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

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

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Intermittent Claudication
• Intervention / Treatment: Other: Supervised exercise therapy: intermittent treadmill walking exercise and moderate intensity functional training; Other: Supervised exercise therapy: intermittent treadmill walking exercise

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valladolid, Spain, 47012
    • European University Miguel of Cervantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intermittent treadmill walking exercise and moderate intensity functional training; 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; 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.
Active Comparator: Intermittent treadmill walking exercise; 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; 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: European University Miguel de Cervantes
• Collaborators: Hospital Clínico Universitario de Valladolid

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2021
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: November 18, 2021
• First Posted (Actual): November 19, 2021

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Peripheral arterial disease; Functional training; Intermittent claudication; Supervised exercise therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
• Other Study ID Numbers: PI-DOC001-PAD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No