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

NCT07156448 | Completed

• 2 other identifiers: CE21145BTCVGH-1107402B
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hospitalization; Aged 65 Years or Older; Activities of Daily Living; Depression; Quality of Life; Spirituality

Keywords

Exercise intervention; Physical function; Mobility; Timed Up and Go; Barthel Index; Functional Reach Test; Handgrip strength; Geriatric Depression Scale; EQ-5D-3L; EQ-VAS; Spiritual Index of Well-Being; Spiritual well-being; Internal medicine ward; Older patients

Outcome Measures

Primary Outcomes (6)

• Timed Up and Go (TUG)

  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.

  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)

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

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

• Functional Reach Test (FRT)

  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.

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

• Handgrip strength (HGS)

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

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

• Barthel Index (BI)

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

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

• 5-item Geriatric Depression Scale (GDS-5)

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

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

Secondary Outcomes (3)

• 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)

Study Arms (2)

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.

Behavioral: Multicomponent Exercise Program

Control Group

NO INTERVENTION

Participants received usual hospital care without additional structured exercise intervention.

Interventions

Multicomponent Exercise Program BEHAVIORAL

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.

Exercise Intervention Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taichung City, 40705, Taiwan

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomly assigned to either the intervention group, which received the exercise program, or the control group, which received usual care. Both groups were assessed at baseline and after the intervention

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 5, 2025
• Study Start: July 9, 2021
• Primary Completion: March 5, 2022
• Study Completion: March 5, 2022
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 6 months after publication and ending 5 years thereafter
• Access Criteria: Researchers must submit a methodologically sound research proposal and sign a Data Use Agreement. Requests will be reviewed by the principal investigator to ensure compliance with ethical and legal requirements.

Locations

TW (1)