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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorUniversity Hospital, Strasbourg, France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Osteoarticular limitations compromising muscle strengthening,

Unstabilized cardiac pathologies,

Unstabilized chronic pathologies,

Unstabilized ventricular and supraventricular rhythm disorders or ECG abnormalities at the inclusion visit,

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

    Other intervention

    Physical activity with only muscle strengthening

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: rehabilitation with muscle strengthening + Oral Nutritional SupplementsExperimental treatment 1 intervention
Group B: standard rehabilitation +/- Oral Nutritional SupplementsActive comparator 1 intervention

Trial outcomes

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.

Time frame
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)

Time frame
2 years

Other outcomes

Sponsors and contacts

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