Clinical trial NCT05126680: Moderate Intensity Functional Training as Adjuvant Treatment in Patients With Peripheral Arterial Disease
Official title: Vascular-Fit: Efficacy of an In-hospital Physical Exercise Program on Functional Capacity and Quality of Life in Patients With Peripheral Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Intermittent Claudication
Keywords: Peripheral arterial disease
Supervised exercise therapy
Functional training
Intermittent claudication
Lead sponsor: European University Miguel de Cervantes
Sponsor class: OTHER
Collaborators: name: Hospital Clínico Universitario de Valladolid
First posted: 2021-11-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Six-Minute Walk Test
timeFrame: 0 weeks, 6 weeks and 12 weeks.
measure: Moderate intensity functional training Test
timeFrame: 0 weeks, 6 weeks and 12 weeks.
measure: Short Form-36 Health Survey (SF-36)
timeFrame: 0 weeks, 6 weeks and 12 weeks.
measure: Vascular Quality of Life Questionnaire-6 (VascuQol-6)
timeFrame: 0 weeks, 6 weeks and 12 weeks.
Secondary outcomes:
measure: Biochemical analysis
timeFrame: 0 weeks, 6 weeks and 12 weeks.
measure: Biochemical analysis
timeFrame: 0 weeks, 6 weeks and 12 weeks.
measure: Biochemical analysis
timeFrame: 0 weeks, 6 weeks and 12 weeks.
measure: Biochemical analysis
timeFrame: 0 weeks, 6 weeks and 12 weeks.
measure: Biochemical analysis
timeFrame: 0 weeks, 6 weeks and 12 weeks.
measure: Biochemical analysis
timeFrame: 0 weeks, 6 weeks and 12 weeks.
measure: Hemodynamic measurements
timeFrame: 0 weeks, 6 weeks and 12 weeks.
measure: Hemodynamic measurements
timeFrame: 0 weeks, 6 weeks and 12 weeks.
measure: Hemodynamic measurements
timeFrame: 0 weeks, 6 weeks and 12 weeks.
measure: Hemodynamic measurements
timeFrame: 0 weeks, 6 weeks and 12 weeks.
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: European University Miguel of Cervantes
Study officials:
References: