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Effect of Muscle Strengthening on the Incidence of Psychomotor Disadaptation Syndrome in Elderly Persons (RM-SDP)

Primary Purpose

Psychomotor Disadaptation Syndrome, Post-fall Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
rehabilitation with muscle strengthening + Oral Nutritional Supplements
rehabilitation with muscle strengthening
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Psychomotor Disadaptation Syndrome focused on measuring elderly person, muscle strengthening

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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,
  • 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.

Sites / Locations

  • Service de Gériatrie aigue - CHU de Strasbourg - France

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

rehabilitation with muscle strengthening + Oral Nutritional Supplements

standard rehabilitation +/- Oral Nutritional Supplements

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of psychomotor disadaptation syndrome complications following a fall
the number of falls, repeat falls (≥ 2 falls in a 12-month period)

Full Information

First Posted
February 2, 2022
Last Updated
December 9, 2022
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT05237609
Brief Title
Effect of Muscle Strengthening on the Incidence of Psychomotor Disadaptation Syndrome in Elderly Persons
Acronym
RM-SDP
Official Title
Effect of Muscle Strengthening on the Incidence of Psychomotor Disadaptation Syndrome After a Fall in Elderly Persons
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychomotor Disadaptation Syndrome, Post-fall Syndrome
Keywords
elderly person, muscle strengthening

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rehabilitation with muscle strengthening + Oral Nutritional Supplements
Arm Type
Experimental
Arm Description
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.
Arm Title
standard rehabilitation +/- Oral Nutritional Supplements
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
rehabilitation with muscle strengthening + Oral Nutritional Supplements
Intervention Description
Combination of protein intake and muscle strengthening exercises for the improvement of walking capacities, patients in the experimental group
Intervention Type
Other
Intervention Name(s)
rehabilitation with muscle strengthening
Intervention Description
Physical activity with only muscle strengthening
Primary Outcome Measure Information:
Title
Incidence of psychomotor disadaptation syndrome
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Incidence of psychomotor disadaptation syndrome complications following a fall
Description
the number of falls, repeat falls (≥ 2 falls in a 12-month period)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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. Exclusion criteria: 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, 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elise SCHMITT
Phone
+33 3 88 11 58 84
Email
elise.schmitt@chru-strasbourg.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Maxence MEYER
Phone
+33 3 88 11 56 16
Email
maxence.meyer@chru-strasbourg.fr
Facility Information:
Facility Name
Service de Gériatrie aigue - CHU de Strasbourg - France
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elise SCHMITT
Phone
+33 3 88 11 58 84
Email
elise.schmitt@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Elise SCHMITT
First Name & Middle Initial & Last Name & Degree
Maxence MEYER

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Muscle Strengthening on the Incidence of Psychomotor Disadaptation Syndrome in Elderly Persons

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