Physical ActivityNCT03302923
Brisk Walking Study in Nursing Home Residents
A study testing Brisk walking in people with Physical Activity and Autonomic Nervous System Imbalance, run by Clinique Mutualiste Chirurgicale de la Loire at 1 site in France.
Trial summary
It is well established that physical activity reduces the physiological effects of ageing. Among them, the decrease of the autonomic nervous system activity (ANS) is associated with the increase of cardiovascular events and sleep disorders occurence. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Physical Activity, Autonomic Nervous System Imbalance
- What is being tested?
- Brisk walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2016to 30 Nov 2019
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being over 60 years old
- Living in a nursing home of Mutualité Française de la Loire, France
- Being able to walk without human aid
- Being able to speak and write French
- Being inactive (less than 1 hours of physical activity per week)
- Having a normal sinus rhythm
- Being affiliated to the social welfare system
- Signing the informed consent form
Who cannot join
- Having serious balance disorders
- Suffering from cardiac or respiratory pathologies that contraindicate physical activity
- Serious comorbidities contraindicating physical activity
- Diagnosed cardiac pathologies that prevent heart rate variability analysis: congestive heart failure, cardiac pacemaker, implantable cardioverter defibrillator, serious ventricular rhythm troubles, atrial fibrillation, atrial flutter.
- Persons under legal protection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
French Loire Mutuality
Saint-Etienne, 42100
Claude MONTUY-COQUARD, Me, 0477476309 ext. +33, CMontuyCoquard@mutualite-loire.com
Jean-Claude BARTHELEMY, MD, PhD
About this study
Official title: Effects of Brisk Walking on Autonomic Nervous System Reactivation in Nursing Home Residents.
It is well established that physical activity reduces the physiological effects of ageing. Among them, the decrease of the autonomic nervous system activity (ANS) is associated with the increase of cardiovascular events and sleep disorders occurence. It has been shown that high intensity cycle training can enhance the ANS activity by 30% in people aged of 70 years old. However, such trainings were done by old athletes used to train at intensities that could not be handled by nursing home elderly. Thus, an adapted activity such as brisk walking shall be defined to make it practicable for the many in convalescent homes. The investigators hypothesize that long term brisk walking training could lead to reactivate ANS in people living in convalescent homes.
Read the detailed description
The investigators aim to compare the effects of a 9 month brisk walking training (1 time a week or 3 times a week) on the ANS of nursing home residents.
- Being tested
- Brisk walking
- Keywords
- Nursing home residents, Brisk walking
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brisk walkingBehavioural
Prospective randomized clinical trial with 2 intervention groups and 1 control group.
| Study group | Role | What they receive |
|---|---|---|
| Brisk walking 1 | Experimental | 1 time a week of 9 months brisk walking Receives: Behavioral: Brisk walking |
| Brisk walking 3 | Experimental | 3 times a week of 9 months brisk walking Receives: Behavioral: Brisk walking |
| Control group | No intervention | No brisk walking session |
What is being measured
The primary outcome is the main question the study is designed to answer.
SDNN value
Standard deviation of all normal nocturnal RR intervals
Measured: 9 months
Secondary outcomes (17)
Heart rate variability parameters
Autonomic nervous system balance (RMSSD)
Measured: 9 months
Heart rate variability parameters
Autonomic nervous system balance (LF/HF)
Measured: 9 months
Heart rate variability parameters
Autonomic nervous system balance (Ptot)
Measured: 9 months
Baroreflex sensitivity (BRS)
BRS slope variation measured at rest
Measured: 9 months
Maximum oxygen uptake (VO2max)
Cardiopulmonary exercise testing
Measured: 9 months
Daily physical activity
Actimetry (Actigraph-GT3X)
Measured: 9 months
Daily physical activity
Adult physical activity questionnaire (APAQ)
Measured: 9 months
Sedentary periods
Actimetry (Actigraph GT3X)
Measured: 9 months
Sedentary periods
Adult physical activity questionnaire (APAQ)
Measured: 9 months
Muscular force
Lower limbs maximum voluntary force test measured on force chair
Measured: 9 months
Muscular endurance
Lower limbs endurance test measured on force chair
Measured: 9 months
Muscular volume gains
Lower limbs muscular magnetic resonance imaging (MRI)
Measured: 9 months
Plasmatic dosages of inflammatory molecules
CRP
Measured: 9 months
Plasmatic dosages of inflammatory molecules
TNF alpha
Measured: 9 months
Plasmatic dosages of inflammatory molecules
IL 17
Measured: 9 months
Cognitive improvements
Neuropsychological evaluation with a neuropsychologist.
