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

2026년 9월 14일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

46

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
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.
간섭 없음: Control Group
The control group will follow the existing physical activity routine.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Functional capacity
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Fall Risk Score
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 책임자: Paolo P Lamb, Hospital de Clinicas de Porto Alegre

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 1일

기본 완료 (추정된)

2026년 12월 15일

연구 완료 (추정된)

2027년 2월 20일

연구 등록 날짜

최초 제출

2026년 9월 14일

QC 기준을 충족하는 최초 제출

2026년 9월 14일

처음 게시됨 (실제)

2026년 9월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 14일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2026-0204

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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