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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fall Risk
• Intervention / Treatment: Other: Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90410-000
      • Hospital de Clínicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: 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.
No Intervention: Control Group; The control group will follow the existing physical activity routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional capacity	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fall Risk Score	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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Study Director: Paolo P Lamb, Hospital de Clínicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): February 20, 2027

Study Registration Dates

• First Submitted: September 14, 2026
• First Submitted That Met QC Criteria: September 14, 2026
• First Posted (Actual): September 18, 2026

Study Record Updates

• Last Update Posted (Actual): September 18, 2026
• Last Update Submitted That Met QC Criteria: September 14, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Methods
• Other Study ID Numbers: 2026-0204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No