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.
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.
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.
- Conditions
- Sedentary Lifestyle, Postmenopausal Women
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: physical activity habit |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute-walking distance (6MDWS)
6MWD was performed following ATS guidelines
Measured: 6 months
Secondary outcomes (5)
Effect of the brisk walking program on body composition
Assesment of lean body mass and fat body mass
Measured: 6 months
Effect of the brisk walking program on depression symptoms
assessment with specific scale
Measured: 6 months
Effect of the brisk walking program on muscle strength
Measured: 6 months
Effect of the brisk walking program on biological parameters
measure of PTH, calcitriol (1,25 OHD)
Measured: 6 months
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.
- First posted21 Mar 2014 (estimated)
- Study startJan 2008
- Primary completionSep 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hubert Blain, MD, PhD, Principal investigator, University Hospital, Montpellier
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Benefits of a 6-month Brisk Walking Program in Sedentary Postmenopausal Women : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02094144
- Acronym / sponsor ID
- ACTIMARCH / 8189
- Conditions
- Sedentary Lifestyle, Postmenopausal Women
- Keywords
- Sedentary, Physical activity, Brisk walking, Postmenopausal women, Body composition, Balance, Muscle strength, Depression, bone density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 21 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise group (brisk walking program) | Other | Other: Brisk walking programThe 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 |
| control group (physical activity habits) | Other | Other: physical activity habitThe Intervention consists on maintain the lifestyle and especially their physical activity habits during 6 months |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- postmenopausal women aged 55 or older
- women were asked to provide a medical certificate of no contraindication to performing the 6MWD.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brisk walking programThe 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 | Other | exercise group (brisk walking program) |
| physical activity habitThe Intervention consists on maintain the lifestyle and especially their physical activity habits during 6 months | Other | control group (physical activity habits) |
Primary outcome
6 minute-walking distance (6MDWS)
Time frame: 6 months
6MWD was performed following ATS guidelines
5 secondary outcomes
Effect of the brisk walking program on body composition
Time frame: 6 months
Effect of the brisk walking program on depression symptoms
Time frame: 6 months
Effect of the brisk walking program on muscle strength
Time frame: 6 months
Effect of the brisk walking program on biological parameters
Time frame: 6 months
Effect of the brisk walking program on sleep quality
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hubert Blain, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
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.