Measured: 9 months
Quality of life
SF-36 questionnaire
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start1 Jun 2016
- Primary completion31 Aug 2018 (estimated)
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Mutualiste Chirurgicale de la Loire
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Saint-Etienne, University of Lyon
- Responsible party
- Sponsor
- Investigators
- David HUPIN, MD, PhD, Principal investigator, University Hospital of Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302923
- Sponsor's protocol ID
- 2016-08
- Other IDs
- 2016-A00068-43
- Status last verified
- May 2018
- First submitted
- 28 Sep 2017
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Brisk Walking on Autonomic Nervous System Reactivation in Nursing Home Residents.
- ClinicalTrials.gov ID
- NCT03302923
- Acronym / sponsor ID
- 2016-08
- Keywords
- Nursing home residents, Brisk walking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Clinique Mutualiste Chirurgicale de la LoireUniversity, hospital or other
- Collaborators
- University Hospital of Saint-Etienne, University of Lyon
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Aug 2018 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 5 Oct 2017 (actual)
- 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.
It is well established that physical activity reduces the physiological effects of ageing. Among them, the decrease of the autonomic nervous system activity (ANS) is associated with the increase of cardiovascular events and sleep disorders occurence. It has been shown that high intensity cycle training can enhance the ANS activity by 30% in people aged of 70 years old. However, such trainings were done by old athletes used to train at intensities that could not be handled by nursing home elderly. Thus, an adapted activity such as brisk walking shall be defined to make it practicable for the many in convalescent homes. The investigators hypothesize that long term brisk walking training could lead to reactivate ANS in people living in convalescent homes.
Detailed description
The investigators aim to compare the effects of a 9 month brisk walking training (1 time a week or 3 times a week) on the ANS of nursing home residents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brisk walking 1 | Experimental | Behavioral: Brisk walking1 time a week of 9 months brisk walking |
| Brisk walking 3 | Experimental | Behavioral: Brisk walking3 times a week of 9 months brisk walking |
| Control group | No intervention | –No brisk walking session |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Being over 60 years old
- Living in a nursing home of Mutualité Française de la Loire, France
- Being able to walk without human aid
- Being able to speak and write French
- Being inactive (less than 1 hours of physical activity per week)
Key exclusion criteria (5 listed)
- Having serious balance disorders
- Suffering from cardiac or respiratory pathologies that contraindicate physical activity
- Serious comorbidities contraindicating physical activity
- Diagnosed cardiac pathologies that prevent heart rate variability analysis: congestive heart failure, cardiac pacemaker, implantable cardioverter defibrillator, serious ventricular rhythm troubles, atrial fibrillation, atrial flutter.
- Persons under legal protection
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 walkingProspective randomized clinical trial with 2 intervention groups and 1 control group. | Behavioural | Brisk walking 1, Brisk walking 3 |
Primary outcome
SDNN value
Time frame: 9 months
Standard deviation of all normal nocturnal RR intervals
17 secondary outcomes
Heart rate variability parameters
Time frame: 9 months
Heart rate variability parameters
Time frame: 9 months
Heart rate variability parameters
Time frame: 9 months
Baroreflex sensitivity (BRS)
Time frame: 9 months
Maximum oxygen uptake (VO2max)
Time frame: 9 months
Daily physical activity
Time frame: 9 months
Daily physical activity
Time frame: 9 months
Sedentary periods
Time frame: 9 months
Sedentary periods
Time frame: 9 months
Muscular force
Time frame: 9 months
Muscular endurance
Time frame: 9 months
Muscular volume gains
Time frame: 9 months
Plasmatic dosages of inflammatory molecules
Time frame: 9 months
Plasmatic dosages of inflammatory molecules
Time frame: 9 months
Plasmatic dosages of inflammatory molecules
Time frame: 9 months
Cognitive improvements
Time frame: 9 months
Quality of life
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Individual participant dataSharing planned: No
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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.
David HUPIN, MD, PhD principal investigator
University Hospital of Saint-Etienne
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 in people with Physical Activity and Autonomic Nervous System Imbalance, run by Clinique Mutualiste Chirurgicale de la Loire 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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 May 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David HUPIN, MD, PhD (0477829109 ext. +33, david.hupin@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SDNN value (time frame: 9 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 9 May 2018.