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临床试验/NCT02094144
NCT02094144已完成不适用

Health Benefits of a 6-month Brisk Walking Program in Sedentary Postmenopausal Women : a Randomized Controlled Trial

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
126
试验地点
2
主要终点
6 minute-walking distance (6MDWS)

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

6 minute-walking distance (6MDWS)

时间窗: 6 months

6MWD was performed following ATS guidelines

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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