Moderate Intensity Functional Training as Adjuvant Treatment in Patients With Peripheral Arterial Disease

Study Overview
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Brief Summary
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Traditional aerobic training and muscle resistance ('strength') training have been shown to be effective for improving functional and health-related quality of life (HRQoL) outcomes in peripheral arterial disease (PAD). However, the transfer of the current resistance exercise modes proposed to other activities of daily living (ADLs) is questionable. Moderate intensity functional training (MIFT) has emerged with the aim of achieving cardiovascular and neuromuscular adaptations simultaneously with functional exercises typical of ADLs. The effect of MIFT in patients with PAD is not yet known. Our purpose is to verify the influence of the combination of intermittent treadmill walking exercise with MIFT compared with intermittent treadmill walking exercise on functional capacity, HRQoL, biochemical and hemodynamic parameters in patients with PAD.

Official Title
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Vascular-Fit: Efficacy of an In-hospital Physical Exercise Program on Functional Capacity and Quality of Life in Patients With Peripheral Artery Disease

Conditions
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Peripheral Arterial Disease, Intermittent Claudication

Intervention / Treatment
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* Other: Supervised exercise therapy: intermittent treadmill walking exercise and moderate intensity functional training
* Other: Supervised exercise therapy: intermittent treadmill walking exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with PAD in grade IIa (Leriche-Fontaine Classification). Exclusion Criteria: Subjects with dementia. Institutionalized Subjects in social health centers. Subjects with recent major surgery in the last year or lower limb amputations. Subjects with revascularization surgery of the lower extremities.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intermittent treadmill walking exercise and moderate intensity functional training<br>Subjects belonging to this group perform a 12-week supervised exercise therapy consisted of intermittent treadmill walking exercise and moderate intensity functional training. | Other: Supervised exercise therapy: intermittent treadmill walking exercise and moderate intensity functional training<br>* Subjects will perform a 12-week supervised exercise therapy program based on intermittent treadmill walking exercise (15-30 min.) and moderate intensity functional training (MIFT) (15 min.). In intermittent treadmill walking exercise, the speed and incline of treadmill will be adjusted that patients achieve moderate claudication pain in the time interval between 3 and 5 min. In MIFT, subjects must complete in 15 min. the highest number of repetitions / rounds possible (AMRAP) to a circuit composed of 6 global functional exercises from which they performed 10 repetitions with a rating of perceived exertion (RPE) of 5-7 on a 1 to 10 scale in each exercise.<br>|
| Active Comparator: Intermittent treadmill walking exercise<br>Subjects belonging to this group perform a 12-week supervised exercise therapy consisted of intermittent treadmill walking exercise. | Other: Supervised exercise therapy: intermittent treadmill walking exercise<br>* Subjects will perform a 12-week supervised exercise therapy program based on intermittent treadmill walking exercise (30-45 min.). In intermittent treadmill walking exercise, the speed and incline of treadmill will be adjusted that patients achieve moderate claudication pain in the time interval between 3 and 5 min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-Minute Walk Test | Changes in maximum walking distance (MWD) and claudication onset distance (COD). | 0 weeks, 6 weeks and 12 weeks. | 
| Moderate intensity functional training Test | Changes in number of rounds/repetitions and total workload. | 0 weeks, 6 weeks and 12 weeks. | 
| Short Form-36 Health Survey (SF-36) | Changes in the eight domains of health status. | 0 weeks, 6 weeks and 12 weeks. | 
| Vascular Quality of Life Questionnaire-6 (VascuQol-6) | Changes in total punctuation of questionnaire. | 0 weeks, 6 weeks and 12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical analysis | Changes in complete lipid profile | 0 weeks, 6 weeks and 12 weeks. | 
| Biochemical analysis | Changes in lactate dehydrogenase | 0 weeks, 6 weeks and 12 weeks. | 
| Biochemical analysis | Changes in c-reactive protein | 0 weeks, 6 weeks and 12 weeks. | 
| Biochemical analysis | Changes in tumor necrosis factor alpha | 0 weeks, 6 weeks and 12 weeks. | 
| Biochemical analysis | Changes in serum apolipoproteins | 0 weeks, 6 weeks and 12 weeks. | 
| Biochemical analysis | Analysis of the complete oxidative profile | 0 weeks, 6 weeks and 12 weeks. | 
| Hemodynamic measurements | Changes in mean, systolic and diastolic blood pressure. | 0 weeks, 6 weeks and 12 weeks. | 
| Hemodynamic measurements | Changes in flow-mediated dilation of the brachial artery | 0 weeks, 6 weeks and 12 weeks. | 
| Hemodynamic measurements | Changes in ankle-brachial index | 0 weeks, 6 weeks and 12 weeks. | 
| Hemodynamic measurements | Changes in pulse wave velocity | 0 weeks, 6 weeks and 12 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral arterial disease, Supervised exercise therapy, Functional training, Intermittent claudication