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High-intensity Intervals Versus Low-to-moderate-intensity Exercise Training in Patients With PAD (HIIT_PAD)

Primary Purpose

Peripheral Arterial Disease

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
High-intensity interval training group (HIIT)
Low-to-moderate intensity training group (LowMod group)
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Exercise, Rehabilitation, Physical activity

Eligibility Criteria

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

Inclusion Criteria: Adult patients with symptomatic PAD (Fontaine stage IIa/b); ABI ≤ 0.9 or drop by 20% following exercise treadmill test 1; TBI ≤ 0.6 if incompressible arteries (diabetes and renal insufficiency); Signed written informed consent form. Exclusion Criteria: Age < 18; Unable to walk at 3.2 km/h on a treadmill (slope 0%) at least 300 m; Previous participate in SET programs ≤ 1 year; Prior leg/foot amputation; Contraindication to exercise Neurological and neuromuscular disorders and other comorbidities (orthopedic, rheumatologic) leading to gait abnormalities. Known Pregnancy Incapacity of discernment

Sites / Locations

  • CHUVRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High-intensity interval training group (HIIT)

Low-to-moderate intensity training group (LowMod group)

Arm Description

Exercise training sessions will consist in an alternation of brief periods (≤ 60 s) of work performed at high intensity and brief period of passive rest. Patient will be asked to complete 1 set of 10-15x60-s (or 2 sets of 5-7x60-s) walking intervals. This protocol will elicits moderate-to-severe claudication pain during exertion. The training intensity in the HIIT group will be set at ≥85% HRpeak recorded during the maximal cardiopulmonary exercise test.

Exercise training sessions will consist in an alternation of periods of work performed at moderate exercise intensity and period of passive rest. The training approach of the LowMod group will be similar to the training prescription usually adopted in patients with claudication. The exercise training intensity will be set at ≤76% HRpeak recorded during the maximal cardiopulmonary exercise test.

Outcomes

Primary Outcome Measures

Walking performance
Patients will perform an incremental treadmill test to determine the pain-free (PFWD) and maximal walking distance (MWD). Initial walking speed will be set at 3.2 km/h, and at 0% grade. The grade will be increased by 2% each 2 min.

Secondary Outcome Measures

Functional walking performance
Patients will perform a 6-minute walk test
Cardiorespiratory fitness (VO2peak)
Patients will perform a maximal cardiopulmonary exercise test
Lower limb functional performance
Patients will perform a stair climbing test, 30-s repeated sit-to-stand chair test, short physical performance battery test (SPPB), and 15 meters walking test
Spatiotemporal gait and foot kinematics parameters
Spatiotemporal gait and foot kinematics parameters will be assessed during the 6-minute walking tests and during the 15 meters walking test
Muscle oxygenation during treadmill test
Muscle oxygenation will be assessed during treadmill test by near-infrared spectroscopy (NIRS)
Vascular parameters
Ankle - toe brachial index (ABI, TBI)
Self-perceived quality of life and walking (dis)abilities
Self-perceived quality of life (Medical Outcomes Study Short-Form 36 (SF-36) and walking (dis)abilities (Walking Impairement Questionnaire, WIQ) will be assessed. Each questionnaire has scores on a 0-100 scale (0 (worse score) to 100 (best score)).
Total amount of physical activity
The total amount of physical activity will be assessed by accelerometer

Full Information

First Posted
October 31, 2022
Last Updated
August 16, 2023
Sponsor
Centre Hospitalier Universitaire Vaudois
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1. Study Identification

Unique Protocol Identification Number
NCT05612945
Brief Title
High-intensity Intervals Versus Low-to-moderate-intensity Exercise Training in Patients With PAD
Acronym
HIIT_PAD
Official Title
Short-duration Aerobic High-intensity Intervals Versus Low-to-moderate-intensity Exercise Training in Symptomatic Patients With Peripheral Artery Disease: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
January 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois

