- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04504786
Vitality Acupunch Exercise Program for Sarcopenia Older Adults (VA)
March 9, 2021 updated by: Kuei-Min Chen, Ph.D., RN., Kaohsiung Medical University
Effects of the Vitality Acupunch Exercise Program on the ADL and Functional Fitness of Sarcopenia Older Adults
This project was aimed to test the effects of a six-month VA program on the activities of daily living (ADL) and functional fitness of institutional older adults with sarcopenia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A cluster-randomized controlled trial was conducted to test the effects of a six-month VA program on ADL and functional fitness (lung capacity, body flexibility, range of the joint's motion, and muscle endurance) 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 six months; the control group continued with their regular daily activities.
One pre-test and two post-tests, three months apart, were conducted.
Study Type
Interventional
Enrollment (Actual)
114
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kaohsiung, Taiwan, 80708
- Kaohsiung Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 100 years (OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age ≥ 65 years old
- have been living in the facility for at least three months
- intact cognitive function with the Short Portable Mental Status Questionnaire (SPMSQ) 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
Exclusion Criteria:
- have spinal cord injury
- have severe cardiovascular or pulmonary diseases
- have musculoskeletal diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Control
Participants in the control group continued with their daily activities as usual.
|
Participants maintained their daily activities.
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EXPERIMENTAL: Vitality acupunch (VA)
The VA program took 40 minutes to complete and included three 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 and certified by the PI, 3 times per week and 40 minutes per session for 6 months.
|
The VA had three phases and took 40 minutes to complete.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung capacity
Time Frame: 6 months
|
measured by the TruZoneTM Peak Flow Meter
|
6 months
|
Upper body flexibility
Time Frame: 6 months
|
measured by the Back Scratch Test
|
6 months
|
Lower body flexibility
Time Frame: 6 months
|
measured by the Chair Sit-and-Reach Test
|
6 months
|
Range of joint motion
Time Frame: 6 months
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measured by the goniometry
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6 months
|
Arm muscle endurance
Time Frame: 6 months
|
measured by the Arm Curl Test
|
6 months
|
Leg muscle endurance
Time Frame: 6 months
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measured by the Chair-to-Stand Test
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6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Activities of daily living (ADL)
Time Frame: 6 months
|
measured by the Barthel Index.
The score of "0-20" means totally dependent; "21-60" means heavily dependent; "61-90" means moderately dependent; "91-99" means mildly dependent; "100" indicates total independence in the ADL of a person.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 7, 2020
Primary Completion (ACTUAL)
March 6, 2021
Study Completion (ACTUAL)
March 6, 2021
Study Registration Dates
First Submitted
August 5, 2020
First Submitted That Met QC Criteria
August 5, 2020
First Posted (ACTUAL)
August 7, 2020
Study Record Updates
Last Update Posted (ACTUAL)
March 11, 2021
Last Update Submitted That Met QC Criteria
March 9, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMUHIRB-F(II)-20190045(1)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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