OverweightEScAPENCT04364061
Post Exercise Substrate Oxidation, Appetite and Energy Intakes in Overweight/Obese Postmenopausal Women (EScAPE)
A study testing Moderate Intensity Continuous Exercise, High-Intensity Interval Exercise (1) and High-Intensity Interval Exercise (2) in people with Overweight and Postmenopausal, run by Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques at 1 site in France.
Trial summary
High-intensity interval exercise (HIIT), as compared to moderate intensity continuous training (MICT), is a time-efficient strategy to decrease total and abdominal fat mass (FM). Read more about this study
- Who is it for?
- Ages 50 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Postmenopausal
- What is being tested?
- Moderate Intensity Continuous Exercise, High-Intensity Interval Exercise (1) and High-Intensity Interval Exercise (2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2019to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- postmenopausal women (spontaneous amenorrhea for at least 12 months)
- with overweight or obesity (BMI > 25 kg/m2 and ≤ 40 kg/m2)
Who cannot join
- medical contraindications to intense physical activity,
- painful joints,
- taking hormone replacement therapy,
- taking B-blockers.
Trial locations and contacts
1 site in 1 country.
France1 site
CREPS Auvergne Rhône-Alpes / Vichy
Bellerive-sur-Allier, Allier, 03321
About this study
Official title: Comparison of Acute Cycling Modalities on Enjoyment, Post Exercise Substrate Oxidation, Appetite and Energy Intakes Over 24h in Postmenopausal Women With Overweight or Obesity
High-intensity interval exercise (HIIT), as compared to moderate intensity continuous training (MICT), is a time-efficient strategy to decrease total and abdominal fat mass (FM). However, the mechanisms underlying such adaptations are not yet elucidated and research are still needed to establish the optimal HIIT according to subject characteristics. The aim of this study was to compare acute HIIE and MICE cycling exercises on enjoyment, post-exercise substrate oxidation, appetite and energy intakes over 24h in postmenopausal women with overweight or obesity. It is hypothesized that compared with the traditional MICE, HIIE could favor greater enjoyment, higher 2h-post-exercise fat oxidation and a similar energy intakes over 24h despite different post-exercise appetite perceptions.
Read the 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:
- 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.
- Conditions
- Overweight, Postmenopausal
- Being tested
- Moderate Intensity Continuous Exercise, High-Intensity Interval Exercise (1), High-Intensity Interval Exercise (2)
- Keywords
- Exercise Modalities, Postmenopausal women, High-intensity interval exercise, CHO and FAT oxidation, Appetite, Energy intakes, Enjoyment
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Intensity Continuous ExerciseOther
Participant completed a moderate intensity continuous cycling exercise (MICE) during 35 min at 60-65% thPHRmax
High-Intensity Interval Exercise (1)Other
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
High-Intensity Interval Exercise (2)Other
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
| Study group | Role | What they receive |
|---|---|---|
| Women with overweight or obesity | Experimental | Not described Receives: Other: Moderate Intensity Continuous Exercise; Other: High-Intensity Interval Exercise (1); Other: High-Intensity Interval Exercise (2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-exercise (2 hours) CHO and FAT oxidation
CHO and FAT oxidation were measured after each modality with indirect calorimetry during 2 hours post-exercise
Measured: 2 hours post-exercise
Secondary outcomes (4)
Enjoyment
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.
Measured: Immediately post-exercise
Rate Perceive Exertion (RPE)
RPE evaluated with adapted Borg's Scale during exercise for each modalities
Measured: 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
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.
Measured: Before, immediately post-exercise, 60 minutes and 120 minutes post-exercise
Energy intakes
Estimated energy intakes using dietary questionnaires
Measured: 24 hours post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start1 Nov 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
- Sponsor type
- University, hospital or other
- Collaborators
- CREPS Auvergne Rhône-Alpes / Vichy
- Responsible party
- Sponsor
- Investigators
- Claire MOREL, Dr, Principal investigator, CREPS Auvergne Rhône-Alpes / Vichy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364061
- Sponsor's protocol ID
- IRB00012476-2020-24-03-50
- Acronym
- EScAPE
- Status last verified
- Apr 2020
- First submitted
- 21 Apr 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Acute Cycling Modalities on Enjoyment, Post Exercise Substrate Oxidation, Appetite and Energy Intakes Over 24h in Postmenopausal Women With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT04364061
- Acronym / sponsor ID
- EScAPE / IRB00012476-2020-24-03-50
- Conditions
- Overweight, Postmenopausal
- Keywords
- Exercise Modalities, Postmenopausal women, High-intensity interval exercise, CHO and FAT oxidation, Appetite, Energy intakes, Enjoyment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et PathologiquesUniversity, hospital or other
- Collaborators
- CREPS Auvergne Rhône-Alpes / Vichy
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High-intensity interval exercise (HIIT), as compared to moderate intensity continuous training (MICT), is a time-efficient strategy to decrease total and abdominal fat mass (FM). However, the mechanisms underlying such adaptations are not yet elucidated and research are still needed to establish the optimal HIIT according to subject characteristics. The aim of this study was to compare acute HIIE and MICE cycling exercises on enjoyment, post-exercise substrate oxidation, appetite and energy intakes over 24h in postmenopausal women with overweight or obesity. It is hypothesized that compared with the traditional MICE, HIIE could favor greater enjoyment, higher 2h-post-exercise fat oxidation and a similar energy intakes over 24h despite different post-exercise appetite perceptions.
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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with overweight or obesity | Experimental | Other: Moderate Intensity Continuous Exercise, Other: High-Intensity Interval Exercise (1), Other: High-Intensity Interval Exercise (2) |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- postmenopausal women (spontaneous amenorrhea for at least 12 months)
- with overweight or obesity (BMI > 25 kg/m2 and ≤ 40 kg/m2)
Key exclusion criteria (4 listed)
- medical contraindications to intense physical activity,
- painful joints,
- taking hormone replacement therapy,
- taking B-blockers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate Intensity Continuous ExerciseParticipant completed a moderate intensity continuous cycling exercise (MICE) during 35 min at 60-65% thPHRmax | Other | Women with overweight or obesity |
| High-Intensity Interval Exercise (1)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 | Other | Women with overweight or obesity |
| High-Intensity Interval Exercise (2)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 | Other | Women with overweight or obesity |
Primary outcome
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
4 secondary outcomes
Enjoyment
Time frame: 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.
Appetite
Time frame: Before, immediately post-exercise, 60 minutes and 120 minutes post-exercise
Energy intakes
Time frame: 24 hours post-exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire MOREL, Dr principal investigator
CREPS Auvergne Rhône-Alpes / Vichy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Intensity Continuous Exercise, High-Intensity Interval Exercise (1) and High-Intensity Interval Exercise (2) in people with Overweight and Postmenopausal, run by Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-exercise (2 hours) CHO and FAT oxidation (time frame: 2 hours post-exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.