- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05249205
The Effect of Training Frequency on Improvements in VO2max With REHIT
The Effect of Training Frequency on Improvements in Maximal Aerobic Capacity With Reduced-exertion High-intensity Interval Training (REHIT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Up to 45 apparently healthy participants will be recruited at multiple sites. Eligible participants will complete a fitness test to measure pre-training maximal aerobic capacity (V̇O2max). Participants will start cycling on a stationary bike at a low intensity (30 W). The intensity will increase by 1 W every 3 seconds until volitional exhaustion or an inability to maintain a pedalling frequency of >60 rpm. Expired O2 and CO2 will be continuously measured breath-by-breath using an online gas analyser. V̇O2max will be determined as the highest value for a 15-breath rolling average of V̇O2. V̇O2max will be accepted if at least 2 of the following criteria are met: volitional exhaustion / inability to maintain a pedal frequency of 60 rpm, RER>1.10, a plateau in V̇O2, and/or heart rate within 10 bpm of the age predicted maximum (220-age).
Participants will then be randomised into one of 3 groups, performing either 1 or 2 REHIT training sessions per week, or no training intervention (control group). Randomisation will be performed using the sealed envelope method. Participants in the control group will be asked to maintain their regular lifestyle for 6 weeks. Participants in the training groups will perform 6 weeks of REHIT. Each REHIT session involves 10 min of unloaded pedalling interspersed with 2 all-out cycle sprints against a resistance equivalent to 7.5% of the participant's body weight. Sprint duration will be 10 s in week 1, 15 s in week 2, and 20 s in the remaining 4 weeks. The first sprint will finish at 2 min and the second sprint will finish at 6 min. Participants will be instructed to start pedalling as fast as they can ~2-3 s before applying the sprint resistance, and to keep pedalling as fast as they can during the sprint. Verbal encouragement will be provided. Heart rate and power output will be measured throughout each 10-minute exercise session. The post-training V̇O2max test will be scheduled 3 days following the last training session.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Swansea, United Kingdom, SA1 8EN
- Swansea University
-
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Stirlingshire
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Stirling, Stirlingshire, United Kingdom, FK9 4LA
- University of Stirling
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Worcestershire
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Worcester, Worcestershire, United Kingdom
- University of Worcester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Apparently healthy
- Sedentary or recreationally active
Exclusion Criteria:
- Classified as highly physically active on the International Physical Activity Questionnaire (IPAQ)
- Answering 'Yes' to any of the questions of a standard Physical Activity Readiness Questionnaire (PAR-Q)
- Resting heart rate >100 bpm
- Resting blood pressure > 140/90 mm Hg
- BMI > 35 kg/m2
- Testing positive for Covid-19
- Pregnant women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Participants in the control group will be asked to maintain their regular lifestyle for the duration of the study.
They will not receive an intervention.
|
|
Experimental: REHIT1
Participants in the REHIT1 group will perform a single REHIT session per week for 6 weeks.
|
This intervention involves a single REHIT exercise session per week.
REHIT involves 10 minutes of unloaded cycling on a stationary bike interspersed with two 20-second 'all-out' cycle sprints against a resistance equivalent to 7.5% of body mass.
Other Names:
|
Experimental: REHIT2
Participants in the REHIT2 group will perform 2 REHIT sessions per week for 6 weeks.
|
This intervention is the same as that for the REHIT1 intervention, but with 2 sessions per week instead of 1.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in maximal aerobic capacity (VO2max)
Time Frame: Pre-intervention and 3 days following completion of the intervention.
|
VO2max is the greatest volume of oxygen an individual can consume per minute.
It is a key health marker.
|
Pre-intervention and 3 days following completion of the intervention.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NICR4056
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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