4. Oversight

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

5. Study Description

Brief Summary
Supervised exercise training (SET) is considered among first-line therapies for patients with symptomatic lower extremity peripheral artery disease (PAD), combined with general cardiovascular risk management, lifestyle adaptation and pharmacological treatment. Although without clear consistency, the guidelines give recommendations in terms of claudication pain severity, SET volume, duration, and frequency. However, no or little guidance is offered as far as training intensity is concerned. Most of the previous studies on SET, in the context of PAD, did not distinguish between symptom intensity and common training intensity measures such as % of maximal heart rate (%HRmax), % of HR reserve (%HRR), % of peak oxygen uptake (%VO2peak), % of VO2 reserve (%VO2R), or the rate of perceived exertion (RPE). In a recent meta-analysis, we demonstrated that both training modality and exercise intensity (based on %peak heart rate, %peak oxygen uptake, or the rate of perceived exertion) should be considered when looking for the best results in patients with symptomatic PAD. These results call for study of the individual roles of each exercise intensity and modality on walking performance and cardiorespiratory fitness in patients with symptomatic PAD. High-intensity interval training (HIIT) is composed of brief bursts of vigorous intensity interspersed with periods of rest or low-intensity exercise. HIIT may be better than moderate-intensity training (MIT) in improving cardiorespiratory fitness and functional capacity in patients with cardiovascular and metabolic diseases, but in patients with symptomatic PAD, the effects of such modalities on walking ability and cardiorespiratory fitness remain to be clearly determined. The primary objective of this study is to compare the effects of 12-week-long exercise training (short-duration high-intensity intervals vs. low-to-moderate intensity) on treadmill performance in patients with symptomatic PAD. It is hypothesized that treadmill performance would be improved to a greater extent after high-intensity exercise training
Detailed Description
Lower extremity peripheral artery disease (PAD) affects more than 200 million people worldwide. PAD is characterized by atherosclerotic lumen narrowing or occlusion of the lower limb arteries, leading to an imbalance between oxygen supply and demand downstream, especially in activated muscle during exertion. The hallmark symptom of PAD is typical intermittent claudication, defined as reproducible exertion-induced cramping or pain in the lower extremities, which is rapidly relieved with rest. Patients with symptomatic PAD avoid exertion and tend to have muscle weakness, an altered gait and lower limb biomechanics. This results in impaired walking performance, accelerated functional decline, and reduced quality of life. Supervised exercise training (SET) is considered among first-line therapies for patients with symptomatic PAD, combined with general cardiovascular risk management, lifestyle adaptation and pharmacological treatment. The clinical benefits of SET for patients with PAD are well established, with improved walking capacity and an improved quality of life as the primary outcomes. Although without clear consistency, the guidelines give recommendations in terms of claudication pain severity, SET volume, duration, and frequency. However, no or little guidance is offered as far as training intensity is concerned. Most of the previous studies on SET, in the context of PAD, did not distinguish between symptom intensity and common training intensity measures such as % of maximal heart rate (%HRmax), % of HR reserve (%HRR), % of peak oxygen uptake (%VO2peak), % of VO2 reserve (%VO2R), or the rate of perceived exertion (RPE). A meta-analysis by Parmenter et al. showed that vigorous (%HRpeak: 77-96, %VO2peak: 64-90, RPE: 14-17) exercise training improved cardiorespiratory fitness (VO2peak) more than light- to-moderate exercise therapy intensity in patients with PAD, but the changes in walking performance in these patients remain to be determined. In a recent meta-analysis, we demonstrated that both training modality and exercise intensity (based on %peak heart rate, %peak oxygen uptake, or the rate of perceived exertion) should be considered when looking for the best results in patients with symptomatic PAD. More precisely, we showed that, when training modalities were considered, walking at vigorous intensity showed the greatest improvement in maximal walking distance (MWD), while walking at light-to-moderate intensity showed the greatest improvement in pain-free walking distance. We also showed that vigorous was superior to light-to-moderate exercise intensity in improving cardiorespiratory fitness; and that, when training modalities were considered, cycling and other non-walking forms of training performed at vigorous intensity elicited the greatest improvements in cardiorespiratory fitness. The results of our meta-analysis call for study of the individual roles of each exercise intensity and modality on walking performance and cardiorespiratory fitness in patients with symptomatic PAD. High-intensity interval training (HIIT) is composed of brief bursts of vigorous intensity interspersed with periods of rest or low-intensity exercise. HIIT may be better than moderate-intensity training (MIT) in improving cardiorespiratory fitness and functional capacity in patients with cardiovascular and metabolic diseases, but in patients with symptomatic PAD, the effects of such modalities on walking ability and cardiorespiratory fitness remain to be clearly determined. The primary objective of this study is to compare the effects of 12-week-long exercise training (short-duration high-intensity intervals vs. low-to-moderate intensity) on treadmill performance in patients with symptomatic PAD. It is hypothesized that treadmill performance would be improved to a greater extent after high-intensity exercise training

