FrailtyNCT04481438
Effects of Acupunch Exercises on the Frail Older Adults in Long-Term Care Facilities
A study testing Acupunch Exercises in people with Frailty and Exercise, run by Chang Gung Memorial Hospital at 10 sites in Taiwan.
Trial summary
Frailty is a complex elderly problem and a precursor of functional degradation in elder adults. The aim of this study will to test the effects of acupunch exercises on the frail older adults in long-term care facilities. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- Acupunch Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 10 sitesTaiwan
- Study dates
- 24 Mar 2020to 24 Mar 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- frail older adults
- aged 65 and above
- had lived in the long-term care facilities more than 3 months
Who cannot join
- dementia patient
- psychiatric patient
- spinal cord injury patient
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Taiwan10 sites
Nursing Home
Chaozhou, Pingtung, 920
Conservation Center
Daliao, Kaohsiung, 831
Elderly Care Center
Fongshan District, Kaohsiung, 830
Nursing Home
Gangshan, Kaohsiung, 820
Nursing Home
Pingtung City, Pingtung City, 900
Nursing Home
Pingtung City, 900
Senior Citizens' Home
Pingtung City, 900
Elderly Care Center
Renwu, Kaohsiung City, 833
Nursing Home
Sanmin, Kaohsiung, 807
Citizens' Home
Yanchao, Kaohsiung City, 824
About this study
Frailty is a complex elderly problem and a precursor of functional degradation in elder adults. The aim of this study will to test the effects of acupunch exercises on the frail older adults in long-term care facilities.
Read the detailed description
Frailty is a complex elderly problem and a precursor of functional degradation in elder adults. The cause of frailty is multifactorial. Regular exercise intervension could improve frailty condition and general functional fitness. The acupunch exercise program was developed based on Jing-Luo theory of tranditional Chinese Medicine. The aim of this study will to test the effects of acupunch exercises on the frail older adults in long-term care facilities.
- Being tested
- Acupunch Exercises
- Keywords
- Acupunch exercises, Frailty, long-term care facilities
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupunch ExercisesOther
The acupunch exercise program was developed based on Jing-Luo theory of tranditional Chinese Medicine. The experiment group will receive Acupunch exercise for 40 minute sessions, 3 times a week, for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| exercise group | Experimental | exercise group will receive acupunch exercise Receives: Other: Acupunch Exercises |
| control group | No intervention | control group will maintain the regular activities of their original daily lives |
What is being measured
The primary outcome is the main question the study is designed to answer.
handgrip strength
handgrip strength measured by the Digital Handgrip Dynamometer (in kilograms)
Measured: 24 weeks
upper limb muscle endurance
upper limb muscle endurance measured by the Arm Curl Test in times per 30 seconds
Measured: 24 weeks
lower limb muscle endurance
lower limb muscle endurance measured by the Chair-to-Stand Test in times per 30 seconds
Measured: 24 weeks
lung function
lung function measured by Peak Flow Meter (in liters)
Measured: 24 weeks
upper body flexibility
upper body flexibility measured by the Back Scratch Test( in centimeters)
Measured: 24 weeks
forward flexion
forward flexion measured by the Chair Sit-and-Reach Test( in centimeters)
Measured: 24 weeks
shoulder joint flexion
shoulder joint flexion measured by protractor( in degree)
Measured: 24 weeks
shoulder joint abduction
shoulder joint abduction measured by protractor( in degree)
Measured: 24 weeks
Secondary outcomes (1)
frailty status
evaluated based on the guidelines of the SOF Research Group
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start24 Mar 2020
- Primary completion24 Mar 2021
- Study completion24 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chia-Pei Chou, Chang Gung Memorial Hospital
- Investigators
- Chia-Pei Chou, MD, Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481438
- Sponsor's protocol ID
- 201900696B0
- Status last verified
- Sep 2021
- First submitted
- 14 Jul 2020
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: for personal privacy reason
Publications
Hsiao CY, Chen KM, Tsai HY, Huang HT, Cheng YY, Tsai AY. Self-Perceived Health and Sleep Quality of Community Older Adults after Acupunch Exercises. Am J Geriatr Psychiatry. 2018 May;26(5):511-520. doi: 10.1016/j.jagp.2018.01.199. Epub 2018 Jan 31.
PubMed 29433845Kojima G. Prevalence of Frailty in Nursing Homes: A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2015 Nov 1;16(11):940-5. doi: 10.1016/j.jamda.2015.06.025. Epub 2015 Aug 6.
