Muscle MassVANCT04535336
Vitality Acupunch Exercise Program for Older Adults With Sarcopenia
A study testing Vitality acupunch (VA) exercise program in people with Muscle Mass and Muscle Strength, run by Kaohsiung Medical University at 1 site in Taiwan.
Trial summary
This project was aimed to test the effects of a six-month VA program on the muscle mass, muscle strength, and quality of sleep of institutional older adults with sarcopenia. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Mass, Muscle Strength, Sleep Quality
- What is being tested?
- Vitality acupunch (VA) exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Sep 2020to 9 Apr 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 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age ≥ 65 years old
- have been living in the facility for at least 3 months
- intact cognitive function with the Short Portable Mental Status Questionnaire score ≥ 8
- hand-grip strength < 28 kg for men and < 18 kg for women
- calf circumference < 34 cm for men and < 33 cm for women
Who cannot join
- have spinal cord injury
- have severe cardiovascular or pulmonary diseases
- have musculoskeletal diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Vitality Acupunch Exercise Program on the Muscle Mass, Muscle Strength, and Sleep Quality of Older Adults With Sarcopenia
This project was aimed to test the effects of a six-month VA program on the muscle mass, muscle strength, and quality of sleep of institutional older adults with sarcopenia.
Read the detailed description
A cluster-randomized controlled trial was conducted to test the effects of a six-month VA program on the muscle mass, muscle strength, and quality of sleep of institutional older adults with sarcopenia. Using convenience sampling, 12 long-term care facilities with 114 older adults were recruited, and then cluster-randomized by the facility to a VA experimental or a control group. The experimental group received the VA program led by certified instructors 3 times per week and 40 minutes per session for 6 months; the control group continued with their regular daily activities. One pre-test and two post-tests, 3 months apart, were conducted.
- Conditions
- Muscle Mass, Muscle Strength, Sleep Quality
- Being tested
- Vitality acupunch (VA) exercise program, Control
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitality acupunch (VA) exercise programOther
The VA had 3 phases and took 40 minutes to complete.
ControlOther
Participants maintained their daily activities.
| Study group | Role | What they receive |
|---|---|---|
| Vitality acupunch (VA) | Experimental | The VA program took 40 minutes to complete and included 3 phases: 1) activating qi and blood (5 movements, 10 minutes): warm-up exercises that allowed the body to accumulate heat and promote flexibility of the joints to loosen up the body, 2) punching meridians (14 movements, 20 minutes): both hands were used to exert a vibrating effect according to the rhythms that stimulate the 14 meridians in the entire body to improve aerobic endurance, and 3) relaxing body and mind (5 movements, 10 minutes): muscle relaxing exercises to rest the body and cease the qi. Participants in the experimental group received the VA program led by the instructors, who were trained an certified by the PI, 3 times per week and 40 minutes per session for 6 months. Receives: Other: Vitality acupunch (VA) exercise program |
| Control | Active comparator | Participants in the control group continued with their daily activities as usual. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
measured by the calf circumference
Measured: 6 months
Muscle strength
measured by the Digital Handgrip Dynamometer (TKK-5101)
Measured: 6 months
Secondary outcomes (1)
Sleep quality
Measured by the Pittsburgh Sleep Quality Index (PSQI): score ranges from 0-21; > 5 indicates clinically significant sleep disruptions.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start2 Sep 2020
- Primary completion9 Apr 2021
- Study completion9 Apr 2021
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 Muscle MassStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuei-Min Chen, Ph.D., RN., Kaohsiung Medical University
- Investigators
- Kuei-Min Chen, PhD, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535336
- Sponsor's protocol ID
- KMUHIRB-F(II)-20190045(2)
- Acronym
- VA
- Status last verified
- Apr 2021
- First submitted
- 31 Aug 2020
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tung HT, Chen KM, Chou CP, Belcastro F, Hsu HF, Kuo CF. Acupunch Exercise Improved Muscle Mass, Hand Grip Strength, and Sleep Quality of Institutional Older Adults with Probable Sarcopenia. J Appl Gerontol. 2023 May;42(5):888-897. doi: 10.1177/07334648221141413. Epub 2022 Nov 30.