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Exercise, Rehabilitation, Physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Monocentric randomized controlled trial (2 groups): Group 1 (n=30): high-intensity interval training group (HIIT) Group 2 (n=30): low-to-moderate intensity training group (LowMod)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-intensity interval training group (HIIT)
Arm Type
Experimental
Arm Description
Exercise training sessions will consist in an alternation of brief periods (≤ 60 s) of work performed at high intensity and brief period of passive rest. Patient will be asked to complete 1 set of 10-15x60-s (or 2 sets of 5-7x60-s) walking intervals. This protocol will elicits moderate-to-severe claudication pain during exertion. The training intensity in the HIIT group will be set at ≥85% HRpeak recorded during the maximal cardiopulmonary exercise test.
Arm Title
Low-to-moderate intensity training group (LowMod group)
Arm Type
Experimental
Arm Description
Exercise training sessions will consist in an alternation of periods of work performed at moderate exercise intensity and period of passive rest. The training approach of the LowMod group will be similar to the training prescription usually adopted in patients with claudication. The exercise training intensity will be set at ≤76% HRpeak recorded during the maximal cardiopulmonary exercise test.
Intervention Type
Other
Intervention Name(s)
High-intensity interval training group (HIIT)
Intervention Description
Exercise training sessions will consist in an alternation of brief periods (≤ 60 s) of work performed at high intensity and brief period of passive rest. Patient will be asked to complete 1 set of 10-15x60-s (or 2 sets of 5-7x60-s) walking intervals. The training intensity in the HIIT group will be set at ≥85% HRpeak recorded during the maximal cardiopulmonary exercise test. The training intervention will consist of 36 walking sessions spread over 12 weeks. Each training session will lasted 30-60 min. The training intervention will be performed on a treadmill (Cosmed T150, Itlay), which is equipped with harness and chest belt to secure the patients and prevents falling. Each session started with a 5-min walking warm-up and ended with a 5min cool-down. During all the exercise training sessions, HR of the subjects will be continuously monitored (Polar M430, Finland).
Intervention Type
Other
Intervention Name(s)
Low-to-moderate intensity training group (LowMod group)
Intervention Description
Exercise training sessions will consist in an alternation of periods of work performed at moderate exercise intensity and period of passive rest. The training approach of the LowMod group will be similar to the training prescription usually adopted in patients with claudication. The exercise training intensity will be set at ≤76% HRpeak recorded during the maximal cardiopulmonary exercise test. The training intervention will consist of 36 walking sessions spread over 12 weeks. Each training session will lasted 30-60 min. The training intervention will be performed on a treadmill (Cosmed T150, Itlay), which is equipped with harness and chest belt to secure the patients and prevents falling. Each session started with a 5-min walking warm-up and ended with a 5min cool-down. During all the exercise training sessions, HR of the subjects will be continuously monitored (Polar M430, Finland).
Primary Outcome Measure Information:
Title
Walking performance
Description
Patients will perform an incremental treadmill test to determine the pain-free (PFWD) and maximal walking distance (MWD). Initial walking speed will be set at 3.2 km/h, and at 0% grade. The grade will be increased by 2% each 2 min.
Time Frame
This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 3 to 10 days following the last training session.
Secondary Outcome Measure Information:
Title
Functional walking performance
Description
Patients will perform a 6-minute walk test
Time Frame
This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 3 to 10 days following the last training session.
Title
Cardiorespiratory fitness (VO2peak)
Description
Patients will perform a maximal cardiopulmonary exercise test
Time Frame
This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 3 to 10 days following the last training session.
Title
Lower limb functional performance
Description
Patients will perform a stair climbing test, 30-s repeated sit-to-stand chair test, short physical performance battery test (SPPB), and 15 meters walking test
Time Frame
This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 3 to 10 days following the last training session.
Title
Spatiotemporal gait and foot kinematics parameters
Description
Spatiotemporal gait and foot kinematics parameters will be assessed during the 6-minute walking tests and during the 15 meters walking test
Time Frame
This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 3 to 10 days following the last training session.
Title
Muscle oxygenation during treadmill test
Description
Muscle oxygenation will be assessed during treadmill test by near-infrared spectroscopy (NIRS)
Time Frame
This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 3 to 10 days following the last training session.
Title
Vascular parameters
Description
Ankle - toe brachial index (ABI, TBI)
Time Frame
This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 3 to 10 days following the last training session.
Title
Self-perceived quality of life and walking (dis)abilities
Description
Self-perceived quality of life (Medical Outcomes Study Short-Form 36 (SF-36) and walking (dis)abilities (Walking Impairement Questionnaire, WIQ) will be assessed. Each questionnaire has scores on a 0-100 scale (0 (worse score) to 100 (best score)).
Time Frame
This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 3 to 10 days following the last training session.
Title
Total amount of physical activity
Description
The total amount of physical activity will be assessed by accelerometer
Time Frame
This will be assessed before and after the 3-month training program. The post-program assessment will be performed between 3 to 10 days following the last training session.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients with symptomatic PAD (Fontaine stage IIa/b); ABI ≤ 0.9 or drop by 20% following exercise treadmill test 1; TBI ≤ 0.6 if incompressible arteries (diabetes and renal insufficiency); Signed written informed consent form. Exclusion Criteria: Age < 18; Unable to walk at 3.2 km/h on a treadmill (slope 0%) at least 300 m; Previous participate in SET programs ≤ 1 year; Prior leg/foot amputation; Contraindication to exercise Neurological and neuromuscular disorders and other comorbidities (orthopedic, rheumatologic) leading to gait abnormalities. Known Pregnancy Incapacity of discernment
Facility Information:
Facility Name
CHUV
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucia Mazzolai, Prof
Phone
+41213144700
Email
lucia.mazzolai@chuv.ch
First Name & Middle Initial & Last Name & Degree
Stefano Lanzi, PhD
Phone
+41795564911
Email
stefano.lanzi@chuv.ch

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.

Learn more about this trial

High-intensity Intervals Versus Low-to-moderate-intensity Exercise Training in Patients With PAD

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