NCT03357016

Brief Summary

Postmenopausal women, as men, are more prone to central or android obesity than premenopausal women. Abdominal fat mass accumulation is associated with an increase of cardiovascular disease (CVD) risk. Most exercise programs designed for weight loss have focused on about 30 min several times per week of moderate intensity continuous training (MICT). Disappointingly, such exercise programs have led to either none or low fat loss. Accumulating evidence suggests that high intensity interval training (HIIT) should be an effective exercise protocol for reducing body fat of overweight individuals, especially at the abdominal level. Resistance Training (RT) is associated with increased muscle mass and strength gain in main muscles groups. Thus, RT seems to be an interesting strategy to fight against deconditioning and autonomy loss with age. Development of muscle mass enhances resting metabolism rate. Thus, RT could raise daily energy expenditure ie. substrates' oxidation including lipids. The aim of our study was to compare the effects of a 12-week moderate intensity continuous training (MICT) program with high intensity interval training (HIIT) program combined or not with a resistance training (RT) program on total abdominal and visceral fat mass and substrate utilization in postmenopausal women. It is hypothesized that HIIT compared to MICT program would result in significantly greater whole body and regional fat mass losses (abdominal and visceral) and would improve lipid oxidation at rest and during prolonged moderate exercise. It is also hypothesized that HIIT associated with RT could be the best strategy to reduce fat mass.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2018

Completed
Last Updated

August 10, 2018

Status Verified

December 1, 2017

Enrollment Period

1.3 years

First QC Date

November 13, 2017

Last Update Submit

August 9, 2018

Conditions

Keywords

interval trainingabdominal fat masspostmenopausal womenlipids oxidation

Outcome Measures

Primary Outcomes (1)

  • Change from baseline abdominal fat mass (g) after 3 months of training (T3-T0/T0 x 100)

    Total abdominal fat mass will be measured in all patients using DEXA based on the methodology of Martin and Jensen (1991; L1-L2 to pubic rami) before (baseline, T0) and after 3 months of training (T3).

    Baseline T0, 3 months after protocol starting

Secondary Outcomes (11)

  • Lipids oxidation evaluated by gas exchange measurements

    1 week, 3 months after protocol starting

  • Visceral fat mass

    Baseline T0, 3 months after protocol starting

  • Total fat mass

    Baseline T0, 3 months after protocol starting

  • Fat-free mass

    Baseline T0, 3 months after protocol starting

  • Plasma HbA1c

    Baseline T0, 3 months after protocol starting

  • +6 more secondary outcomes

Study Arms (3)

High Intensity Interval Training program (HIIT)

EXPERIMENTAL

Subjects perform three sessions of training during 12 weeks: 35 min at 50% maximal aerobic power on bicycle.

Other: Training programs

Moderate Intensity Continuous Training program (MICT)

EXPERIMENTAL

Subjects perform three sessions of training during 12 weeks: repeated cycles of sprinting for 8s and pedaling slowly for 12s (between 20 and 30 rpm) for a maximum of 60 repeats per session.

Other: Training programs

HIIT + Resistance Training program (RT)

EXPERIMENTAL

Subjects perform three sessions of training during 12 weeks: Each subject performed HIIT protocol and then a single set of 8 exercises with 1 ou 2min resting period between exercises. Each set consisted of 8-12 repetitions at about 80% maximum repetition.

Other: Training programs

Interventions

High Intensity Interval Training program (HIIT) vs. Moderate Intensity Continuous Training program (MICT) vs. High Intensity Interval Training program + Resistance Training program (HIIT+RT)

HIIT + Resistance Training program (RT)High Intensity Interval Training program (HIIT)Moderate Intensity Continuous Training program (MICT)

Eligibility Criteria

Age55 Years - 82 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women (55- 82 years)
  • BMI ≥ 25 and \< 40
  • Able to follow an exercise protocol
  • Eating behavior and physical activity stable since at least 3 month

You may not qualify if:

  • Subject not able to perform exercise after medical examination
  • Subject not able to perform bicycle exercise (pains)
  • Chronic infection
  • Use of β-blocker
  • Medical treatment that could interfere with the different outcome measures
  • Hormonal Replacement Therapy (HRT)
  • Regular consumption of alcohol
  • Refusal to sign the consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CREPS Vichy Auvergne

Bellerive-sur-Allier, 03321, France

Location

MeSH Terms

Conditions

Overweight

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Martine Duclos, Pr

    CHRU Gabriel Montpied Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Data collected on the volunteers will be made anonymous.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2017

First Posted

November 29, 2017

Study Start

February 1, 2017

Primary Completion

June 8, 2018

Study Completion

June 8, 2018

Last Updated

August 10, 2018

Record last verified: 2017-12

Locations