- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04535336
Vitality Acupunch Exercise Program for Older Adults With Sarcopenia (VA)
April 10, 2021 updated by: Kuei-Min Chen, Ph.D., RN., Kaohsiung Medical University
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.
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 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 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 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
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 |
---|---|
EXPERIMENTAL: Vitality acupunch (VA)
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.
|
The VA had 3 phases and took 40 minutes to complete.
|
ACTIVE_COMPARATOR: Control
Participants in the control group continued with their daily activities as usual.
|
Participants maintained their daily activities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle mass
Time Frame: 6 months
|
measured by the calf circumference
|
6 months
|
Muscle strength
Time Frame: 6 months
|
measured by the Digital Handgrip Dynamometer (TKK-5101)
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep quality
Time Frame: 6 months
|
Measured by the Pittsburgh Sleep Quality Index (PSQI): score ranges from 0-21; > 5 indicates clinically significant sleep disruptions.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
September 2, 2020
Primary Completion (ACTUAL)
April 9, 2021
Study Completion (ACTUAL)
April 9, 2021
Study Registration Dates
First Submitted
August 31, 2020
First Submitted That Met QC Criteria
August 31, 2020
First Posted (ACTUAL)
September 1, 2020
Study Record Updates
Last Update Posted (ACTUAL)
April 14, 2021
Last Update Submitted That Met QC Criteria
April 10, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMUHIRB-F(II)-20190045(2)
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.
Clinical Trials on Sleep Quality
-
PrecisionBiotics Group Ltd.Nottingham Trent University; Atlantia Food Clinical Trials Ltd.CompletedSubjective Sleep Quality | Objective Sleep QualityIreland
-
Brain Electrophysiology Laboratory CompanyRecruiting
-
University GhentEuropean CommissionEnrolling by invitation
-
Northumbria UniversityCompletedSleep | Mood | Poor Quality Sleep | Good Sleep HabitUnited Kingdom
-
West Virginia UniversityCompletedSleep QualityUnited States
-
Icahn School of Medicine at Mount SinaiNot yet recruiting
-
West Virginia UniversityActive, not recruiting
-
West Virginia UniversityCompletedSleep QualityUnited States
-
Sakarya UniversityEnrolling by invitation
-
Maharishi Markendeswar University (Deemed to be...Completed
Clinical Trials on Vitality acupunch (VA) exercise program
-
Kaohsiung Medical UniversityCompletedActivities of Daily Living | Functional FitnessTaiwan
-
VA Office of Research and DevelopmentRecruitingAnger | PTSD | TBI | Veterans | Suicide Prevention | TransdiagnosticUnited States
-
Azienda Sanitaria Locale CN1 CuneoNot yet recruiting
-
University of MiamiRecruiting
-
Riphah International UniversityCompletedSports Physical Therapy | Sports InjuryPakistan
-
Marmara UniversityCompletedCervical Disc HerniationTurkey
-
Marius HenriksenCompletedPatellofemoral Pain SyndromeDenmark
-
University of ÉvoraSão João de Deus School of Nursing; Horizon 2020 - Portugal 2020 (ALT20-03-0145-FEDER-000007...CompletedFallers | High Risk of FallingPortugal
-
Loma Linda UniversityCompletedBalance ChangesUnited States
-
State University of New York - Upstate Medical...CompletedMuscle Weakness