Older AdultsNCT05476471
The Effectiveness of Health Promotion Programs on the Pre-frail Individuals
A study testing multicomponent exercise training program in people with Older Adults, run by Shu-Hung Chang at 1 site in Taiwan.
Trial summary
This pilot study aimed to examine the efficacy of a home-based multicomponent exercise training program in older community- dwellers during to the Coronavirus Disease 2019. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Older Adults
- What is being tested?
- multicomponent exercise training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2020to 31 May 2020
- 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 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- older adult with age ≥ 60 years
- community-dwelling
- no hearing and visual acuity difficulties
Who cannot join
- Unconscious
- Cognitive impairment or dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Short Effectiveness of Self-Management Skills and Health Promotion Programs on the Health Status of the Pre-frail Individuals in the Communities
This pilot study aimed to examine the efficacy of a home-based multicomponent exercise training program in older community- dwellers during to the Coronavirus Disease 2019.
Read the detailed description
This pilot study aimed to examine the efficacy of a home-based multicomponent exercise training program in older community- dwellers during to the Coronavirus Disease 2019.
Design: A two-arm parallel cluster randomized controlled trial. Older adults ≥60 years old were recruited from eight community units in northern Taiwan. One-hundred and sixty-seven eligible subjects consented to participate in the study. Community units were randomly assigned to either an intervention arm (n=82) or a control arm (n=87). The intervention consisted of one 60-minutes group exercise session once a week in first 8 weeks, and self-management in next 8 weeks. The control arm received an education leaflet. Assessments were performed at baseline and 16 weeks for physical activity, physical performance, and pre-frailty rate. Analysis of covariance or chi-square test adjusted for pretest evaluated the differences between the two study arms.
- Conditions
- Older Adults
- Being tested
- multicomponent exercise training program
- Keywords
- multicomponent exercise training, older adults, physical activity, physical performance, Pre-frailty, Coronavirus Disease 2019 pandemic
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multicomponent exercise training programBehavioural
One supervised 60 minutes training sessions per week were organized combining warm-up, speed-walking, resistance exercise, static and dynamic balance. Supervised walking sessions were for 10-20 minutes at a target intensity of 13-15 on the Borg scale. Thereafter, 10 resistance exercises targeting lower body, trunk and upper body muscles were performed with elastic band. In addition, participants were instructed to accumulate 150 minutes per week of moderate intensity aerobic activity in bouts of at least 10 minutes, and at least 2-3 days all major muscle groups training.
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Experimental | The intervention consisted of one 60-minutes group exercise session once a week in first 8 weeks, and self-management in next 8 weeks Receives: Behavioral: multicomponent exercise training program |
| control arm | No intervention | The control arm received an education leaflet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
International Physical Activity Questionnaire (IPAQ)
Measured: 4 month follow up
short physical performance battery
sit-to-stand, standing balance, and gait-speed
Measured: 4 month follow up
Frailty
Frailty measurement used study of osteoporotic fracture index (SOF)
Measured: 4 month follow up
Secondary outcomes (3)
upper limb muscle strength
hand-grip strength
Measured: 4 month follow up
static balance ability
single-leg standing with the eyes open
Measured: 4 month follow up
physical agility and dynamic balance ability
Timed-Up and Go and Functional Reach Test
Measured: 4 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start1 Jan 2020
- Primary completion1 Jan 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention consisted of one 60-minutes group exercise session once a week in first 8 weeks, and self-management in next 8 weeks. The control arm received an education leaflet.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shu-Hung Chang
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Responsible party
- Sponsor-investigator, Shu-Hung Chang, Chang Gung University of Science and Technology
- Investigators
- Shu-Hung Chang, Ph. D, Principal investigator, Chang Gung University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476471
- Sponsor's protocol ID
- ZRRPF3J0031
- Status last verified
- Jul 2022
- First submitted
- 22 Jul 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chang SH, Chiang CC, Chien NH. Efficacy of a multicomponent exercise training program intervention in community-dwelling older adults during the COVID-19 pandemic: A cluster randomized controlled trial. Geriatr Nurs. 2023 Jan-Feb;49:148-156. doi: 10.1016/j.gerinurse.2022.11.019. Epub 2022 Dec 16.
