NCT03302923

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

2.2 years

First QC Date

September 28, 2017

Last Update Submit

May 3, 2018

Conditions

Physical ActivityAutonomic Nervous System Imbalance

Keywords

Nursing home residentsBrisk walking

Outcome Measures

Primary Outcomes (1)

  • SDNN value

    Standard deviation of all normal nocturnal RR intervals

    9 months

Secondary Outcomes (17)

  • Heart rate variability parameters

    9 months

  • Heart rate variability parameters

    9 months

  • Heart rate variability parameters

    9 months

  • Baroreflex sensitivity (BRS)

    9 months

  • Maximum oxygen uptake (VO2max)

    9 months

  • +12 more secondary outcomes

Study Arms (3)

Brisk walking 1

EXPERIMENTAL

1 time a week of 9 months brisk walking

Behavioral: Brisk walking

Brisk walking 3

EXPERIMENTAL

3 times a week of 9 months brisk walking

Behavioral: Brisk walking

Control group

NO INTERVENTION

No brisk walking session

Interventions

Brisk walkingBEHAVIORAL

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

Brisk walking 1Brisk walking 3

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

French Loire Mutuality

Saint-Etienne, 42100, France

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • David HUPIN, MD, PhD

    University Hospital of Saint-Etienne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David HUPIN, MD, PhD

CONTACT

0477829109david.hupin@chu-st-etienne.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2017

First Posted

October 5, 2017

Study Start

June 1, 2016

Primary Completion

August 31, 2018

Study Completion

November 30, 2019

Last Updated

May 9, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)