Brisk Walking Study in Nursing Home Residents

May 3, 2018 updated by: Clinique Mutualiste Chirurgicale de la Loire

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Saint-Étienne, France, 42100
        • Recruiting
        • French Loire Mutuality
        • Sub-Investigator:
          • Paul CALMELS, MD
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
SDNN value
Time Frame: 9 months
Standard deviation of all normal nocturnal RR intervals
9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heart rate variability parameters
Time Frame: 9 months
Autonomic nervous system balance (RMSSD)
9 months
Heart rate variability parameters
Time Frame: 9 months
Autonomic nervous system balance (LF/HF)
9 months
Heart rate variability parameters
Time Frame: 9 months
Autonomic nervous system balance (Ptot)
9 months
Baroreflex sensitivity (BRS)
Time Frame: 9 months
BRS slope variation measured at rest
9 months
Maximum oxygen uptake (VO2max)
Time Frame: 9 months
Cardiopulmonary exercise testing
9 months
Daily physical activity
Time Frame: 9 months
Actimetry (Actigraph-GT3X)
9 months
Daily physical activity
Time Frame: 9 months
Adult physical activity questionnaire (APAQ)
9 months
Sedentary periods
Time Frame: 9 months
Actimetry (Actigraph GT3X)
9 months
Sedentary periods
Time Frame: 9 months
Adult physical activity questionnaire (APAQ)
9 months
Muscular force
Time Frame: 9 months
Lower limbs maximum voluntary force test measured on force chair
9 months
Muscular endurance
Time Frame: 9 months
Lower limbs endurance test measured on force chair
9 months
Muscular volume gains
Time Frame: 9 months
Lower limbs muscular magnetic resonance imaging (MRI)
9 months
Plasmatic dosages of inflammatory molecules
Time Frame: 9 months
CRP
9 months
Plasmatic dosages of inflammatory molecules
Time Frame: 9 months
TNF alpha
9 months
Plasmatic dosages of inflammatory molecules
Time Frame: 9 months
IL 17
9 months
Cognitive improvements
Time Frame: 9 months
Neuropsychological evaluation with a neuropsychologist.
9 months
Quality of life
Time Frame: 9 months
SF-36 questionnaire
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clinique Mutualiste Chirurgicale de la Loire

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital of Saint-Etienne
University of Lyon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David HUPIN, MD, PhD, University Hospital of Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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