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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has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

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.

02

Conditions studied

  • Physical Activity
  • Autonomic Nervous System Imbalance

Keywords

  • Nursing home residents
  • Brisk walking
03

Who can participate

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

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 informed consent 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
04

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.

05

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

06

Study locations

1 of 1 sites recruiting
  • French Loire Mutuality
    Saint-Étienne, 42100, France
    • Claude MONTUY-COQUARD, Me · Contact · CMontuyCoquard@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
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

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 ↗

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