NCT03992222

Brief Summary

Physical exercise program (PEP) have demonstrated their benefit to the health of older people. They are effective in functional performance and in the incidence and severity of falls. We hypothesize that intervention with targeted Physical exercise programs PEP on appropriate muscle strengthening devices allows, through its action on the muscle, to slow down the loss of autonomy in the elderly living in the home. Our main objective is to evaluate the impact of a PEP, targeted on adapted muscle strengthening devices, on the loss of autonomy for the acts of daily life in the person aged over 70 living at home.

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
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

July 9, 2019

Status Verified

January 1, 2019

Enrollment Period

3.4 years

First QC Date

June 18, 2019

Last Update Submit

July 5, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of people without activities of daily living (LDA) assessed by the 12-month Katz questionnaire in the intervention group compared to the control group.

    To evaluate the impact of targeted PEEP on appropriate muscle strengthening devices, on the loss of autonomy for the acts of daily life in the person over 70 years old living at home

    12 months

Study Arms (2)

administration of a physical exercise programme

EXPERIMENTAL

administration of a Physical exercise program for 24 weeks.

Device: Physical exercise programs PEP targeted on appropriate muscle strengthening devices allows

control

NO INTERVENTION

Interventions

administration of a Physical exercise program for 24 weeks.The participants will be followed at the 24 and 52nd weeks.

administration of a physical exercise programme

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • People over 70 years old
  • Living at home
  • With at least one instrumental activity of altered daily life (a disturbed criterion on the IADL scale) and making a request to set up a housekeeper.
  • Major, able to give their consent
  • Having signed the informed consent
  • Affiliation to a social security scheme,

You may not qualify if:

  • Surgical procedure within 6 months on the hip or knee,
  • myocardial infarction or cerebrovascular accident diagnosed within 6 months,
  • Respiratory insufficiency requiring long-term oxygen therapy
  • Heart failure requiring hospitalization in the previous month or considered severe by the cardiologist
  • Known or disabling muscle or joint pathology
  • Subject benefiting from rehabilitation through physiotherapy sessions in progress or not wishing to stop physical exercise workshops
  • Subject already in loss of autonomy for the ADL
  • Life expectancy of less than 6 months any cause combined

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital René Muret

Sevran, France

Location

Study Officials

  • Véronique FRANCOIS, Dr

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 18, 2019

First Posted

June 20, 2019

Study Start

January 19, 2019

Primary Completion

July 1, 2022

Study Completion

July 1, 2023

Last Updated

July 9, 2019

Record last verified: 2019-01

Locations