EFFECT OF A PHYSICAL EXERCISE PROGRAM ON FUNCTIONAL CAPACITY AND FALL PREVENTION IN PSYCHIATRIC INPATIENT CARE
14 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
46
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brésil, 90410-000
- Hospital de Clinicas de Porto Alegre
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: 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.
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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.
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Aucune intervention: Control Group
The control group will follow the existing physical activity routine.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Functional capacity
Délai: 15 days
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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.
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15 days
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Calf Circumference
Délai: 15 days
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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.
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15 days
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Fall Risk Score
Délai: 15 days
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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.
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15 days
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Paolo P Lamb, Hospital de Clinicas de Porto Alegre
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 octobre 2026
Achèvement primaire (Estimé)
15 décembre 2026
Achèvement de l'étude (Estimé)
20 février 2027
Dates d'inscription aux études
Première soumission
14 septembre 2026
Première soumission répondant aux critères de contrôle qualité
14 septembre 2026
Première publication (Réel)
18 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-0204
Plan pour les données individuelles des participants (IPD)
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NON
Informations sur les médicaments et les dispositifs, documents d'étude
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