Sedentary Lifestyle Clinical Trial
— ACTIMARCHOfficial title:
Health Benefits of a 6-month Brisk Walking Program in Sedentary Postmenopausal Women : a Randomized Controlled Trial
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.
Status | Completed |
Enrollment | 126 |
Est. completion date | March 2011 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 55 Years and older |
Eligibility |
Inclusion Criteria: - postmenopausal women aged 55 or older - women were asked to provide a medical certificate of no contraindication to performing the 6MWD. Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
France | Montpellier University Hospital | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 6 minute-walking distance (6MDWS) | 6MWD was performed following ATS guidelines | 6 months | No |
Secondary | Effect of the brisk walking program on body composition | Assesment of lean body mass and fat body mass | 6 months | No |
Secondary | Effect of the brisk walking program on depression symptoms | assessment with specific scale | 6 months | No |
Secondary | Effect of the brisk walking program on muscle strength | 6 months | No | |
Secondary | Effect of the brisk walking program on biological parameters | measure of PTH, calcitriol (1,25 OHD) | 6 months | Yes |
Secondary | Effect of the brisk walking program on sleep quality | Assessment with specific scale | 6 months | No |
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