HospitalizationNCT07156448
Effectiveness of Exercise Intervention on Physical Function, Psychological Health, Quality of Life, and Spiritual Well-Being in Hospitalized Older Patients
A study testing Multicomponent Exercise Program in people with Hospitalization and Aged 65 Years or Older, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hospitalization, Aged 65 Years or Older, Activities of Daily Living
- What is being tested?
- Multicomponent Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Jul 2021to 5 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Hospitalization, Aged 65 Years or Older, Activities of Daily Living, Depression, Quality of Life, Spirituality
- Being tested
- Multicomponent Exercise Program
- 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
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent Exercise ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Multicomponent Exercise Program |
| Control Group | No intervention | Participants received usual hospital care without additional structured exercise intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Assesses five health domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) on three severity levels.
Measured: 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)
Self-rated health status from 0 (worst imaginable) to 100 (best imaginable).
Measured: 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)
12-item questionnaire with two subscales (self-efficacy and life scheme), scored on a 5-point Likert scale. Higher scores reflect poorer spiritual well-being.
Measured: Baseline (Day 2 of hospitalization) and at discharge (within 24 hours prior to hospital discharge, average length of stay 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start9 Jul 2021
- Primary completion5 Mar 2022
- Study completion5 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HospitalizationStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156448
- Sponsor's protocol ID
- CE21145B
- Other IDs
- TCVGH-1107402B
- Status last verified
- Sep 2025
- First submitted
- 20 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the published results, including baseline characteristics and all primary and secondary outcome measures, will be shared. A data dictionary will be provided to describe variable definitions. Data will be available upon reasonable request after publication.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Exercise Intervention on Physical Function, Psychological Health, Quality of Life, and Spiritual Well-Being in Hospitalized Older Patients
- ClinicalTrials.gov ID
- NCT07156448
- Acronym / sponsor ID
- CE21145B
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 5 Mar 2022 (actual)
- Study completion
- 5 Mar 2022 (actual)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention Group | Experimental | Behavioral: Multicomponent Exercise ProgramParticipants received a structured exercise program during hospitalization, including resistance training, stretching, and walking, delivered five times per week for 30 minutes per session. |
| Control Group | No intervention | –Participants received usual hospital care without additional structured exercise intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent Exercise ProgramParticipants 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. | Behavioural | Exercise Intervention Group |
Primary outcome
Timed Up and Go (TUG)
Time frame: 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)
Time frame: 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
Functional Reach Test (FRT)
Time frame: 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)
Time frame: 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.
Barthel Index (BI)
Time frame: 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.
5-item Geriatric Depression Scale (GDS-5)
Time frame: 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.
3 secondary outcomes
EuroQol 5-Dimension 3-Level (EQ-5D-3L)
Time frame: 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)
Time frame: 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)
Time frame: Baseline (Day 2 of hospitalization) and at discharge (within 24 hours prior to hospital discharge, average length of stay 10 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the published results, including baseline characteristics and all primary and secondary outcome measures, will be shared. A data dictionary will be provided to describe variable definitions. Data will be available upon reasonable request after publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Exercise Program in people with Hospitalization and Aged 65 Years or Older, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (TUG) (time frame: Baseline (Day 2 of hospitalization) and at discharge (within 24 hours prior to hospital discharge, average length of stay 10 days)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.