Brisk Walking Study in Nursing Home Residents

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.

Study Overview

• Status: Unknown
• Conditions: Physical Activity; Autonomic Nervous System Imbalance
• Intervention / Treatment: Behavioral: Brisk walking

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France, 42100
    • Recruiting
    • French Loire Mutuality
    • Sub-Investigator: Paul CALMELS, MD
    • Contact: Claude MONTUY-COQUARD, Me; Phone Number: +33 0477476309; Email: CMontuyCoquard@mutualite-loire.com
    • Sub-Investigator: 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: Philippe TERRAT, MD
    • Sub-Investigator: Marie-Christine DIANA, MD
    • Sub-Investigator: Thierry BUSSO, PhD
    • Sub-Investigator: Diana RIMAUD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brisk walking 1; 1 time a week of 9 months brisk walking	Behavioral: Brisk walking; Prospective randomized clinical trial with 2 intervention groups and 1 control group.
Experimental: Brisk walking 3; 3 times a week of 9 months brisk walking	Behavioral: Brisk walking; Prospective randomized clinical trial with 2 intervention groups and 1 control group.
No Intervention: Control group; No brisk walking session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SDNN value	Standard deviation of all normal nocturnal RR intervals	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate variability parameters	Autonomic nervous system balance (RMSSD)	9 months
Heart rate variability parameters	Autonomic nervous system balance (LF/HF)	9 months
Heart rate variability parameters	Autonomic nervous system balance (Ptot)	9 months
Baroreflex sensitivity (BRS)	BRS slope variation measured at rest	9 months
Maximum oxygen uptake (VO2max)	Cardiopulmonary exercise testing	9 months
Daily physical activity	Actimetry (Actigraph-GT3X)	9 months
Daily physical activity	Adult physical activity questionnaire (APAQ)	9 months
Sedentary periods	Actimetry (Actigraph GT3X)	9 months
Sedentary periods	Adult physical activity questionnaire (APAQ)	9 months
Muscular force	Lower limbs maximum voluntary force test measured on force chair	9 months
Muscular endurance	Lower limbs endurance test measured on force chair	9 months
Muscular volume gains	Lower limbs muscular magnetic resonance imaging (MRI)	9 months
Plasmatic dosages of inflammatory molecules	CRP	9 months
Plasmatic dosages of inflammatory molecules	TNF alpha	9 months
Plasmatic dosages of inflammatory molecules	IL 17	9 months
Cognitive improvements	Neuropsychological evaluation with a neuropsychologist.	9 months
Quality of life	SF-36 questionnaire	9 months

Collaborators and Investigators

• Sponsor: Clinique Mutualiste Chirurgicale de la Loire
• Collaborators: University Hospital of Saint-Etienne; University of Lyon
• Investigators: Principal Investigator: David HUPIN, MD, PhD, University Hospital of Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Anticipated): August 31, 2018
• Study Completion (Anticipated): November 30, 2019

Study Registration Dates

• First Submitted: September 28, 2017
• First Submitted That Met QC Criteria: October 4, 2017
• First Posted (Actual): October 5, 2017

Study Record Updates

• Last Update Posted (Actual): May 9, 2018
• Last Update Submitted That Met QC Criteria: May 3, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Nursing home residents; Brisk walking
• Other Study ID Numbers: 2016-08; 2016-A00068-43 (Registry Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No