Effect of Muscle Strengthening on the Incidence of Psychomotor Disadaptation Syndrome in Elderly Persons
NCT ID: NCT05237609
Last Updated: 2022-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2023-01-31
2027-01-31
Brief Summary
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Detailed Description
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* A medical assessment
* Medical history,
* Significant medical history and assessment of comorbidities using the Charlson score,
* Medications and ONS (Oral Nutritional Supplements),
* Lifestyle,
* Complete clinical examination with orthostatic hypotension test and ECG,
* Cognitive assessment with MMSE,
* Retrieval of latest imaging and biology results.
If and only if the subject has signed his consent, the following measurements will be performed:
* Grip strength using a manometer,
* Gait assessment (gaitride® treadmill).
As in current practice, the patient will then be referred by the investigator to the ABRAPA day hospitals. They will then receive adapted management at the day hospital within 4 to 6 weeks of inclusion.
The intervention will be randomized:
\- Experimental group: rehabilitation with muscle strengthening + ONS
Participants will receive weekly physical therapy sessions for 20 weeks, during their usual follow-up at the day hospital. In addition to the standard treatment, muscle strengthening exercises using elastic bands of varying resistance will be performed. These sessions can be completed by a muscle strengthening session at home during the week, given by a private physiotherapist according to the indication given by a doctor taking care of the patient, during and outside the periods of follow-up at the day hospital. In addition to muscle strengthening, participants will receive a systematic protein intake via Oral Nutritional Supplements (ONS) to improve muscle strength. Compliance with these oral nutritional supplements will be monitored by means of a booklet filled in by the patient or his entourage.
\- Control group: standard rehabilitation +/- ONS
The participants in the control group will receive the usual care at the day hospital, i.e. a rehabilitation program focused on the prevention of falls. The prescription of ONS will be made on a case-by-case basis by the day hospital's physician. If participants require follow-up by a physiotherapist at home, sessions will be prescribed.
After the treatment, participants in the experimental group will be advised to continue the muscle strengthening sessions independently at least once a week. All participants, regardless of their group, who require follow-up by a physiotherapist will benefit from it.
Follow-up will take place for 2 years with data collected every 4 months from the inclusion visit via telephone calls to participants and their families, to the treating physician. A new medical evaluation is planned at 1 year, based on the same model as the screening visit, except for grip strength.
Participants will have a second cycle of 20 sessions at the day hospital in their respective group at the beginning of the second year of follow-up.
The end-of-study visit will take place 2 years after the inclusion visit in the same way as the 1-year visit.
The data collected will concern the onset of psychomotor maladjustment syndrome, the number of falls, severe falls, assessment of functional autonomy during follow-up, hospitalizations, hospitalizations for falls, entry into an institution, deaths from any cause, post-fall deaths.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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rehabilitation with muscle strengthening + Oral Nutritional Supplements
Participants will receive weekly physical therapy sessions for 20 weeks, during their usual follow-up at the day hospital. In addition to the standard treatment, muscle strengthening exercises using elastic bands of varying resistance will be performed. These sessions can be completed by a muscle strengthening session at home during the week, given by a private physiotherapist according to the indication given by a doctor taking care of the patient, during and outside the periods of follow-up at the day hospital. In addition to muscle strengthening, participants will receive a systematic protein intake via Oral Nutritional Supplements (ONS) to improve muscle strength. Compliance with these oral nutritional supplements will be monitored by means of a booklet filled in by the patient or his entourage.
rehabilitation with muscle strengthening + Oral Nutritional Supplements
Combination of protein intake and muscle strengthening exercises for the improvement of walking capacities, patients in the experimental group
standard rehabilitation +/- Oral Nutritional Supplements
The participants in the control group will receive the usual care at the day hospital, i.e. a rehabilitation program focused on the prevention of falls. The prescription of ONS will be made on a case-by-case basis by the day hospital's physician. If participants require follow-up by a physiotherapist at home, sessions will be prescribed.
After the treatment, participants in the experimental group will be advised to continue the muscle strengthening sessions independently at least once a week. All participants, regardless of their group, who require follow-up by a physiotherapist will benefit from it.
rehabilitation with muscle strengthening
Physical activity with only muscle strengthening
Interventions
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rehabilitation with muscle strengthening + Oral Nutritional Supplements
Combination of protein intake and muscle strengthening exercises for the improvement of walking capacities, patients in the experimental group
rehabilitation with muscle strengthening
Physical activity with only muscle strengthening
Eligibility Criteria
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Inclusion Criteria
* History of a fall,
* Subject affiliated with a social health insurance plan, beneficiary or beneficiary's assistant
* Subject able to understand the objectives and risks of the research and to give dated and signed informed consent.
Exclusion Criteria
* Unstabilized cardiac pathologies,
* Unstabilized chronic pathologies,
* Unstabilized ventricular and supraventricular rhythm disorders or ECG abnormalities at the inclusion visit,
* Swallowing disorders (CNO)
* Acute coronary syndrome \< 1 month,
* Unstabilized or oxygen-dependent respiratory failure,
* Cognitive impairment compromising muscle strengthening achievement (MMSE\<22/30),
* Evolving cancers,
* Subject under guardianship or curatorship,
* Severe malnutrition,
* Severe functional limitation.
70 Years
ALL
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Locations
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Service de Gériatrie aigue - CHU de Strasbourg - France
Strasbourg, , France
Countries
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Central Contacts
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Facility Contacts
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Elise SCHMITT
Role: primary
Other Identifiers
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8455
Identifier Type: -
Identifier Source: org_study_id