- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07827547
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.
연구 개요
상세 설명
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, 브라질, 90410-000
- Hospital de Clinicas de Porto Alegre
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
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
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 |
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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.
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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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간섭 없음: Control Group
The control group will follow the existing physical activity routine.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Functional capacity
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Fall Risk Score
기간: 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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공동 작업자 및 조사자
수사관
- 연구 책임자: Paolo P Lamb, Hospital de Clinicas de Porto Alegre
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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