AzTrials
AzTrials

Sedentary LifestyleACTIMARCHNCT02094144

Health Benefits of a 6-month Brisk Walking Program in Sedentary Postmenopausal Women

A study testing Brisk walking program and physical activity habit in people with Sedentary Lifestyle and Postmenopausal Women, run by University Hospital, Montpellier at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 55 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Sedentary Lifestyle, Postmenopausal Women
What is being tested?
Brisk walking program and physical activity habit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteFrance
Study dates
Jan 2008to Mar 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Montpellier University Hospital

    Montpellier, 34295

Other trials in France

About this study

Official 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.

Read the detailed description

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:

  • Body composition (bone density, body lean and fat mass by dual-energy X-ray absorptiometry (DXA) (Hologic QDR-1500 device, Hologic, Waltham, MA, USA);
  • The subjects are weighed on an electronic scale to the nearest 0.1 kg, and their height is measured to the nearest 0.1 cm to calculate the body mass index (BMI)(kg/m²).
  • Endurance training performance is estimated by the distance walked during the 6-minute walk test (6MWT). The 6MWT is performed according to the American Thoracic Society (2002) guidelines in an indoor corridor (ATS, 2002).
  • Maximum grip strength and isometric maximum knee extension strength are measured after a warm-up session, as previously described (Blain et al., 2010).
  • The Diet over the previous 7 days using the questionnaire used in the SUVIMAX study
  • Sleep quality
  • Depression score : French version of the Beck Depression Inventory (BDI) (Beck, Steer, \& Carbin, 1988; Cathébras, Mosnier, Lévy, Bouchou, \& Rousset, 1994). The BDI contains cognitive (e.g., pessimism, worthlessness) and physical (e.g., fatigue and loss of energy) subscales. The BDI has been shown to be sensitive to exercise-induced changes in healthy adults (Stein \& Motta, 1992).
  • Baseline physical activity, covering household activities, sports, and leisure activities is assessed using PAQE (Voorrips, Ravelli, Dongelmans, Deurenberg, \& Van Staveren, 1991). The activities of walking outside, bicycling, and doing heavy housework are summed to a physical activity score (range, 0-3). Respondents not participating in any activity are given zero points, whereas three points corresponds to participation in all three activities.
  • Subjective health status is assessed with the following item: In comparison to people with the same age, you consider your health as better (1), equal (2), worst (3) ?.
  • The Tampa Scale for Kinesiophobia (TSK) is a 17-item questionnaire that assesses the fear of (re)injury due to movement (Swinkels-Meewisse, Swinkels, Verbeek, Vlaeyen, \& Oostendorp, 2003). Women are asked to make ratings of their degree of agreement with each of the 17 statements. Ratings are summed to yield a total score where higher values reflect greater fear of (re)injury (French, France, Vigneau, French, \& Evans, 2007).
  • Balance is assessed using a force platform (Medicapteurs France SAS) with two conditions tested, eyes open (EO) and eyes closed (EC), lasting 51.2 seconds each and separated by a 30-second rest period. The COP trajectories in antero-posterior (AP) and medio-lateral (ML) directions are sampled at 40 Hz, leading time series with length of 2048.

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)

  • The adherence rate to the brisk walking program is calculated based on the data recorded in the notebooks (number of supervised and self-reported home based walking sessions performed/72 sessions of the program).
  • Individual content of the training (meters walked measured with a podometer; total duration of the walking exercises, mean HR, etc…).
  • Fasted morning blood samples are collected at baseline and at the end of the study and aliquots are frozen at -80 °C until analysis.
Being tested
Brisk walking program, physical activity habit
Keywords
Sedentary, Physical activity, Brisk walking, Postmenopausal women, Body composition, Balance, Muscle strength, Depression, bone density, Nutrition, Biological effects
Medical subject headings
Sedentary Behavior, Motor Activity, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • physical activity habitOther

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

Study groups in NCT02094144
Study groupRoleWhat they receive
exercise group (brisk walking program)OtherThe 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
Receives: Other: Brisk walking program
control group (physical activity habits)OtherThe Intervention consists on maintain the lifestyle and especially their physical activity habits during 6 months
Receives: Other: physical activity habit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6 minute-walking distance (6MDWS)

    6MWD was performed following ATS guidelines

    Measured: 6 months

Secondary outcomes (5)
  1. Effect of the brisk walking program on body composition

    Assesment of lean body mass and fat body mass

    Measured: 6 months

  2. Effect of the brisk walking program on depression symptoms

    assessment with specific scale

    Measured: 6 months

  3. Effect of the brisk walking program on muscle strength

    Measured: 6 months

  4. Effect of the brisk walking program on biological parameters

    measure of PTH, calcitriol (1,25 OHD)

    Measured: 6 months

  5. Effect of the brisk walking program on sleep quality

    Assessment with specific scale

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2014 (estimated)
  2. Study startJan 2008
  3. Primary completionSep 2010
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02094144
Sponsor's protocol ID
8189
Acronym
ACTIMARCH
Status last verified
Mar 2014
First submitted
13 Mar 2014
Last updated
21 Mar 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Brisk walking program and physical activity habit in people with Sedentary Lifestyle and Postmenopausal Women, run by University Hospital, Montpellier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6 minute-walking distance (6MDWS) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2014.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in