PubMed 26255709Chou CP, Chen KM, Tung HT, Belcastro F, Hsu HF. Physical fitness and frailty status of frail older adults in long-term care facilities after acupunch exercises: A cluster-randomized controlled trial. Exp Gerontol. 2022 Jun 15;163:111799. doi: 10.1016/j.exger.2022.111799. Epub 2022 Apr 4.
PubMed 35390490
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acupunch Exercises on the Frail Older Adults in Long-Term Care Facilities
- ClinicalTrials.gov ID
- NCT04481438
- Acronym / sponsor ID
- 201900696B0
- Keywords
- Acupunch exercises, Frailty, long-term care facilities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 24 Mar 2020 (actual)
- Primary completion
- 24 Mar 2021 (actual)
- Study completion
- 24 Mar 2021 (actual)
- First posted
- 22 Jul 2020 (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.
Frailty is a complex elderly problem and a precursor of functional degradation in elder adults. The aim of this study will to test the effects of acupunch exercises on the frail older adults in long-term care facilities.
Detailed description
Frailty is a complex elderly problem and a precursor of functional degradation in elder adults. The cause of frailty is multifactorial. Regular exercise intervension could improve frailty condition and general functional fitness. The acupunch exercise program was developed based on Jing-Luo theory of tranditional Chinese Medicine. The aim of this study will to test the effects of acupunch exercises on the frail older adults in long-term care facilities.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise group | Experimental | Other: Acupunch Exercisesexercise group will receive acupunch exercise |
| control group | No intervention | –control group will maintain the regular activities of their original daily lives |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- frail older adults
- aged 65 and above
- had lived in the long-term care facilities more than 3 months
Key exclusion criteria (3 listed)
- dementia patient
- psychiatric patient
- spinal cord injury patient
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 |
|---|---|---|
| Acupunch ExercisesThe acupunch exercise program was developed based on Jing-Luo theory of tranditional Chinese Medicine. The experiment group will receive Acupunch exercise for 40 minute sessions, 3 times a week, for 24 weeks | Other | exercise group |
Primary outcome
handgrip strength
Time frame: 24 weeks
handgrip strength measured by the Digital Handgrip Dynamometer (in kilograms)
upper limb muscle endurance
Time frame: 24 weeks
upper limb muscle endurance measured by the Arm Curl Test in times per 30 seconds
lower limb muscle endurance
Time frame: 24 weeks
lower limb muscle endurance measured by the Chair-to-Stand Test in times per 30 seconds
lung function
Time frame: 24 weeks
lung function measured by Peak Flow Meter (in liters)
upper body flexibility
Time frame: 24 weeks
upper body flexibility measured by the Back Scratch Test( in centimeters)
forward flexion
Time frame: 24 weeks
forward flexion measured by the Chair Sit-and-Reach Test( in centimeters)
shoulder joint flexion
Time frame: 24 weeks
shoulder joint flexion measured by protractor( in degree)
shoulder joint abduction
Time frame: 24 weeks
shoulder joint abduction measured by protractor( in degree)
1 secondary outcome
frailty status
Time frame: 24 weeks
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 8 Oct 2021.
- Results publication: PubMed 29433845Hsiao CY, Chen KM, Tsai HY, Huang HT, Cheng YY, Tsai AY. Self-Perceived Health and Sleep Quality of Community Older Adults after Acupunch Exercises. Am J Geriatr Psychiatry. 2018 May;26(5):511-520. doi: 10.1016/j.jagp.2018.01.199. Epub 2018 Jan 31.
- Results publication: PubMed 26255709Kojima G. Prevalence of Frailty in Nursing Homes: A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2015 Nov 1;16(11):940-5. doi: 10.1016/j.jamda.2015.06.025. Epub 2015 Aug 6.
- Derived from this study: PubMed 35390490Chou CP, Chen KM, Tung HT, Belcastro F, Hsu HF. Physical fitness and frailty status of frail older adults in long-term care facilities after acupunch exercises: A cluster-randomized controlled trial. Exp Gerontol. 2022 Jun 15;163:111799. doi: 10.1016/j.exger.2022.111799. Epub 2022 Apr 4.
- Individual participant dataSharing planned: No. for personal privacy reason
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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.
Chia-Pei Chou, MD study chair
Chang Gung Memorial Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupunch Exercises in people with Frailty and Exercise, run by Chang Gung Memorial Hospital at 10 sites 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 3 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 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
handgrip strength (time frame: 24 weeks). The study lists 8 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 NCT04481438, which also lists 3 linked publications.
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 8 Oct 2021.