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

Primary Purpose

Peripheral Arterial Disease, Intermittent Claudication

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Supervised exercise therapy: intermittent treadmill walking exercise and moderate intensity functional training
Supervised exercise therapy: intermittent treadmill walking exercise
Sponsored by
European University Miguel de Cervantes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Peripheral arterial disease, Supervised exercise therapy, Functional training, Intermittent claudication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • European University Miguel of CervantesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intermittent treadmill walking exercise and moderate intensity functional training

Intermittent treadmill walking exercise

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Biochemical analysis
Changes in complete lipid profile
Biochemical analysis
Changes in lactate dehydrogenase
Biochemical analysis
Changes in c-reactive protein
Biochemical analysis
Changes in tumor necrosis factor alpha
Biochemical analysis
Changes in serum apolipoproteins
Biochemical analysis
Analysis of the complete oxidative profile
Hemodynamic measurements
Changes in mean, systolic and diastolic blood pressure.
Hemodynamic measurements
Changes in flow-mediated dilation of the brachial artery
Hemodynamic measurements
Changes in ankle-brachial index
Hemodynamic measurements
Changes in pulse wave velocity

Full Information

First Posted
November 8, 2021
Last Updated
November 18, 2021
Sponsor
European University Miguel de Cervantes
Collaborators
Hospital Clínico Universitario de Valladolid
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1. Study Identification

Unique Protocol Identification Number
NCT05126680
Brief Title
Moderate Intensity Functional Training as Adjuvant Treatment in Patients With Peripheral Arterial Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 19, 2021 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European University Miguel de Cervantes
Collaborators
Hospital Clínico Universitario de Valladolid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Intermittent Claudication
Keywords
Peripheral arterial disease, Supervised exercise therapy, Functional training, Intermittent claudication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intermittent treadmill walking exercise and moderate intensity functional training
Arm Type
Experimental
Arm Description
Subjects belonging to this group perform a 12-week supervised exercise therapy consisted of intermittent treadmill walking exercise and moderate intensity functional training.
Arm Title
Intermittent treadmill walking exercise
Arm Type
Active Comparator
Arm Description
Subjects belonging to this group perform a 12-week supervised exercise therapy consisted of intermittent treadmill walking exercise.
Intervention Type
Other
Intervention Name(s)
Supervised exercise therapy: intermittent treadmill walking exercise and moderate intensity functional training
Intervention Description
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
Intervention Name(s)
Supervised exercise therapy: intermittent treadmill walking exercise
Intervention Description
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 Outcome Measure Information:
Title
Six-Minute Walk Test
Description
Changes in maximum walking distance (MWD) and claudication onset distance (COD).
Time Frame
0 weeks, 6 weeks and 12 weeks.
Title
Moderate intensity functional training Test
Description
Changes in number of rounds/repetitions and total workload.
Time Frame
0 weeks, 6 weeks and 12 weeks.
Title
Short Form-36 Health Survey (SF-36)
Description
Changes in the eight domains of health status.
Time Frame
0 weeks, 6 weeks and 12 weeks.
Title
Vascular Quality of Life Questionnaire-6 (VascuQol-6)
Description
Changes in total punctuation of questionnaire.
Time Frame
0 weeks, 6 weeks and 12 weeks.
Secondary Outcome Measure Information:
Title
Biochemical analysis
Description
Changes in complete lipid profile
Time Frame
0 weeks, 6 weeks and 12 weeks.
Title
Biochemical analysis
Description
Changes in lactate dehydrogenase
Time Frame
0 weeks, 6 weeks and 12 weeks.
Title
Biochemical analysis
Description
Changes in c-reactive protein
Time Frame
0 weeks, 6 weeks and 12 weeks.
Title
Biochemical analysis
Description
Changes in tumor necrosis factor alpha
Time Frame
0 weeks, 6 weeks and 12 weeks.
Title
Biochemical analysis
Description
Changes in serum apolipoproteins
Time Frame
0 weeks, 6 weeks and 12 weeks.
Title
Biochemical analysis
Description
Analysis of the complete oxidative profile
Time Frame
0 weeks, 6 weeks and 12 weeks.
Title
Hemodynamic measurements
Description
Changes in mean, systolic and diastolic blood pressure.
Time Frame
0 weeks, 6 weeks and 12 weeks.
Title
Hemodynamic measurements
Description
Changes in flow-mediated dilation of the brachial artery
Time Frame
0 weeks, 6 weeks and 12 weeks.
Title
Hemodynamic measurements
Description
Changes in ankle-brachial index
Time Frame
0 weeks, 6 weeks and 12 weeks.
Title
Hemodynamic measurements
Description
Changes in pulse wave velocity
Time Frame
0 weeks, 6 weeks and 12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Saúl Peñín-Grandes, MsC
Phone
+34983001000
Email
saulpenin@gmail.com
Facility Information:
Facility Name
European University Miguel of Cervantes
City
Valladolid
ZIP/Postal Code
47012
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saúl Peñín-Grandes, MsC
Phone
+34983001000
Email
saulpenin@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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