ClinicalTrials.gg
Status unknownNCT03302923Updated May 9, 2018

Brisk Walking Study in Nursing Home Residents

An interventional study of Brisk walking in Physical Activity and Autonomic Nervous System Imbalance, sponsored by Clinique Mutualiste Chirurgicale de la Loire. Status unknown at 1 site in France. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2018-05-09.

Sponsored by Clinique Mutualiste Chirurgicale de la Loire · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Jun 2016, registered Sep 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 367 studies in Motor Activity with a site in France — 78 open to participants now, 90 under way, none of them phase 3. Motor Activity · France.

Planned enrollment
92nd of 269
100 · median 62
Started
2016
with 14 others
No phase
254 of 367
52 open now
Registered
119th of 367
by date

Among the 367 studies in Motor Activity with a site in France, this one is the 92nd largest by planned enrollment of the 269 interventional ones that give a count, is one of 15 that started in 2016, is one of 254 with no phase, and was the 119th registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

78 of the 367 studies in Motor Activity with a site in France are open now. Recruiting first, the newest first:

73 more — sign in →

All 78 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 60 Years and older · all sexes · no healthy volunteers.

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02

Study 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. 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.

03

Conditions studied

  • Physical Activity
  • Autonomic Nervous System Imbalance

Browse trials for

Keywords

  • Nursing home residents
  • Brisk walking
04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 form

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Brisk walking 1

    1 time a week of 9 months brisk walking

    Behavioral: Brisk walking

  • Experimental
    Brisk walking 3

    3 times a week of 9 months brisk walking

    Behavioral: Brisk walking

  • No intervention
    Control group

    No brisk walking session

Interventions

  • BehavioralBrisk walking

    Prospective randomized clinical trial with 2 intervention groups and 1 control group.

06

What researchers measure

Primary outcomes

  1. SDNN value

    Standard deviation of all normal nocturnal RR intervals

    Time frame: 9 months

Secondary outcomes

  1. Heart rate variability parameters

    Autonomic nervous system balance (RMSSD)

    Time frame: 9 months

  2. Heart rate variability parameters

    Autonomic nervous system balance (LF/HF)

    Time frame: 9 months

  3. Heart rate variability parameters

    Autonomic nervous system balance (Ptot)

    Time frame: 9 months

  4. Baroreflex sensitivity (BRS)

    BRS slope variation measured at rest

    Time frame: 9 months

  5. Maximum oxygen uptake (VO2max)

    Cardiopulmonary exercise testing

    Time frame: 9 months

  6. Daily physical activity

    Actimetry (Actigraph-GT3X)

    Time frame: 9 months

  7. Daily physical activity

    Adult physical activity questionnaire (APAQ)

    Time frame: 9 months

  8. Sedentary periods

    Actimetry (Actigraph GT3X)

    Time frame: 9 months

  9. Sedentary periods

    Adult physical activity questionnaire (APAQ)

    Time frame: 9 months

  10. Muscular force

    Lower limbs maximum voluntary force test measured on force chair

    Time frame: 9 months

  11. Muscular endurance

    Lower limbs endurance test measured on force chair

    Time frame: 9 months

  12. Muscular volume gains

    Lower limbs muscular magnetic resonance imaging (MRI)

    Time frame: 9 months

  13. Plasmatic dosages of inflammatory molecules

    CRP

    Time frame: 9 months

  14. Plasmatic dosages of inflammatory molecules

    TNF alpha

    Time frame: 9 months

  15. Plasmatic dosages of inflammatory molecules

    IL 17

    Time frame: 9 months

  16. Cognitive improvements

    Neuropsychological evaluation with a neuropsychologist.

    Time frame: 9 months

  17. Quality of life

    SF-36 questionnaire

    Time frame: 9 months

07

Study locations

1 of 1 sites recruiting
  • French Loire Mutuality
    Saint-Étienne, 42100, France
    Recruiting
    • Claude MONTUY-COQUARD, Me · ContactCMontuyCoquard@mutualite-loire.com · 0477476309
    • Jean-Claude BARTHELEMY, MD, PhD · Sub investigator
    • Frédéric ROCHE, MD, PhD · Sub investigator
    • Léonard FEASSON, MD, PhD · Sub investigator
    • Pascal EDOUARD, MD, PhD · Sub investigator
    • Paul CALMELS, MD · Sub investigator
    • Philippe TERRAT, MD · Sub investigator
    • Marie-Christine DIANA, MD · Sub investigator
    • Thierry BUSSO, PhD · Sub investigator
    • Diana RIMAUD, PhD · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2016 (actual). Primary completion is estimated for Aug 2018, 26 months after the start.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 26 months is above that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 28, 2017
First posted
Oct 5, 2017
StartActual
Jun 1, 2016
Primary completionEst.
Aug 31, 2018
CompletionEst.
Nov 30, 2019
Last update
May 9, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03302923
Lead sponsor
Clinique Mutualiste Chirurgicale de la Loire
Collaborators
University Hospital of Saint-Etienne, University of Lyon
Responsible party
Sponsor
First posted
Oct 5, 2017
Start date
Jun 1, 2016
Primary completion
Aug 31, 2018 (estimated)
Completion
Nov 30, 2019 (estimated)
Last update
May 9, 2018

Study contacts

David HUPIN, MD, PhD
Contact
david.hupin@chu-st-etienne.fr
0477829109 ext. +33
David HUPIN, MD, PhD
principal investigator · University Hospital of Saint-Etienne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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