Brisk Walking Study in Nursing Home Residents

Not Applicable

• Conditions: Autonomic Nervous System Imbalance; Physical Activity

• Registration Number: NCT03302923
• Lead Sponsor: Clinique Mutualiste Chirurgicale de la Loire

Brief 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.

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 Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2017-09-28
• Study First Submitted QC: 2017-10-04
• Study First Posted: 2017-10-05
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-09
• Primary Completion: 2018-08-31
• Study Completion: 2019-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
SDNN value	9 months	Standard deviation of all normal nocturnal RR intervals

Secondary Outcome Measures

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

Trial Locations

Locations (1)

French Loire Mutuality; 🇫🇷 Saint-Étienne, France