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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Spain
      • Valencia, Spain, 46010
        • University of Valencia

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Reduced-exertion high intensity training
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.
Other: Short moderate intensity training
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Baseline
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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).
Baseline
Resting heart rate
Time Frame: After the intervention (3 weeks)
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Valencia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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