures (baseline and 3 months; and baseline and 6 months) was 54 participants, i.e. a minimum of 27 participants in each group (interventions groups and control group). The sample size was calculated for an effect size of 0.25, alfa of 0.05 and a power of 0,95 (1-beta) by the G*Power software.

Data Analysis:

Analyses of primary and secondary outcomes and process variables will be conducted on an intention-to-treat basis and all included participants will be analyzed as randomized.

Procedure:

Patients with PAD and IC, evaluated in the outpatient clinic of the Angiology & Vascular Surgery Department of CHUP-HSA between January and December of 2020 will be contacted by phone and invited to participate in the study. After obtaining oral consent by phone, a clinical, physical, hemodynamic and psychological evaluation will be scheduled at the hospital - Time 0 (T0 before assignment). In this assessment (T0), participants will sign a written consent and will be screened (1 hour +/-) to ascertain particular and specific exclusion and inclusion criteria.

Then, block randomization with four stratum will be performed. Stratum will be defined by age and mean walking distance at baseline. All patients will be informed of the goals, experimental procedures, risks, and benefits of the study. Signed informed consent from all patients will be obtained confirming adequate understanding of all information, voluntary decision and free from undue influence such as manipulation or coercion. The right of the recruited participants to change their minds and to abandon the investigation without penalty and with no obligation to justify shall be respected. All participants will have access to information about the new knowledge generated by the research to which they contributed. The privacy and confidentiality of patients' clinical data and respect for autonomy will be guaranteed. At Time 1 (T1), patients who meet the inclusion criteria (at T0) and accept to collaborate in this study will be (blind) allocated to one of the study's arms - ACG, EG1, or EG2, and evaluated with psychological and physical measures. Patients will be assessed after 3 months (T2) and six months (T3).

Conditions

Peripheral Arterial Disease (PAD); Intermittent Claudication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

WalkingPad plus Psychological Intervention - PsyWPad Group

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.

Group Type: EXPERIMENTAL

WalkingPad plus Psychological Intervention - PsyWPad Group

Intervention Type: 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.

WalkingPad plus Virtual Assistant - CyberWPad Group

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.

Group Type: EXPERIMENTAL

WalkingPad plus Virtual Assistant - CyberWPad Group

Intervention Type: 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.

Paper WalkingPad group - PaperWPad Group

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.

Group Type: ACTIVE_COMPARATOR

WalkingPad group - Paper WPad Group

Intervention Type: 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.

Interventions

WalkingPad plus Psychological Intervention - PsyWPad Group

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.

Intervention Type: BEHAVIORAL

WalkingPad plus Virtual Assistant - CyberWPad Group

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.

Intervention Type: BEHAVIORAL

WalkingPad group - Paper WPad Group

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Behavioral Change; Behavioral Change; Behavioral Change

Eligibility Criteria

Inclusion Criteria

1. PAD with IC (Fontaine II ou Rutherford 1-3) due to atherosclerotic disease;

2. ABI below 0.9 at rest or below 0.73 after exercise (20% decrease);

3. Age range between 50 and 80;

4. MWD in treadmill test between 50 and 500 meters;

Exclusion Criteria

1. Asymptomatic PAD;

2. Critical Ischemia (Fontaine III/IV or Rutherford 4-6);

3. Previous lower extremity vascular surgery, angioplasty, or lumbar sympathectomy;

4. Any condition other than PAD that limits walking;

5. Miocardial Infarction or Unstable Angina in the last 6 months;

6. Inability to obtain ABI measure because of non-compressible vessels;

7. Use of cilostazol and pentoxifylline initiated within 3 months before the investigation;

8. Active cancer, renal disease, or liver disease;

9. Severe chronic obstructive pulmonary disease (GOLD stage III/IV);

10. Severe congestive heart failure (NYHA class III/IV);

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation for Science and Technology, Portugal

OTHER

Sponsor Role: collaborator

University of Trás-os-Montes and Alto Douro

OTHER

Sponsor Role: collaborator

Institute for Systems and Computer Engineering, Technology and Science-INESC TEC

UNKNOWN

Sponsor Role: collaborator

Centro Hospitalar do Porto

OTHER

Sponsor Role: lead

Responsible Party

Ivone Silva

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ivone Heitor, PhD

Role: PRINCIPAL_INVESTIGATOR

Centro Hospitalar do Porto

Locations

Centro Hospitalar do Porto

Porto, , Portugal

Site Status: RECRUITING

Countries

Portugal

Central Contacts

Ivone Silva, PhD

Role: CONTACT

heitor.ivone@gmail.com

919317751

Hugo Paredes, PhD

Role: CONTACT

hparedes@utad.pt

(+351) 259 350 000 ext. 4786

Facility Contacts

Ivone Silva, PhD

Role: primary

heitor.ivone@gmail.com

(+351) 22 207 7500

Hugo Paredes, PhD

Role: backup

hparedes@utad.pt

(+351) 259 350 000 ext. 4786

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PMID: 35436974 (View on PubMed)

Other Identifiers

069-DEFI/068-CES

Identifier Type: -

Identifier Source: org_study_id