NCT02094144

Brief Summary

Community-dwelling women aged 55 or over are recruited at public meetings aimed at promoting physical activity in postmenopausal women. Women are eligible and enrolled in the study if they have no significant disease affecting lower limb function and if they have a sedentary lifestyle. All study participants provide written informed consent to participate to the study. Women are then randomized either to the control group (women have to maintain their lifestyle) or to the exercise group : 40 minutes of brisk walking 3d/wk for 6 months (two supervised sessions and one session performed one their own per week with a detailed program). The intensity of the program is adapted to the heart rate work and gradually increases over the 6-month program. The objective of the study is to determine the health benefits of brisk on walking ability, diet, muscle strength, balance, blood pressure, bone density, body weight, lean and fat mass, depression symptoms, behavioral, emotional responses, sleep quality, and biological indicators of health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 21, 2014

Completed
Last Updated

March 21, 2014

Status Verified

March 1, 2014

Enrollment Period

2.7 years

First QC Date

March 13, 2014

Last Update Submit

March 19, 2014

Conditions

Sedentary LifestylePostmenopausal Women

Keywords

SedentaryPhysical activityBrisk walkingPostmenopausal womenBody compositionBalanceMuscle strengthDepression, bone densityNutritionBiological effects

Outcome Measures

Primary Outcomes (1)

  • 6 minute-walking distance (6MDWS)

    6MWD was performed following ATS guidelines

    6 months

Secondary Outcomes (5)

  • Effect of the brisk walking program on body composition

    6 months

  • Effect of the brisk walking program on depression symptoms

    6 months

  • Effect of the brisk walking program on muscle strength

    6 months

  • Effect of the brisk walking program on biological parameters

    6 months

  • Effect of the brisk walking program on sleep quality

    6 months

Study Arms (2)

exercise group (brisk walking program)

OTHER

The intervention is named brisk walking program. It consists on achieve 40 minutes of brisk walking 3d/wk for 6 months (two supervised sessions and one session performed one their own per week with a detailed program). The intensity of the program is adapted to the heart rate work and gradually increases over the 6-month program

Other: Brisk walking program

control group (physical activity habits)

OTHER

The Intervention consists on maintain the lifestyle and especially their physical activity habits during 6 months

Other: physical activity habit

Interventions

Brisk walking programOTHER

The intervention consists on achieve 40 minutes of brisk walking 3d/wk for 6 months (two supervised sessions and one session performed one their own per week with a detailed program). The intensity of the program is adapted to the heart rate work and gradually increases over the 6-month program

exercise group (brisk walking program)
physical activity habitOTHER

The Intervention consists on maintain the lifestyle and especially their physical activity habits during 6 months

control group (physical activity habits)

Eligibility Criteria

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

You may qualify if:

  • postmenopausal women aged 55 or older
  • women were asked to provide a medical certificate of no contraindication to performing the 6MWD.

You may not qualify if:

  • rheumatoid arthritis, osteoarthritis, ischemic heart disease, previous joint replacement surgery or cerebrovascular disease affecting lower limb function, malignant tumors, any pain or medication known to alter physical performance (e.g., corticosteroids, estrogens, statins, or anti-estrogen drugs)
  • score value above 9.4 at the Physical Activity Questionnaire for the Elderly
  • a 6MWD greater than 105% of the predicted 6MWD based on Troosters' reference equation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Sedentary BehaviorMotor ActivityDepression

Condition Hierarchy (Ancestors)

BehaviorBehavioral Symptoms

Study Officials

  • Hubert Blain, MD, PhD

    Montpellier University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2014

First Posted

March 21, 2014

Study Start

January 1, 2008

Primary Completion

September 1, 2010

Study Completion

March 1, 2011

Last Updated

March 21, 2014

Record last verified: 2014-03

Locations

FR(1)