PubMed 36528997
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Short Effectiveness of Self-Management Skills and Health Promotion Programs on the Health Status of the Pre-frail Individuals in the Communities
- ClinicalTrials.gov ID
- NCT05476471
- Acronym / sponsor ID
- ZRRPF3J0031
- Conditions
- Older Adults
- Keywords
- multicomponent exercise training, older adults, physical activity, physical performance, Pre-frailty, Coronavirus Disease 2019 pandemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Shu-Hung ChangUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 27 Jul 2022 (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 pilot study aimed to examine the efficacy of a home-based multicomponent exercise training program in older community- dwellers during to the Coronavirus Disease 2019.
Detailed description
This pilot study aimed to examine the efficacy of a home-based multicomponent exercise training program in older community- dwellers during to the Coronavirus Disease 2019.
Design: A two-arm parallel cluster randomized controlled trial. Older adults ≥60 years old were recruited from eight community units in northern Taiwan. One-hundred and sixty-seven eligible subjects consented to participate in the study. Community units were randomly assigned to either an intervention arm (n=82) or a control arm (n=87). The intervention consisted of one 60-minutes group exercise session once a week in first 8 weeks, and self-management in next 8 weeks. The control arm received an education leaflet. Assessments were performed at baseline and 16 weeks for physical activity, physical performance, and pre-frailty rate. Analysis of covariance or chi-square test adjusted for pretest evaluated the differences between the two study arms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The intervention consisted of one 60-minutes group exercise session once a week in first 8 weeks, and self-management in next 8 weeks. The control arm received an education leaflet.
| Arm | Type | Receives |
|---|---|---|
| intervention arm | Experimental | Behavioral: multicomponent exercise training programThe intervention consisted of one 60-minutes group exercise session once a week in first 8 weeks, and self-management in next 8 weeks |
| control arm | No intervention | –The control arm received an education leaflet. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- older adult with age ≥ 60 years
- community-dwelling
- no hearing and visual acuity difficulties
Key exclusion criteria (2 listed)
- Unconscious
- Cognitive impairment or dementia
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 training programOne supervised 60 minutes training sessions per week were organized combining warm-up, speed-walking, resistance exercise, static and dynamic balance. Supervised walking sessions were for 10-20 minutes at a target intensity of 13-15 on the Borg scale. Thereafter, 10 resistance exercises targeting lower body, trunk and upper body muscles were performed with elastic band. In addition, participants were instructed to accumulate 150 minutes per week of moderate intensity aerobic activity in bouts of at least 10 minutes, and at least 2-3 days all major muscle groups training. | Behavioural | intervention arm |
Primary outcome
Physical activity
Time frame: 4 month follow up
International Physical Activity Questionnaire (IPAQ)
short physical performance battery
Time frame: 4 month follow up
sit-to-stand, standing balance, and gait-speed
Frailty
Time frame: 4 month follow up
Frailty measurement used study of osteoporotic fracture index (SOF)
3 secondary outcomes
upper limb muscle strength
Time frame: 4 month follow up
static balance ability
Time frame: 4 month follow up
physical agility and dynamic balance ability
Time frame: 4 month follow up
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 27 Jul 2022.
- Derived from this study: PubMed 36528997Chang SH, Chiang CC, Chien NH. Efficacy of a multicomponent exercise training program intervention in community-dwelling older adults during the COVID-19 pandemic: A cluster randomized controlled trial. Geriatr Nurs. 2023 Jan-Feb;49:148-156. doi: 10.1016/j.gerinurse.2022.11.019. Epub 2022 Dec 16.
- Individual participant dataSharing planned: No
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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.
Shu-Hung Chang, Ph. D principal investigator
Chang Gung University of Science and Technology
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 training program in people with Older Adults, run by Shu-Hung Chang 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 3 inclusion and 2 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 27 Jul 2022. 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?
Physical activity (time frame: 4 month follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05476471, which also lists 1 linked publication.
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 27 Jul 2022.