NCT04504786

Brief 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.

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 Aug 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

August 7, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2021

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

August 5, 2020

Last Update Submit

March 9, 2021

Conditions

Outcome Measures

Primary Outcomes (6)

  • Lung capacity

    measured by the TruZoneTM Peak Flow Meter

    6 months

  • Upper body flexibility

    measured by the Back Scratch Test

    6 months

  • Lower body flexibility

    measured by the Chair Sit-and-Reach Test

    6 months

  • Range of joint motion

    measured by the goniometry

    6 months

  • Arm muscle endurance

    measured by the Arm Curl Test

    6 months

  • Leg muscle endurance

    measured by the Chair-to-Stand Test

    6 months

Secondary Outcomes (1)

  • Activities of daily living (ADL)

    6 months

Study Arms (2)

Vitality acupunch (VA)

EXPERIMENTAL

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.

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 three 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 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

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, Huang KC, Hsu HF, Chou CP, Kuo CF. Effects of Vitality Acupunch exercise on functional fitness and activities of daily living among probable sarcopenic older adults in residential facilities. J Nurs Scholarsh. 2022 Mar;54(2):176-183. doi: 10.1111/jnu.12723. Epub 2021 Nov 8.

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 5, 2020

First Posted

August 7, 2020

Study Start

August 7, 2020

Primary Completion

March 6, 2021

Study Completion

March 6, 2021

Last Updated

March 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations