Intermittent Claudication, Peripheral Arterial Disease
Conditions
Keywords
Peripheral arterial disease, Supervised exercise therapy, Functional training, Intermittent claudication
Brief summary
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.
Interventions
OTHERSupervised exercise therapy: intermittent treadmill walking exercise and moderate intensity functional training
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.
OTHERSupervised exercise therapy: intermittent treadmill walking exercise
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.
Sponsors
Hospital Clínico Universitario de Valladolid
European University Miguel de Cervantes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six-Minute Walk Test | 0 weeks, 6 weeks and 12 weeks. | Changes in maximum walking distance (MWD) and claudication onset distance (COD). |
| Moderate intensity functional training Test | 0 weeks, 6 weeks and 12 weeks. | Changes in number of rounds/repetitions and total workload. |
| Short Form-36 Health Survey (SF-36) | 0 weeks, 6 weeks and 12 weeks. | Changes in the eight domains of health status. |
| Vascular Quality of Life Questionnaire-6 (VascuQol-6) | 0 weeks, 6 weeks and 12 weeks. | Changes in total punctuation of questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical analysis | 0 weeks, 6 weeks and 12 weeks. | Changes in complete lipid profile |
| Hemodynamic measurements | 0 weeks, 6 weeks and 12 weeks. | Changes in mean, systolic and diastolic blood pressure. |
Countries
Spain
Outcome results
None listed