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EFFECT OF A PHYSICAL EXERCISE PROGRAM ON FUNCTIONAL CAPACITY AND FALL PREVENTION IN PSYCHIATRIC INPATIENT CARE

14 settembre 2026 aggiornato da: Hospital de Clinicas de Porto Alegre

EFFECT OF A PHYSICAL EXERCISE PROGRAM ON FUNCTIONAL CAPACITY AND FALL PREVENTION IN PSYCHIATRIC INPATIENT CARE: A RANDOMIZED CLINICAL TRIAL

Falls are an important health problem, especially among adults and older people who are hospitalized, because they can cause injuries, increase the length of hospital stay, and make it more difficult to perform daily activities. In psychiatric inpatient units, the risk of falls may be higher due to medication use, changes in attention and thinking, balance difficulties, reduced muscle strength, and lower awareness of the risk of falling.

This study aims to evaluate whether a physical exercise program can help patients hospitalized in a psychiatric unit improve their ability to perform movements and daily activities and reduce their risk of falls. The study will include 46 adult and older patients of both sexes who have a moderate or high risk of falls.

Participants will be randomly divided into two groups. One group will continue with the physical activities that are normally part of the unit's routine. The other group will participate in an organized exercise program, including aerobic exercises, muscle-strengthening exercises, and balance exercises. The exercises will be performed two to three times per week, for at least six sessions.

Before and after the program, assessments will be carried out to evaluate the participants' physical ability and risk of falls. It is expected that the exercises will help patients improve their physical performance and contribute to preventing falls during hospitalization.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Rischio di caduta

Intervento / Trattamento

Altro: Intervention

Descrizione dettagliata

Falls represent an important public health problem, especially among hospitalized adult and older patients, due to the risk of injuries, increased length of hospital stay, loss of functional capacity, and worsening of the clinical condition. In psychiatric inpatient units (PIUs), this risk becomes even more relevant due to factors such as the use of psychotropic medications, cognitive impairments, balance deficits, reduced muscle strength, and low risk perception. Although the benefits of physical exercise on functional capacity are widely described in the literature, studies investigating its direct relationship with fall prevention in hospitalized psychiatric patients are still scarce. In this context, the present study aims to develop and implement a physical exercise program for patients hospitalized in a PIU, evaluating its effects on functional capacity and fall risk. This is a randomized controlled clinical trial, with two arms (control group and intervention group), to be conducted in a PIU of a large hospital in the southern region of Brazil. The sample will consist of 46 adult and older patients of both sexes, classified as having moderate or high risk of falls, according to the SAKp Fall Risk Scale. Participants will be randomized into blocks of six individuals. The control group will follow the unit's usual physical exercise routine, while the intervention group will participate in a systematized program of aerobic, resistance, and balance exercises, performed two to three times per week, totaling at least six sessions. Assessments will be performed before and after the intervention using the Short Physical Performance Battery (SPPB) and Calf Circumference (CC). The primary outcome will be improvement in functional capacity and, as a secondary outcome, reduction in fall risk. It is expected that the intervention will contribute to improving the functional performance of hospitalized patients, assisting in fall prevention.

Tipo di studio

Interventistico

Iscrizione (Stimato)

Fase

Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Brasile
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brasile, 90410-000
    - Hospital de Clinicas de Porto Alegre

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Adulto
Adulto più anziano

Accetta volontari sani

Descrizione

Inclusion Criteria:

Patients hospitalized in a Psychiatric Inpatient Unit;
Adults aged 18 years or older;
SAKp Fall Risk Scale with a moderate risk score (6.5 to 10 points) or high risk (10.5 points or higher);
Clinical and cognitive conditions that allow the performance of physical exercises;
Patients with an expected hospital stay of 12 days or longer, in order to ensure minimum exposure to the proposed intervention;
Agreement to participate in the study by signing the Informed Consent Form.

