Psychomotor Disadaptation SyndromeRM-SDPNCT05237609
Effect of Muscle Strengthening on the Incidence of Psychomotor Disadaptation Syndrome in Elderly Persons
A study testing rehabilitation with muscle strengthening + Oral Nutritional Supplements and rehabilitation with muscle strengthening in people with Psychomotor Disadaptation Syndrome and Post-fall Syndrome, run by University Hospital, Strasbourg, France at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Psychomotor Disadaptation Syndrome, Post-fall Syndrome
- What is being tested?
- rehabilitation with muscle strengthening + Oral Nutritional Supplements and rehabilitation with muscle strengthening
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2023to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Subject over 70 years of age at the time of signing the consent, with no upper limit,
- 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.
Who cannot join
- Osteoarticular limitations compromising muscle strengthening,
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Service de Gériatrie aigue - CHU de Strasbourg - France
Strasbourg, 67091
Elise SCHMITT, +33 3 88 11 58 84, elise.schmitt@chru-strasbourg.fr
Elise SCHMITT
About this study
Official title: Effect of Muscle Strengthening on the Incidence of Psychomotor Disadaptation Syndrome After a Fall in Elderly Persons
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.
Read the detailed 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.
- Being tested
- rehabilitation with muscle strengthening + Oral Nutritional Supplements, rehabilitation with muscle strengthening
- Keywords
- elderly person, muscle strengthening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitation with muscle strengthening + Oral Nutritional SupplementsDietary supplement
Combination of protein intake and muscle strengthening exercises for the improvement of walking capacities, patients in the experimental group
rehabilitation with muscle strengtheningOther
Physical activity with only muscle strengthening
| Study group | Role | What they receive |
|---|---|---|
| rehabilitation with muscle strengthening + Oral Nutritional Supplements | Experimental | 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. Receives: Dietary Supplement: rehabilitation with muscle strengthening + Oral Nutritional Supplements |
| standard rehabilitation +/- Oral Nutritional Supplements | Active comparator | 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. Receives: Other: rehabilitation with muscle strengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of psychomotor disadaptation syndrome
The primary endpoint will be the incidence of psychomotor disadaptation syndrome after a fall in subjects over 70 years of age who are receiving or not receiving adapted muscle strengthening. The determination of the psychomotor disadaptation syndrome is clinical and includes retropulsion, fear of falling, fear of verticality, oppositional hypertonia or an abrupt break with the previous functional state without obvious organic cause. It can be identified after of a fall by the family, by the nurses and physiotherapists in charge of the participants, by the doctors and physiotherapists of the HDJ, by their GP, by the emergency physicians if the patient is referred to the emergency room, by the hospital doctors in case of hospitalization, and will be identified during the visits at 1 and 2 years and during the telephone calls every 4 months.
Measured: 2 years
Secondary outcomes (1)
Incidence of psychomotor disadaptation syndrome complications following a fall
the number of falls, repeat falls (≥ 2 falls in a 12-month period)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study startJan 2023 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychomotor Disadaptation SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237609
- Sponsor's protocol ID
- 8455
- Acronym
- RM-SDP
- Status last verified
- Dec 2022
- First submitted
- 2 Feb 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Muscle Strengthening on the Incidence of Psychomotor Disadaptation Syndrome After a Fall in Elderly Persons
- ClinicalTrials.gov ID
- NCT05237609
- Acronym / sponsor ID
- RM-SDP / 8455
- Keywords
- elderly person, muscle strengthening
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 14 Feb 2022 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rehabilitation with muscle strengthening + Oral Nutritional Supplements | Experimental | Dietary Supplement: rehabilitation with muscle strengthening + Oral Nutritional SupplementsParticipants 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. |
| standard rehabilitation +/- Oral Nutritional Supplements | Active comparator | Other: rehabilitation with muscle strengtheningThe 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Subject over 70 years of age at the time of signing the consent, with no upper limit,
- 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.
Key exclusion criteria (12 listed)
- Osteoarticular limitations compromising muscle strengthening,
- Unstabilized cardiac pathologies,
- Unstabilized chronic pathologies,
- Unstabilized ventricular and supraventricular rhythm disorders or ECG abnormalities at the inclusion visit,
- Swallowing disorders (CNO)
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 |
|---|---|---|
| rehabilitation with muscle strengthening + Oral Nutritional SupplementsCombination of protein intake and muscle strengthening exercises for the improvement of walking capacities, patients in the experimental group | Dietary supplement | rehabilitation with muscle strengthening + Oral Nutritional Supplements |
| rehabilitation with muscle strengtheningPhysical activity with only muscle strengthening | Other | standard rehabilitation +/- Oral Nutritional Supplements |
Primary outcome
Incidence of psychomotor disadaptation syndrome
Time frame: 2 years
The primary endpoint will be the incidence of psychomotor disadaptation syndrome after a fall in subjects over 70 years of age who are receiving or not receiving adapted muscle strengthening. The determination of the psychomotor disadaptation syndrome is clinical and includes retropulsion, fear of falling, fear of verticality, oppositional hypertonia or an abrupt break with the previous functional state without obvious organic cause. It can be identified after of a fall by the family, by the nurses and physiotherapists in charge of the participants, by the doctors and physiotherapists of the HDJ, by their GP, by the emergency physicians if the patient is referred to the emergency room, by the hospital doctors in case of hospitalization, and will be identified during the visits at 1 and 2 years and during the telephone calls every 4 months.
1 secondary outcome
Incidence of psychomotor disadaptation syndrome complications following a fall
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rehabilitation with muscle strengthening + Oral Nutritional Supplements and rehabilitation with muscle strengthening in people with Psychomotor Disadaptation Syndrome and Post-fall Syndrome, run by University Hospital, Strasbourg, France 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 4 inclusion and 12 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: opening soon, as of the sponsor's last update on 12 Dec 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elise SCHMITT (+33 3 88 11 58 84, elise.schmitt@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of psychomotor disadaptation syndrome (time frame: 2 years). 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 12 Dec 2022.