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临床试验/NCT07156448
NCT07156448已完成不适用

Effectiveness of Exercise Intervention on Physical Function, Psychological Health, Quality of Life, and Spiritual Well-Being in Hospitalized Older Patients

Taichung Veterans General Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年7月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Timed Up and Go (TUG)

研究概览

简要总结

This study aimed to evaluate the effects of a structured exercise program on physical function, psychological well-being, quality of life, and spiritual well-being in hospitalized older adults. A total of 100 inpatients aged 65 years or older were assigned to either an intervention group or a control group. The intervention group participated in a multicomponent exercise program during hospitalization, including resistance training, stretching, and walking, while the control group received routine care. Assessments were performed before and after the intervention using physical performance tests, questionnaires, and well-being scales. The goal is to determine whether such a program can improve mobility, daily living independence, mood, and overall well-being in older patients during hospitalization.

详细描述

This single-center, parallel-group randomized controlled trial investigated the effects of a structured exercise program on multiple dimensions of health in hospitalized older adults. Eligible participants were adults aged ≥65 years, admitted from the emergency department to two internal medicine wards in a teaching hospital in central Taiwan, able to communicate, capable of standing and walking (with or without assistive devices), and willing to participate in the program.

Participants in the intervention group received a structured, multicomponent exercise program consisting of resistance training, stretching, and walking. The program began on the second day of hospitalization and continued until discharge, with a frequency of five sessions per week. Each session lasted approximately 30 minutes, including about 20 minutes of resistance and stretching exercises targeting major muscle groups through functional movements (e.g., sit-to-stand, leg flexion-extension) and flexibility exercises for the upper arms, back, and posterior legs, performed in 2 to 3 sets of 8 to 12 repetitions. Each session also incorporated approximately 10 minutes of walking, with intensity adjusted according to individual tolerance. All sessions were supervised by trained nurses or physical therapists to ensure correct performance and safety.

The control group received routine inpatient care without structured exercise.

Primary outcomes included measures of physical function (Timed Up and Go test, 6-meter walk test, Functional Reach Test, Handgrip strength, and Barthel Index) and psychological health (5-item Geriatric Depression Scale). Secondary outcomes included quality of life (EQ-5D-3L, EQ Visual Analogue Scale) and spiritual well-being (Spiritual Index of Well-Being). All assessments were conducted at baseline (admission) and before discharge by trained assessors blinded to group allocation.

The study aimed to determine whether implementing a structured exercise program during hospitalization could improve multidimensional health outcomes, and to provide evidence for integrating holistic, non-pharmacological interventions into geriatric inpatient care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessors and data analysts were blinded to group allocation to minimize assessment and analysis bias. Participants and care providers were not blinded due to the nature of the intervention.

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age ≥ 65 years
  • •Able to communicate
  • •Capable of standing and walking (with or without assistive devices)
  • •Willing to participate in both the study and the exercise intervention

排除标准

  • •Impaired consciousness
  • •Acute inflammatory conditions (e.g., gout, acute myocardial infarction, unstable angina, heart failure)
  • •Physician-ordered activity restrictions at admission
  • •Diagnosed psychiatric disorders or history of epilepsy
  • •Severe disability requiring total assistance in daily life

研究组 & 干预措施

Exercise Intervention Group

Experimental

Participants received a structured exercise program during hospitalization, including resistance training, stretching, and walking, delivered five times per week for 30 minutes per session.

干预措施: Multicomponent Exercise Program (Behavioral)

Control Group

No Intervention

Participants received usual hospital care without additional structured exercise intervention.

结局指标

主要结局

Timed Up and Go (TUG)

时间窗: Baseline (Day 2 of hospitalization) and at discharge (within 24 hours prior to hospital discharge, average length of stay 10 days)

Assesses mobility and balance by timing the participant as they rise from a chair, walk 3 meters, turn, walk back, and sit down. Time recorded in seconds; shorter times indicate better performance.

6-meter walk test (6MWT)

时间窗: Baseline (Day 2 of hospitalization) and at discharge (within 24 hours prior to hospital discharge, average length of stay 10 days)

6-meter walk test (6MWT), which measured gait speed, with speeds \<1.0 m/s suggesting reduced independence

Barthel Index (BI)

时间窗: Baseline (Day 2 of hospitalization) and at discharge (within 24 hours prior to hospital discharge, average length of stay 10 days)

Assesses independence in activities of daily living (ADL) on a scale of 0-100; higher scores indicate better function.

Functional Reach Test (FRT)

时间窗: Baseline (Day 2 of hospitalization) and at discharge (within 24 hours prior to hospital discharge, average length of stay 10 days)

Assesses dynamic balance by measuring the maximum forward reach distance beyond arm's length while standing, in centimeters. A reach \<15 cm indicates higher fall risk.

Handgrip strength (HGS)

时间窗: Baseline (Day 2 of hospitalization) and at discharge (within 24 hours prior to hospital discharge, average length of stay 10 days)

Measures maximal grip force using a handheld dynamometer, recorded in kilograms. Cut-offs: \<26 kg (men) and \<18 kg (women) indicate sarcopenia.

5-item Geriatric Depression Scale (GDS-5)

时间窗: Baseline (Day 2 of hospitalization) and at discharge (within 24 hours prior to hospital discharge, average length of stay 10 days)

Self-report questionnaire assessing depressive symptoms. Scores ≥2 suggest probable depression.

次要结局

  • EuroQol 5-Dimension 3-Level (EQ-5D-3L)(Baseline (Day 2 of hospitalization) and at discharge (within 24 hours prior to hospital discharge, average length of stay 10 days))
  • EuroQol Visual Analogue Scale (EQ-VAS)(Baseline (Day 2 of hospitalization) and at discharge (within 24 hours prior to hospital discharge, average length of stay 10 days))
  • Spiritual Index of Well-Being (SIWB)(Baseline (Day 2 of hospitalization) and at discharge (within 24 hours prior to hospital discharge, average length of stay 10 days))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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