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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04535336
Other study ID # KMUHIRB-F(II)-20190045(2)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2, 2020
Est. completion date April 9, 2021

Study information

Verified date April 2021
Source Kaohsiung Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 114
Est. completion date April 9, 2021
Est. primary completion date April 9, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Vitality acupunch (VA) exercise program
The VA had 3 phases and took 40 minutes to complete.
Control
Participants maintained their daily activities.

Locations

Country Name City State
Taiwan Kaohsiung Medical University Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Kaohsiung Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle mass measured by the calf circumference 6 months
Primary Muscle strength measured by the Digital Handgrip Dynamometer (TKK-5101) 6 months
Secondary Sleep quality Measured by the Pittsburgh Sleep Quality Index (PSQI): score ranges from 0-21; > 5 indicates clinically significant sleep disruptions. 6 months
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