Brisk Walking Study in Nursing Home Residents

Physical Activity Clinical Trial

Official title:

Effects of Brisk Walking on Autonomic Nervous System Reactivation in Nursing Home Residents.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03302923
• Other study ID #: 2016-08
• Secondary ID: 2016-A00068-43
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: November 30, 2019

Study information

• Verified date: May 2018
• Source: Clinique Mutualiste Chirurgicale de la Loire
• Contact: David HUPIN, MD, PhD
• Phone: 0477829109
• Email: david.hupin[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 30, 2019
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autonomic Nervous System Imbalance
• Physical Activity

Intervention

Behavioral:
• Brisk walking
Prospective randomized clinical trial with 2 intervention groups and 1 control group.

Locations

Country	Name	City	State
France	French Loire Mutuality	Saint-Étienne

Sponsors (3)

Lead Sponsor	Collaborator
Clinique Mutualiste Chirurgicale de la Loire	University Hospital of Saint-Etienne, University of Lyon

Country where clinical trial is conducted

France, 

Outcome

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