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

Not Applicable

Completed

• Conditions: Intermittent Claudication; Peripheral Arterial Disease

• Registration Number: NCT05126680
• Lead Sponsor: European University Miguel de Cervantes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-11-18
• Study Start: 2021-11-19
• Study First Posted: 2021-11-19
• Primary Completion: 2023-04-30
• Study Completion: 2023-06-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Vascular Quality of Life Questionnaire-6 (VascuQol-6)	0 weeks, 6 weeks and 12 weeks.	Changes in total punctuation of questionnaire.
Six-Minute Walk Test	0 weeks, 6 weeks and 12 weeks.	Changes in maximum walking distance (MWD) and claudication onset distance (COD).
Short Form-36 Health Survey (SF-36)	0 weeks, 6 weeks and 12 weeks.	Changes in the eight domains of health status.
Moderate intensity functional training Test	0 weeks, 6 weeks and 12 weeks.	Changes in number of rounds/repetitions and total workload.

Secondary Outcome Measures

Name	Time	Method
Biochemical analysis	0 weeks, 6 weeks and 12 weeks.	Analysis of the complete oxidative profile
Hemodynamic measurements	0 weeks, 6 weeks and 12 weeks.	Changes in pulse wave velocity

Trial Locations

Locations (1)

European University Miguel of Cervantes; 🇪🇸 Valladolid, Spain