Exclusion Criteria:

Patients with medical restrictions on the practice of physical exercise will be excluded from the study;
Patients with an acute or unstable clinical condition that prevents the performance of the assessments;
Patients or their legal representative who do not agree to participate or who withdraw from the study at any stage.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Prevenzione
Assegnazione: Randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm Gruppo di partecipanti / Arm Un gruppo o sottogruppo di partecipanti a uno studio clinico che riceve un intervento/trattamento specifico o nessun intervento, secondo il protocollo dello studio.	Intervento / Trattamento Intervento / Trattamento Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.
Comparatore attivo: Intervention Group The intervention group will undergo a systematized physical training program two to three times per week, totaling at least six sessions throughout the hospitalization period, with a duration of 20 to 30 minutes per session.	Altro: Intervention The program will be carried out in the unit's gym and will include aerobic, resistance, and balance exercises. Sessions will begin with 5 to 10 minutes of aerobic exercise on a cycle ergometer, followed by step-up and step-down exercises, lateral stepping, standing hip flexion with ankle weights, squats, and single-leg balance on a balance disc. The exercises will be performed in two sets of 10 repetitions, except for single-leg balance, which will be performed in two 20-second sets. Exercise execution and progression will be adapted to each patient's clinical and functional conditions.
Nessun intervento: Control Group The control group will follow the existing physical activity routine.

Gruppo di partecipanti / Arm

Intervento / Trattamento

Comparatore attivo: Intervention Group

The intervention group will undergo a systematized physical training program two to three times per week, totaling at least six sessions throughout the hospitalization period, with a duration of 20 to 30 minutes per session.

Altro: Intervention

The program will be carried out in the unit's gym and will include aerobic, resistance, and balance exercises. Sessions will begin with 5 to 10 minutes of aerobic exercise on a cycle ergometer, followed by step-up and step-down exercises, lateral stepping, standing hip flexion with ankle weights, squats, and single-leg balance on a balance disc. The exercises will be performed in two sets of 10 repetitions, except for single-leg balance, which will be performed in two 20-second sets. Exercise execution and progression will be adapted to each patient's clinical and functional conditions.

Nessun intervento: Control Group

The control group will follow the existing physical activity routine.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Functional capacity Lasso di tempo: 15 days	The primary outcome is an improvement in functional capacity, assessed using the Short Physical Performance Battery (SPPB). The instrument evaluates three components: balance, lower-limb strength, and gait performance. The total score ranges from 0 to 12 points and is classified as follows: 0-3 points: disability; 4-6 points: low physical performance; 7-9 points: moderate physical performance; and 10-12 points: good physical performance.	15 days
Calf Circumference Lasso di tempo: 15 days	Calf circumference is used to assess muscle mass and predict physical and functional impairments. The cutoff point for this measurement ranges from 31-35 cm in women and 33-34 cm in men. The measurement is performed with the patient seated, at the largest circumference of the calf, with the leg positioned at a 90° angle.	15 days

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Fall Risk Score Lasso di tempo: 15 days	Fall risk will be measured using the Severo-Almeida-Kuchembecker (SAK) Fall Risk Scale, which comprises seven variables: disorientation/confusion, frequent urination, gait impairment, absence of a companion, postoperative status and/or undergoing electroconvulsive therapy (ECT), number of medications administered within 24 hours, and history of falls. The scoring ranges are: 0-6, low fall risk; 6.5-10, moderate risk; and ≥10.5, high risk. The SAK will be administered immediately after the patient is accepted into the study and again right after the six sessions of the exercise program.	15 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigatori

Direttore dello studio: Paolo P Lamb, Hospital de Clinicas de Porto Alegre

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

15 dicembre 2026

Completamento dello studio (Stimato)

20 febbraio 2027

Date di iscrizione allo studio

Primo inviato

14 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

14 settembre 2026

Primo Inserito (Effettivo)

18 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

2026-0204

Piano per i dati dei singoli partecipanti (IPD)

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Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

EFFECT OF A PHYSICAL EXERCISE PROGRAM ON FUNCTIONAL CAPACITY AND FALL PREVENTION IN PSYCHIATRIC INPATIENT CARE