Home-based Exercise Therapy for Patients With PAD

Intermittent Claudication Clinical Trial

— WalkingPAD  

Official title:

Patient Education on a Quantified Supervised Home-based Exercise Therapy to Improve Walking Ability in Patients With Peripheral Arterial Disease and Intermittent Claudication: WalkingPad Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04749732
• Other study ID #: 069-DEFI/068-CES
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: February 2023
• Source: Centro Hospitalar do Porto
• Contact: Ivone Silva, PhD
• Phone: 919317751
• Email: heitor.ivone[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 30, 2023
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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);

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Arterial Disease (PAD)
• Peripheral Vascular Diseases

Intervention

Behavioral:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Portugal	Centro Hospitalar do Porto	Porto

Sponsors (4)

Lead Sponsor	Collaborator
Centro Hospitalar do Porto	Foundation for Science and Technology, Portugal, Institute for Systems and Computer Engineering, Technology and Science-INESC TEC, University of Trás-os-Montes and Alto Douro

Country where clinical trial is conducted

Portugal, 

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sociodemographic Data	The following socio-demographic data will be collected: gender; age; living environment; marital status; professional status; rural or urban areas of residence.	T0 (before-assignment)
Other	Clinical Data	The clinical data to collect will be: medical history, surgical history, chronic medication, lifestyle habits (alcohol and tobacco consumption, hours of sleep, and the number of meals per day).	T1 (before intervention) to T2 (3 months), and to T3 (six-months)
Other	Ankle-brachial-index (ABI)	The ABI measures the systolic pressures at the brachial artery, anterior tibial artery, and posterior tibial artery in the supine position in millimeters of mercury (mmHg), and will be assessed through a validated and certified Doppler device.	T1 (before intervention) to T2 (3 months), and to T3 (six-months)
Other	Transcutaneous Oxygen Pressure (TcPO2)	TcPO2 measures limb ischemia in millimeters of mercury (mmHg), and will be assessed through a validated and certified TcPO2 patient monitor.	T1 (before intervention) to T2 (3 months), and to T3 (six-months)
Other	Hand Strength	HGS measures and determines musculoskeletal function, weakness and disability in kilograms (kg), through a hand-held dynamometer.	T1 (before intervention) to T2 (3 months), and to T3 (six-months)
Other	Weight	Weight will be mesured in kilograms (kg), through a bioimpedance scale.	T1 (before intervention) to T2 (3 months), and to T3 (six-months)
Other	Height	Height will be measured in Meters (mts), using a tape measure.	[Time Frame: Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months)]
Other	Body Mass Index	Body mass index (kg/m2) will be measured through a bioimpedance scale.	[Time Frame: Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months)]
Other	Resting metabolism	Resting metabolism of the patient will be measured in kilocalories (kcal) through a bioimpedance scale.	[Time Frame: Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months)]
Other	Body fat percentage	Body fat percentage (%) will be measured through a bioimpedance scale.	[Time Frame: Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months)]
Other	Visceral fat level	Visceral fat level (%) will be measured through a bioimpedance scale.	[Time Frame: Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months)]
Other	Skeletal muscle percentage	Skeletal muscle percentage (%) will be measured through a bioimpedance scale.	[Time Frame: Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months)]
Other	Mental State	Mental state will be measured through the Mini-Mental State Examination (MMSE). This is a widely used test of cognitive function among the elderly, including tests of orientation, attention, memory, language, and visual-spatial skills. Higher results correspond to a better mental state.	T0 (before-assignment)
Other	Physical Performance	Change in Physical performance will be measured through the International Physical Activity Questionnaire for the elderly (IPAQ_E) assesses self-reported moderate-to-vigorous physical activity (MVPA) and sedentary behavior (SB) in older adults, with scores ranging from 0 to indefinite minutes of physical activity per week and higher results correspond to a greater amount of physical activity performed. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity.	Changes from T0 (before-assignment) to T2 (3 months), and to T3 (six-months)
Other	Anxiety Symptoms	Anxiety symptoms will be measured through the Geriatric Anxiety Scale (GAS) assesses anxiety symptoms in older adults, with scores ranging from 0 to 5 and higher results correspond to more anxiety symptoms.	Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months)
Other	Depression Symptoms	Depression symptoms will be measured through the Geriatric Depression Scale-5 (GDS) assesses depressive symptoms in older adults, with scores ranging from 0 to 5 and higher results correspond to more depression symptoms.	[Time Frame: Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months)]
