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

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05126680
• Other study ID #: PI-DOC001-PAD
• Status: Completed
• Phase: N/A
• Start date: November 19, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2024
• Source: European University Miguel de Cervantes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	European University Miguel of Cervantes	Valladolid

Sponsors (2)

Lead Sponsor	Collaborator
European University Miguel de Cervantes	Hospital Clínico Universitario de Valladolid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six-Minute Walk Test	Changes in maximum walking distance (MWD) and claudication onset distance (COD).	0 weeks, 6 weeks and 12 weeks.
Primary	Moderate intensity functional training Test	Changes in number of rounds/repetitions and total workload.	0 weeks, 6 weeks and 12 weeks.
Primary	Short Form-36 Health Survey (SF-36)	Changes in the eight domains of health status.	0 weeks, 6 weeks and 12 weeks.
Primary	Vascular Quality of Life Questionnaire-6 (VascuQol-6)	Changes in total punctuation of questionnaire.	0 weeks, 6 weeks and 12 weeks.
Secondary	Biochemical analysis	Changes in complete lipid profile	0 weeks, 6 weeks and 12 weeks.
Secondary	Biochemical analysis	Changes in lactate dehydrogenase	0 weeks, 6 weeks and 12 weeks.
Secondary	Biochemical analysis	Changes in c-reactive protein	0 weeks, 6 weeks and 12 weeks.
Secondary	Biochemical analysis	Changes in tumor necrosis factor alpha	0 weeks, 6 weeks and 12 weeks.
Secondary	Biochemical analysis	Changes in serum apolipoproteins	0 weeks, 6 weeks and 12 weeks.
Secondary	Biochemical analysis	Analysis of the complete oxidative profile	0 weeks, 6 weeks and 12 weeks.
Secondary	Hemodynamic measurements	Changes in mean, systolic and diastolic blood pressure.	0 weeks, 6 weeks and 12 weeks.
Secondary	Hemodynamic measurements	Changes in flow-mediated dilation of the brachial artery	0 weeks, 6 weeks and 12 weeks.
Secondary	Hemodynamic measurements	Changes in ankle-brachial index	0 weeks, 6 weeks and 12 weeks.
Secondary	Hemodynamic measurements	Changes in pulse wave velocity	0 weeks, 6 weeks and 12 weeks.