Skip to main content
OpenTrials
Completed

NCT Number: NCT05126680

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Intermittent Claudication Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

European University Miguel of Cervantes

Valladolid, 47012, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supervised exercise therapy: intermittent treadmill walking exercise and moderate intensity functional training

Other

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.

Supervised exercise therapy: intermittent treadmill walking exercise

Other

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.

Primary outcomes

  1. Six-Minute Walk Test

    Time frame: 0 weeks, 6 weeks and 12 weeks.

    Changes in maximum walking distance (MWD) and claudication onset distance (COD).

  2. Moderate intensity functional training Test

    Time frame: 0 weeks, 6 weeks and 12 weeks.

    Changes in number of rounds/repetitions and total workload.

  3. Short Form-36 Health Survey (SF-36)

    Time frame: 0 weeks, 6 weeks and 12 weeks.

    Changes in the eight domains of health status.

  4. Vascular Quality of Life Questionnaire-6 (VascuQol-6)

    Time frame: 0 weeks, 6 weeks and 12 weeks.

    Changes in total punctuation of questionnaire.

Secondary outcomes

  1. Biochemical analysis

    Time frame: 0 weeks, 6 weeks and 12 weeks.

    Changes in complete lipid profile

  2. Biochemical analysis

    Time frame: 0 weeks, 6 weeks and 12 weeks.

    Changes in lactate dehydrogenase

  3. Biochemical analysis

    Time frame: 0 weeks, 6 weeks and 12 weeks.

    Changes in c-reactive protein

  4. Biochemical analysis

    Time frame: 0 weeks, 6 weeks and 12 weeks.

    Changes in tumor necrosis factor alpha

  5. Biochemical analysis

    Time frame: 0 weeks, 6 weeks and 12 weeks.

    Changes in serum apolipoproteins

  6. Biochemical analysis

    Time frame: 0 weeks, 6 weeks and 12 weeks.

    Analysis of the complete oxidative profile

  7. Hemodynamic measurements

    Time frame: 0 weeks, 6 weeks and 12 weeks.

    Changes in mean, systolic and diastolic blood pressure.

  8. Hemodynamic measurements

    Time frame: 0 weeks, 6 weeks and 12 weeks.

    Changes in flow-mediated dilation of the brachial artery

  9. Hemodynamic measurements

    Time frame: 0 weeks, 6 weeks and 12 weeks.

    Changes in ankle-brachial index

  10. Hemodynamic measurements

    Time frame: 0 weeks, 6 weeks and 12 weeks.

    Changes in pulse wave velocity

Sponsors and collaborators

Lead sponsor

European University Miguel de Cervantes

Other

Collaborators

  • Hospital Clínico Universitario de Valladolid

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 19, 2021
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.