Other	Stage of Change	The Stage of Change will be measured through the Walking Motivation/Readiness for Change Questionnaire (WM/RCQ) which identifies the Stage of Change (SOC) in which participants are at the moment regarding walking training (Pre-contemplation, Contemplation, Preparation, Action, and Maintenance). Participants can only be in one stadium so the answer is exclusive to a single stadium (yes = 1; no = 0).	Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months)
Other	Locus of Causality	Locus of causality will be measured through the Locus of Causality for Exercise Scale (LCES). This scale assesses the extent to which individuals feel that they freely choose to exercise rather than feeling that they have to for some reason. The response scale ranges from 3 to 18. Higher results indicate higher levels of autonomy (locus of causality internal).	Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months)
Other	Walking Planned Behavior	Planned behavior will be assessed through the Walking Planned Behavior Questionnaire (WPBQ), which assesses intentions, attitudes, subjective norms, action and coping plans regarding walking. The response scale of ranges from 3 to 18. On the intentions scale, the score ranges between 2 and 10 points and higher scores indicate higher intention in do physical activity (walking); On the attitudes scale, the score ranges between 5 and 25 points and higher scores indicate a more positive the attitudes towards physical activity; On the subjective norms scale, the score ranges between 3 and 15 points, in which the higher the score, the higher is the perception of the importance attributed by other people to physical activity.	Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months)
Other	Illness representations	Representations regarding PAD will be measured through the Illness Perception Questionnaire - Brief (IPQ-B). This assesses illness perceptions, with a response scale ranging from 0 to 10. Higher scores indicate more threatening perceptions regarding PAD.	Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months)
Other	Basic Psychological Need Satisfaction	Basic Psychological Need Satisfaction will be assessed through the Psychological Need Satisfaction in Exercise Scale (PNSES). This scale assesses perceived psychological need satisfaction of the three basic psychological needs in the context of exercise (walking training): autonomy, competence, and positive relationship (relatedness). The response scale ranges from 12 to 60. Higher scores indicate more perceptions of psychological need fulfilment in exercise (walking).	Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months)
Other	Behavioral Regulation	Regulation in Exercise will be measured through the Behavioral Regulation in Exercise Questionnaire (BREQ-3). This scale assesses the motivational regulations for walking training and the response scale ranges from 0 to 12 for each type of regulation. Higher results indicate higher levels of one of the following types of behavioral regulation: amotivation, external, introjected, identified, integrated, and intrinsic.	Changes from T1 (baseline) to T2 (3 months), and to T3 (six-months)
Other	Cost-effectiveness of home-based exercise Vs. clinical-base exercise	Compare cost-effectiveness analysis of HBET Control Vs. HBET with motivational support Vs. HBET with a virtual assistant. The outcome measure will be cost per quality adjusted life year (QALY)	At 6 months
Primary	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)
Primary	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)
Primary	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	Physical Quality of Life	Physical Quality of Life will be assessed through the Short-Form Health Survey (SF-36). Raw scores are transformed into a scale from 0 to 100. Higher results correspond to better physical quality of life. Higher results correspond to a better physical quality of life.	Changes from T0 (before-assignment) to T2 (3 months), and to T3 (six-months)
Secondary	Mental Quality of Life	Mental Quality of Life will be assessed through the Short-Form Health Survey (SF-36). Raw scores are transformed into a scale from 0 to 100. Higher results correspond to better mental quality of life. Higher results correspond to a better mental quality of life.	Changes from T0 (before-assignment) to T2 (3 months), and to T3 (six-months)
Secondary	Vascular Disease specific Quality of Life	Vascular disease-specific quality of Life will be assessed through the Vascular Disease-specific Quality of Life (VAsQoL-6). This is a specific measure for patients with PAD, assessing health-related quality of life in PAD. Scores range between 6 and 24, with higher results corresponding to a better quality of life associated with vascular disease.	Changes from T0 (before-assignment) to T2 (3 months), and to T3 (six-months)
Secondary	Walking Impairment	Walking impairment will be assessed through the Walking Impairment Questionnaire (WIQ) that assesses walking abilities in three domains: distance (distances that the individual can walk) with scores ranging between 0 and 28, with higher results corresponding to greater distance; speed (the speed that the individual can walk) with scores ranging between 0 and 16, with higher results corresponding to greater speed; stairs (number of stairs that the individual can climb) with scores ranging between 0 and 12, with higher results corresponding to greater ability to climb stairs;	Changes from T0 (before-assignment) to T2 (3 months), and to T3 (six-months)