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Post Exercise Substrate Oxidation, Appetite and Energy Intakes in Overweight/Obese Postmenopausal Women (EScAPE) (EScAPE)

Primary Purpose

Overweight, Postmenopausal

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Moderate Intensity Continuous Exercise
High-Intensity Interval Exercise (1)
High-Intensity Interval Exercise (2)
Sponsored by
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Exercise Modalities, Postmenopausal women, High-intensity interval exercise, CHO and FAT oxidation, Appetite, Energy intakes, Enjoyment

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • CREPS Auvergne Rhône-Alpes / Vichy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Women with overweight or obesity

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Rate Perceive Exertion (RPE)
RPE evaluated with adapted Borg's Scale during exercise for each modalities
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.
Energy intakes
Estimated energy intakes using dietary questionnaires

Full Information

First Posted
April 21, 2020
Last Updated
April 26, 2020
Sponsor
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
Collaborators
CREPS Auvergne Rhône-Alpes / Vichy
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1. Study Identification

Unique Protocol Identification Number
NCT04364061
Brief Title
Post Exercise Substrate Oxidation, Appetite and Energy Intakes in Overweight/Obese Postmenopausal Women (EScAPE)
Acronym
EScAPE
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
Collaborators
CREPS Auvergne Rhône-Alpes / Vichy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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). 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Postmenopausal
Keywords
Exercise Modalities, Postmenopausal women, High-intensity interval exercise, CHO and FAT oxidation, Appetite, Energy intakes, Enjoyment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Masking Description
Data collected on the volunteers will be made anonymous
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Women with overweight or obesity
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Moderate Intensity Continuous Exercise
Intervention Description
Participant completed a moderate intensity continuous cycling exercise (MICE) during 35 min at 60-65% thPHRmax
Intervention Type
Other
Intervention Name(s)
High-Intensity Interval Exercise (1)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
High-Intensity Interval Exercise (2)
Intervention Description
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
Primary Outcome Measure Information:
Title
Post-exercise (2 hours) CHO and FAT oxidation
Description
CHO and FAT oxidation were measured after each modality with indirect calorimetry during 2 hours post-exercise
Time Frame
2 hours post-exercise
Secondary Outcome Measure Information:
Title
Enjoyment
Description
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.
Time Frame
Immediately post-exercise
Title
Rate Perceive Exertion (RPE)
Description
RPE evaluated with adapted Borg's Scale during exercise for each modalities
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.
Title
Appetite
Description
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.
Time Frame
Before, immediately post-exercise, 60 minutes and 120 minutes post-exercise
Title
Energy intakes
Description
Estimated energy intakes using dietary questionnaires
Time Frame
24 hours post-exercise

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire MOREL, Dr
Organizational Affiliation
CREPS Auvergne Rhône-Alpes / Vichy
Official's Role
Principal Investigator
Facility Information:
Facility Name
CREPS Auvergne Rhône-Alpes / Vichy
City
Bellerive-sur-Allier
State/Province
Allier
ZIP/Postal Code
03321
Country
France

12. IPD Sharing Statement

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Post Exercise Substrate Oxidation, Appetite and Energy Intakes in Overweight/Obese Postmenopausal Women (EScAPE)

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