Autonomy of Older PeoplePREPADNCT03992222
Prevention of the Older Adult's Loss of Autonomy at Home Through a Targeted Physical Exercise Program
A study testing Physical exercise programs PEP targeted on appropriate muscle strengthening devices allows in people with Autonomy of Older People, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Autonomy of Older People
- What is being tested?
- Physical exercise programs PEP targeted on appropriate muscle strengthening devices allows
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2019to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of the Older Adult's Loss of Autonomy at Home Through a Physical Exercise Program Targeted at Adapted Muscle Strengthening Devices
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.
Read the detailed 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.
- Conditions
- Autonomy of Older People
- Being tested
- Physical exercise programs PEP targeted on appropriate muscle strengthening devices allows
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise programs PEP targeted on appropriate muscle strengthening devices allowsDevice
administration of a Physical exercise program for 24 weeks.The participants will be followed at the 24 and 52nd weeks.
| Study group | Role | What they receive |
|---|---|---|
| administration of a physical exercise programme | Experimental | administration of a Physical exercise program for 24 weeks. Receives: Device: Physical exercise programs PEP targeted on appropriate muscle strengthening devices allows |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start19 Jan 2019
- Primary completionJul 2022 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomy of Older PeopleStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique FRANCOIS, Dr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992222
- Sponsor's protocol ID
- K 170 919
- Acronym
- PREPAD
- Status last verified
- Jan 2019
- First submitted
- 18 Jun 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of the Older Adult's Loss of Autonomy at Home Through a Physical Exercise Program Targeted at Adapted Muscle Strengthening Devices
- ClinicalTrials.gov ID
- NCT03992222
- Acronym / sponsor ID
- PREPAD / K 170 919
- Conditions
- Autonomy of Older People
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 19 Jan 2019 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| administration of a physical exercise programme | Experimental | Device: Physical exercise programs PEP targeted on appropriate muscle strengthening devices allowsadministration of a Physical exercise program for 24 weeks. |
| control | No intervention | – |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical exercise programs PEP targeted on appropriate muscle strengthening devices allowsadministration of a Physical exercise program for 24 weeks.The participants will be followed at the 24 and 52nd weeks. | Device | administration of a physical exercise programme |
Primary outcome
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.
Time frame: 12 months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Véronique FRANCOIS, Dr principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise programs PEP targeted on appropriate muscle strengthening devices allows in people with Autonomy of Older People, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.