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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03357016
Other study ID # AU1303
Secondary ID 2016-A01742-49
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2017
Est. completion date June 8, 2018

Study information

Verified date December 2017
Source Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Overweight and obesity are dramatically spreading worldwide, and these trends are occurring in both developed and developing countries. Fat mass and more particularly abdominal fat mass is related to the development of cardio-vascular diseases (CVD). Postmenopausal women, as men, are more prone to central or android obesity.

Most exercise programs designed for weight loss have focused on about 30 min several times a week of moderate intensity continuous training (MICT). Disappointingly, such exercise programs have led to either none or low fat losses. Accumulating evidence suggests that high intensity interval training (HIIT) could be an effective exercise protocol for reducing adipose tissue of overweight individuals, especially at the abdominal level. HIIT involves brief high-intensity, anaerobic exercise followed by brief but slightly longer bouts of very low-intensity exercise.

Resistance training (RT) program are currently proposed in order to reduce fat mass / preserve fat-free mass. Their beneficial effects have been demonstrated, especially in the elderly. Through development (or maintenance) of muscle mass, RT increases resting metabolism rate, daily energy expenditure, and substrate (fatty acids) oxidation.

The aim of the study was to compare the effects of a 12-week moderate intensity continuous training (MICT) program with high intensity interval training (HIIT) combined or not with resistance training (RT) program on total, abdominal and visceral fat mass and substrate utilization at rest and during exercise in postmenopausal women.

36 postmenopausal women will be randomly assigned to MICT (n= 12) or HIIT (n= 12) or HIIT + RT (n= 12) group. Subjects performed three sessions per week during 12 weeks, on bicycle.

MICT: For the MICT protocol, each subject performed 35 min at 50% maximal aerobic power (MAP).

HIIT: For the HIIT protocol, each subject performed repeated cycles of sprinting for 8 s and pedaling slowly for 12 s (between 20 and 30 rpm) for a maximum of 60 repeats per session.

HIIT+RT: For the HIIT+RT protocol, each subject performed HIIT protocol. Then they performed a single set of 8 exercises with 1 or 2min resting period between exercises. Each set consisted of 8-12 repetitions at about 80% maximum repetition (MR).

Total body and regional fat content will be measured using dual-energy x-ray absorptiometry (DEXA) before and after the intervention (3 months).

The investigators will examine the effects of HIIT, MICT and HIIT + RT programs on:

- Total fat mass (and appendicular fat mass) (DEXA)

- Total fat free mass (and appendicular fat free mass) (DEXA)

- Glycemic profile (plasma HbA1c, plasma glucose)

- Lipid profile (TG, HDL, LDL, total cholesterol)

- Substrates oxidation at rest and during moderate exercise (40min, 50% of maximal oxygen consumption VO2 max)

Statistical analysis

Appropriate sample size has been calculated given previous results about fat mass loss during HIIT in women and considering the dropouts observed in this type of protocol.

Gaussian distribution of the data will be tested by the Kolmogorov-Smirnov test. Data will be presented as mean ± standard deviation (SD). Comparisons between groups will be made with Mann & Whitney U test or ANOVA when appropriate. Relationships between data will be assessed by Pearson correlation. Significance will be accepted at the p<0.05 level. Statistical procedures will be performed using Statistica software.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date June 8, 2018
Est. primary completion date June 8, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 55 Years to 82 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Subject not able to perform exercise after medical examination

- Subject not able to perform bicycle exercise (pains)

- Chronic infection

- Use of ß-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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France CREPS Vichy Auvergne Bellerive-sur-Allier

Sponsors (3)

Lead Sponsor Collaborator
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques CREPS Vichy Auvergne, University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Lipids oxidation evaluated by gas exchange measurements Evolution of lipids oxidation at rest and during prolonged moderate intensity (40min, 50% of VO2max) using an automated gas analysis system. Carbon dioxide (CO2) production and oxygen consumption (CO2) are expressed in L/min. Respiratory exchange ratio is the ratio between CO2 production and O2 consumption (RER = VCO2/VO2). 1 week, 3 months after protocol starting
Secondary Visceral fat mass Change from baseline in visceral fat mass (g) (estimated from DEXA) Baseline T0, 3 months after protocol starting
Secondary Total fat mass Change from baseline in total fat mass (g) (determined from DEXA) Baseline T0, 3 months after protocol starting
Secondary Fat-free mass Change from baseline in total fat-free mass (g) (determined from DEXA) Baseline T0, 3 months after protocol starting
Secondary Plasma HbA1c Change from baseline in plasma HbA1c Baseline T0, 3 months after protocol starting
Secondary Glucose level Change from baseline in plasma glucose measurement Baseline T0, 3 months after protocol starting
Secondary Plasma triglycerides Change from baseline in plasma triglycerides Baseline T0, 3 months after protocol starting
Secondary Plasma total cholesterol Change from baseline in total cholesterol Baseline T0, 3 months after protocol starting
Secondary Plasma HDL-cholesterol Change from baseline in HDL-cholesterol Baseline T0, 3 months after protocol starting
Secondary Plasma LDL-cholesterol Change from baseline in LDL-cholesterol Baseline T0, 3 months after protocol starting
Secondary Insulin level Change from baseline in plasma insulin measurement Baseline T0, 3 months after protocol starting
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