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

NCT05237609 | Not Yet Recruiting

• 1 other identifier: 8455
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychomotor Disadaptation Syndrome; Post-fall Syndrome

Keywords

elderly person; muscle strengthening

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

• Incidence of psychomotor disadaptation syndrome complications following a fall

  2 years

Study Arms (2)

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.

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.

Other: rehabilitation with muscle strengthening

Interventions

rehabilitation with muscle strengthening + Oral Nutritional Supplements DIETARY_SUPPLEMENT

Combination of protein intake and muscle strengthening exercises for the improvement of walking capacities, patients in the experimental group

rehabilitation with muscle strengthening + Oral Nutritional Supplements

rehabilitation with muscle strengthening OTHER

Physical activity with only muscle strengthening

standard rehabilitation +/- Oral Nutritional Supplements

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Osteoarticular limitations compromising muscle strengthening,
• Unstabilized cardiac pathologies,
• Unstabilized chronic pathologies,
• 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.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Gériatrie aigue - CHU de Strasbourg - France

Strasbourg, 67091, France

Location

MeSH Terms

Interventions

Rehabilitation; Dietary Supplements

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Elise SCHMITT

CONTACT

+33 3 88 11 58 84; elise.schmitt@chru-strasbourg.fr

Maxence MEYER

CONTACT

+33 3 88 11 56 16; maxence.meyer@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 14, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2023
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 12, 2022

Record last verified: 2022-12

Locations

FR (1)