Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05237609 |
| Other study ID # |
8455 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2023 |
| Est. completion date |
January 2027 |
Study information
| Verified date |
December 2022 |
| Source |
University Hospital, Strasbourg, France |
| Contact |
Elise SCHMITT |
| Phone |
+33 3 88 11 58 84 |
| Email |
elise.schmitt[@]chru-strasbourg.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The post-fall syndrome or psychomotor disadaptation syndrome can be considered as a
complication of a fall and can lead to a total loss of autonomy. This syndrome remains little
studied, despite its important frequency in acute geriatric services or geriatric
rehabilitation care, and despite its recognized seriousness. Decreased grip strength seems to
be a risk factor for psychomotor disadaptation syndrome in after a fall, which is why we
hypothesize that muscle strengthening adapted to the elderly subject would limit the
appearance of this syndrome. By limiting this risk, it would reduce complications such as
loss of functional independence, but also reduce the number and duration of hospitalization
of elderly patients.
Description:
The participants will be referred by the attending physicians, the physicians of the
emergency department or the conventional hospitalization services of the University Hospital
of Strasbourg to the "fall" consultation held at the Robertsau Hospital in geriatrics.
Participants will be evaluated by experienced geriatricians. As part of their routine care,
participants will receive
- 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.
