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

NCT ID: NCT05126680

Last Updated: 2024-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-19

Study Completion Date

2023-06-30

Brief Summary

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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

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Conditions

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Peripheral Arterial Disease Intermittent Claudication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Intermittent treadmill walking exercise

Subjects belonging to this group perform a 12-week supervised exercise therapy consisted of intermittent treadmill walking exercise.

Group Type ACTIVE_COMPARATOR

Supervised exercise therapy: intermittent treadmill walking exercise

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital ClĂ­nico Universitario de Valladolid

OTHER

Sponsor Role collaborator

European University Miguel de Cervantes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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European University Miguel of Cervantes

Valladolid, , Spain

Site Status

Countries

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Spain

References

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Penin-Grandes S, Lopez-Ortiz S, de la Fuente Gomez M, Pinto-Fraga J, Lista S, Maroto-Izquierdo S, Lucia A, Del Rio Sola ML, Martin-Hernandez J, Santos-Lozano A. Move Better, Live Better: A Novel Supervised Combined Training for Peripheral Arterial Disease: A Quasi-experimental Approach. Am J Phys Med Rehabil. 2025 Sep 1;104(9):771-779. doi: 10.1097/PHM.0000000000002706. Epub 2025 Jan 6.

Reference Type DERIVED
PMID: 39792377 (View on PubMed)

Other Identifiers

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PI-DOC001-PAD

Identifier Type: -

Identifier Source: org_study_id

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