- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05875051
REHIT Versus SMIT in Sedentary Young Women (REHIT)
May 24, 2023 updated by: Elena Marques-Sule, University of Valencia
Effects of Reduced-exertion High-intensity Training Versus Short Moderate Intensity Training on Functional Capacity and Physical Activity Enjoyment in Sedentary Young Women A Randomized Trial
Reduced-exertion high-intensity training (REHIT) is a novel form of exercise known for being non-classical, time-efficient, and effective on different populations.
However, REHIT was scarcely tested on sedentary women with mortality risks.
The aim of the study is to compare the effects of REHIT versus short moderate-intensity training (SMIT) on functional capacity, resting heart rate (RHR), and activity enjoyment in sedentary young women.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The aim of the study is to compare the effects of reduced-exertion high-intensity training (REHIT) versus short moderate-intensity training (SMIT) on functional capacity, resting heart rate (RHR), and activity enjoyment in sedentary young women.
Therefore, sedentary young women will be randomly allocated to either a: i) REHIT group or ii) SMIT group.
Both groups will perform an intervention over 6 weeks duration for 10 minutes each session for 2 sessions/week, but with different intensities (REHIT or SMIT).
Both forms of exercise will be conducted on a cycle ergometer with the subjects monitored throughout the intervention.
Before and after the 3-week intervention, functional capacity (6-minute walking test) and RHR will be measured.
Additionally, physical activity enjoyment (Physical Activity Enjoyment Scale) will be assessed after the intervention.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Valencia, Spain, 46010
- University of Valencia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Women.
- Age between 18 and 25 years old.
- Those who score a low physical activity level (< 600 METS min/week) in the International Physical Activity Questionnaire-short form.
Exclusion Criteria:
- Women who suffer from musculoskeletal.
- Women who suffer from neurological diseases.
- Those who are taking medications.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Reduced-exertion high intensity training group
The REHIT part will consist of maximum cycling sprints of all-out exercise at 100% of the HRmax, increasing for up to 10 seconds, 15 seconds on week two and 20 seconds on week three.
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The intervention of the REHIT group will consist of three parts: i) 3 minutes of warm-up part at 50% of HRmax obtained in the effort test; ii) 3 min 20 sec to 3 min 40 sec of REHIT; and iii) 3 minutes of cool-down at 50% of HRmax obtained in the effort test.
The REHIT part will consist of maximum cycling sprints of all-out exercise at 100% of the HRmax, increasing for up to 10 seconds, 15 seconds on week two and 20 seconds on week three.
Then, 3 minutes of active rest at 50% of HRmax.
Finally, 10 seconds of all-out exercise at 100% of the HRmax, rising to 15 seconds on week two and 20 seconds on week three.
|
|
Active Comparator: Short moderate intensity training group
The SMIT part of the session will consist of 6 minutes of moderate intensity exercise at 60-70% HRmax.
|
The SMIT group will receive a short moderate-intensity training with the same warm-up and cool-down exercises as the REHIT group.
In addition, the main part of the session consisted of 6 minutes of moderate intensity exercise at 60-70% HRmax obtained in the effort test.
In addition, the main part of the session increases 3 min every week as 6 min for the first 2 weeks, 9 min for the 3rd and 4th weeks, and 12 min for the last two weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional capacity
Time Frame: Baseline
|
It will be measured using the 6-minutes walking test (6MWT).
Participants will be instructed to walk as quickly as possible along a 30-meter hallway for a duration of six minutes without running.
Then, the distance in meters they cover will be registered.
The greater the number of meters run, the better the functional capacity.
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Baseline
|
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Functional capacity
Time Frame: After the intervention (3 weeks)
|
It will be measured using the 6-minutes walking test (6MWT).
Participants will be instructed to walk as quickly as possible along a 30-meter hallway for a duration of six minutes without running.
Then, the distance in meters they cover will be registered.
The greater the number of meters run, the better the functional capacity.
|
After the intervention (3 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resting heart rate
Time Frame: Baseline
|
It will be measured with a patient monitor (ProAct PC-3000 Patient Monitor, Medisave, UK).
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Baseline
|
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Resting heart rate
Time Frame: After the intervention (3 weeks)
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It will be measured with a patient monitor (ProAct PC-3000 Patient Monitor, Medisave, UK).
|
After the intervention (3 weeks)
|
|
Physical activity enjoyment
Time Frame: Baseline
|
To assess enjoyment, a modified version of the Physical Activity Enjoyment Scale (PACES) will be used.
In this questionnaire, 17 items are scored on a 7-point bipolar scale, with an overall enjoyment score ranging from 17 (not enjoyable) to 68 (neutral) and 119 (enjoyable).
|
Baseline
|
|
Physical activity enjoyment
Time Frame: After the intervention (3 weeks)
|
To assess enjoyment, a modified version of the Physical Activity Enjoyment Scale (PACES) will be used.
In this questionnaire, 17 items are scored on a 7-point bipolar scale, with an overall enjoyment score ranging from 17 (not enjoyable) to 68 (neutral) and 119 (enjoyable).
|
After the intervention (3 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elena Marqués Sulé, PhD, Univeristy of Valencia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Metcalfe RS, Atef H, Mackintosh K, McNarry M, Ryde G, Hill DM, Vollaard NBJ. Time-efficient and computer-guided sprint interval exercise training for improving health in the workplace: a randomised mixed-methods feasibility study in office-based employees. BMC Public Health. 2020 Mar 12;20(1):313. doi: 10.1186/s12889-020-8444-z.
- Ramirez-Velez R, Hernandez-Quinones PA, Tordecilla-Sanders A, Alvarez C, Ramirez-Campillo R, Izquierdo M, Correa-Bautista JE, Garcia-Hermoso A, Garcia RG. Effectiveness of HIIT compared to moderate continuous training in improving vascular parameters in inactive adults. Lipids Health Dis. 2019 Feb 4;18(1):42. doi: 10.1186/s12944-019-0981-z.
- Metcalfe RS, Tardif N, Thompson D, Vollaard NB. Changes in aerobic capacity and glycaemic control in response to reduced-exertion high-intensity interval training (REHIT) are not different between sedentary men and women. Appl Physiol Nutr Metab. 2016 Nov;41(11):1117-1123. doi: 10.1139/apnm-2016-0253. Epub 2016 Jul 7.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2021
Primary Completion (Actual)
April 30, 2022
Study Completion (Actual)
April 30, 2022
Study Registration Dates
First Submitted
May 16, 2023
First Submitted That Met QC Criteria
May 24, 2023
First Posted (Actual)
May 25, 2023
Study Record Updates
Last Update Posted (Actual)
May 25, 2023
Last Update Submitted That Met QC Criteria
May 24, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 035/3/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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