Montpellier University Hospital
Montpellier, 34295, France
NCT Number: NCT02094144
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.
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Notify Me55 year and older
Female
Interventional
Not applicable
Montpellier, 34295, France
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 meet the following criteria : (i) not diagnosed with any of the following conditions: rheumatoid arthritis, osteoarthritis, ischemic heart disease, previous joint replacement surgery or cerebrovascular disease affecting lower limb function, malignant tumors, (ii) without pain and medication known to alter physical performance (e.g., corticosteroids, estrogens, statins, or anti-estrogen drugs). To recruit a sample of asymptomatic sedentary postmenopausal women, women with a score value above 9.4 at the Physical Activity Questionnaire for the Elderly (PAQE) (Serres, Gautier, Varray, & Préfaut, 1998) and a 5-minute walking distance (6MWD) greater than105% of the predicted 6MWD based on Troosters' reference equation are excluded. The Troosters' reference equation is:
Before entering the study, women are asked to provide a medical certificate of no contraindication to performing the 6MWD.
Women are then randomized either to the control group (women are asked to maintain their lifestyle, and especially their physical activity habits) or to the exercise group.
The exercise intervention consists in 40 minutes of brisk walking 3d/wk for 6 months. During the 6-month program, subjects are required to attend 2 outdoor supervised sessions per week, and to exercise 1d/wk on their own, with a detailed and tailored program. The intensity of walking is adapted by skilled exercise trainers to individual physical capability of each subject. Considering that the theoretical maximum heart rate (HR) of the subject is 208-0.7 * age (Tanaka, Monahan, & Seals, 2001), the training starts at 40% of HR work (difference between maximum HR and HR at rest). Training intensity is gradually increased to finally reaching 75% of the HR work. Participants wear a heart rate monitor (Polar Elctro Inc, Woodbury, NY) during each of the 3 weekly sessions and the content of each session is collected in a notebook (meters walked, duration of the brisk walking exercise, HR, adherence to the program).
This study is approved by the Committee for Protection of Human Subjects (CPP Sud-Méditerranée III, Number: 2008.07.04). All study participants provide a written informed consent to participating to the study.
The objectives of the study are to determine the health benefits of the intervention program in comparison to the control group in several domains.
Mesurements at baseline and at the end of the study comprise:
Traditional stabilometric measures : the AP and ML standard deviations (SDx and SDy, mm), the effective COP path length (mm), and the area of the 90% confidence ellipse enclosing the COP (mm²).
Complexity measures of postural sway : The complexity of postural sway is quantified by means of three measures : Percentage of determinism of recurrence quantification analysis (DETRQA) , Sample entropy (SampEn), Complexity index of multiscale entropy (CIMSE)
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
The Intervention consists on maintain the lifestyle and especially their physical activity habits during 6 months
Time frame: 6 months
6MWD was performed following ATS guidelines
Time frame: 6 months
Assesment of lean body mass and fat body mass
Time frame: 6 months
assessment with specific scale
Time frame: 6 months
Time frame: 6 months
measure of PTH, calcitriol (1,25 OHD)
Time frame: 6 months
Assessment with specific scale
University Hospital, Montpellier
Other
Health Benefits of a 6-month Brisk Walking Program in Sedentary Postmenopausal Women : a Randomized Controlled Trial
Acronym: ACTIMARCH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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