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

NCT07827547 | Not Yet Recruiting

• 1 other identifier: 2026-0204
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fall Risk

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Fall Risk Score

  15 days

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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

Control Group

NO INTERVENTION

The control group will follow the existing physical activity routine.

Interventions

Intervention OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90410-000, Brazil

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Paolo P Lamb

  Hospital de Clinicas de Porto Alegre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): February 20, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)