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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04504786
Other study ID # KMUHIRB-F(II)-20190045(1)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 7, 2020
Est. completion date March 6, 2021

Study information

Verified date March 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 activities of daily living (ADL) and functional fitness 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 114
Est. completion date March 6, 2021
Est. primary completion date March 6, 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 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Vitality acupunch (VA) exercise program
The VA had three 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 Lung capacity measured by the TruZoneTM Peak Flow Meter 6 months
Primary Upper body flexibility measured by the Back Scratch Test 6 months
Primary Lower body flexibility measured by the Chair Sit-and-Reach Test 6 months
Primary Range of joint motion measured by the goniometry 6 months
Primary Arm muscle endurance measured by the Arm Curl Test 6 months
Primary Leg muscle endurance measured by the Chair-to-Stand Test 6 months
Secondary Activities of daily living (ADL) 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
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