NCT04535336

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

September 2, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2021

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

7 months

First QC Date

August 31, 2020

Last Update Submit

April 10, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Muscle mass

    measured by the calf circumference

    6 months

  • Muscle strength

    measured by the Digital Handgrip Dynamometer (TKK-5101)

    6 months

Secondary Outcomes (1)

  • Sleep quality

    6 months

Study Arms (2)

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.

Other: Vitality acupunch (VA) exercise program

Control

ACTIVE COMPARATOR

Participants in the control group continued with their daily activities as usual.

Other: Control

Interventions

The VA had 3 phases and took 40 minutes to complete.

Vitality acupunch (VA)
ControlOTHER

Participants maintained their daily activities.

Control

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • have spinal cord injury
  • have severe cardiovascular or pulmonary diseases
  • have musculoskeletal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, 80708, Taiwan

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Kuei-Min Chen, PhD

    Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 1, 2020

Study Start

September 2, 2020

Primary Completion

April 9, 2021

Study Completion

April 9, 2021

Last Updated

April 14, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations