- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04364061
Post Exercise Substrate Oxidation, Appetite and Energy Intakes in Overweight/Obese Postmenopausal Women (EScAPE) (EScAPE)
Comparison of Acute Cycling Modalities on Enjoyment, Post Exercise Substrate Oxidation, Appetite and Energy Intakes Over 24h in Postmenopausal Women With Overweight or Obesity
Study Overview
Status
Conditions
Detailed Description
The aim of this study was to compare acute HIIE and MICE cycling exercises on enjoyment, post-exercise substrate oxidation, and appetite and energy intakes over 24h in postmenopausal women with overweight or obesity.
Using a randomized crossover design, 12 postmenopausal women completed 3 cycling exercises at 6-days intervals:
i) Moderate Intensity Continuous Exercise (MICE) which consisted of 35 min cycling at 60-65% theorical Peak Heart Rate (thPHR) ii) High Intensity Interval Exercise 1 (HIIE 1) 60 cycles of speeding up for 8 s at 80-90%thPHR followed by pedaling slowly for 12 s (20min) iii) High Intensity Interval Exercise 2 (HIIE 2) which consisted of repeated 10 x 1min at 80-90% thPHR followed by pedaling slowly for 1min.
Substrate oxidation (CHO and FAT) were measured at rest and 2h- post exercise. Enjoyment, perceived exertion and appetite were recorded and post-exercise energy intakes were assessed over 24h.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Allier
-
Bellerive-sur-Allier, Allier, France, 03321
- CREPS Auvergne Rhône-Alpes / Vichy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- postmenopausal women (spontaneous amenorrhea for at least 12 months)
- with overweight or obesity (BMI > 25 kg/m2 and ≤ 40 kg/m2)
Exclusion Criteria:
- medical contraindications to intense physical activity,
- painful joints,
- taking hormone replacement therapy,
- taking B-blockers.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Women with overweight or obesity
|
Participant completed a moderate intensity continuous cycling exercise (MICE) during 35 min at 60-65% thPHRmax
Participant completed a high-intensity interval cycling exercise (HIIE 1) during 20min with 60 cycles of speeding up for 8s and pedaling slowly for 12s at 80-90% thPHRmax
Participant completed a high-intensity interval cycling exercise (HIIE 2) during 20min with 10 x 1-min bouts at 80-90% thPHRmax, separated by 1-min recovery bouts
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-exercise (2 hours) CHO and FAT oxidation
Time Frame: 2 hours post-exercise
|
CHO and FAT oxidation were measured after each modality with indirect calorimetry during 2 hours post-exercise
|
2 hours post-exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Enjoyment
Time Frame: Immediately post-exercise
|
Perceive enjoyment evaluated with Physical Activity Enjoyment Scale (PAES) for each modalities.
The total scores of PAES are between 18 and 126 with the higher scores indicating greater enjoyment.
|
Immediately post-exercise
|
|
Rate Perceive Exertion (RPE)
Time Frame: During exercise (5-10-15 and 20 minutes for HIIE1 and 2 ; 9-18-27 and 35 minutes for MICE) which corresponds at 25-50-75 and 100% of bout completion.
|
RPE evaluated with adapted Borg's Scale during exercise for each modalities
|
During exercise (5-10-15 and 20 minutes for HIIE1 and 2 ; 9-18-27 and 35 minutes for MICE) which corresponds at 25-50-75 and 100% of bout completion.
|
|
Appetite
Time Frame: Before, immediately post-exercise, 60 minutes and 120 minutes post-exercise
|
The validated 100 millimeters Visual Analogue Scale (VAS) was used to assess the subjective appetite at 4 time points: before, immediately post-exercise, 60 minutes and 120 minutes post-exercise.
This scale comprised four questions anchored with words representing the opposing extreme states of desire to eat, hunger, fullness and prospective food consumption.
The score of each question are between 0 and 100.
|
Before, immediately post-exercise, 60 minutes and 120 minutes post-exercise
|
|
Energy intakes
Time Frame: 24 hours post-exercise
|
Estimated energy intakes using dietary questionnaires
|
24 hours post-exercise
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Claire Morel, Dr, CREPS Auvergne Rhône-Alpes / Vichy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00012476-2020-24-03-50
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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