PubMed 36448359
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Vitality Acupunch Exercise Program on the Muscle Mass, Muscle Strength, and Sleep Quality of Older Adults With Sarcopenia
- ClinicalTrials.gov ID
- NCT04535336
- Acronym / sponsor ID
- VA / KMUHIRB-F(II)-20190045(2)
- Conditions
- Muscle Mass, Muscle Strength, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 9 Apr 2021 (actual)
- First posted
- 1 Sep 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.
This project was aimed to test the effects of a six-month VA program on the muscle mass, muscle strength, and quality of sleep of institutional older adults with sarcopenia.
Detailed description
A cluster-randomized controlled trial was conducted to test the effects of a six-month VA program on the muscle mass, muscle strength, and quality of sleep of institutional older adults with sarcopenia. Using convenience sampling, 12 long-term care facilities with 114 older adults were recruited, and then cluster-randomized by the facility to a VA experimental or a control group. The experimental group received the VA program led by certified instructors 3 times per week and 40 minutes per session for 6 months; the control group continued with their regular daily activities. One pre-test and two post-tests, 3 months apart, were conducted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitality acupunch (VA) | Experimental | Other: Vitality acupunch (VA) exercise programThe VA program took 40 minutes to complete and included 3 phases: 1) activating qi and blood (5 movements, 10 minutes): warm-up exercises that allowed the body to accumulate heat and promote flexibility of the joints to loosen up the body, 2) punching meridians (14 movements, 20 minutes): both hands were used to exert a vibrating effect according to the rhythms that stimulate the 14 meridians in the entire body to improve aerobic endurance, and 3) relaxing body and mind (5 movements, 10 minutes): muscle relaxing exercises to rest the body and cease the qi. Participants in the experimental group received the VA program led by the instructors, who were trained an certified by the PI, 3 times per week and 40 minutes per session for 6 months. |
| Control | Active comparator | Other: ControlParticipants in the control group continued with their daily activities as usual. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- age ≥ 65 years old
- have been living in the facility for at least 3 months
- intact cognitive function with the Short Portable Mental Status Questionnaire score ≥ 8
- hand-grip strength < 28 kg for men and < 18 kg for women
- calf circumference < 34 cm for men and < 33 cm for women
Key exclusion criteria (3 listed)
- have spinal cord injury
- have severe cardiovascular or pulmonary diseases
- have musculoskeletal diseases
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 |
|---|---|---|
| Vitality acupunch (VA) exercise programThe VA had 3 phases and took 40 minutes to complete. | Other | Vitality acupunch (VA) |
| ControlParticipants maintained their daily activities. | Other | Control |
Primary outcome
Muscle mass
Time frame: 6 months
measured by the calf circumference
Muscle strength
Time frame: 6 months
measured by the Digital Handgrip Dynamometer (TKK-5101)
1 secondary outcome
Sleep quality
Time frame: 6 months
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 14 Apr 2021.
- Derived from this study: PubMed 36448359Tung HT, Chen KM, Chou CP, Belcastro F, Hsu HF, Kuo CF. Acupunch Exercise Improved Muscle Mass, Hand Grip Strength, and Sleep Quality of Institutional Older Adults with Probable Sarcopenia. J Appl Gerontol. 2023 May;42(5):888-897. doi: 10.1177/07334648221141413. Epub 2022 Nov 30.
- 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.
Kuei-Min Chen, PhD principal investigator
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitality acupunch (VA) exercise program in people with Muscle Mass and Muscle Strength, run by Kaohsiung Medical University 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 5 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 14 Apr 2021. 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?
Muscle mass (time frame: 6 months). The study lists 2 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 NCT04535336, 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 14 Apr 2021; AzTrials last refreshed its copy on 30 Oct 2026.