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Peripheral Arterial Disease (PAD)
+1

Home-based Exercise Therapy for Patients With PAD

Sponsored by Centro Hospitalar do Porto

About this trial

Last updated 2 years ago

Study ID

069-DEFI/068-CES

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
50 to 80 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended a year ago

What is this trial about?

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?

What are the participation requirements?

Yes

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;

No

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);

Locations

Location

Status

Recruiting