Prevention of the Older Adult's Loss of Autonomy at Home Through a Targeted Physical Exercise Program

Autonomy of Older People Clinical Trial

— PREPAD  

Official title:

Prevention of the Older Adult's Loss of Autonomy at Home Through a Physical Exercise Program Targeted at Adapted Muscle Strengthening Devices

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03992222
• Other study ID #: K 170 919
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 19, 2019
• Est. completion date: July 2023

Study information

• Verified date: January 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The elderly will be identified during their call in the home centers of the town halls to get a housekeeper. After information, inclusion and randomization into two groups in the consultation site, the intervention group volunteers will follow the PEP for 24 weeks; the control group volunteers will receive a counseling booklet. Both groups will be followed at week 24 and 52.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 280
• Est. completion date: July 2023
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• 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,

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Autonomy of Older People

Intervention

Device:
• Physical exercise programs PEP targeted on appropriate muscle strengthening devices allows
administration of a Physical exercise program for 24 weeks.The participants will be followed at the 24 and 52nd weeks.

Locations

Country	Name	City	State
France	Hopital René Muret	Sevran

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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