NCT04481438

Brief Summary

Frailty is a complex elderly problem and a precursor of functional degradation in elder adults. The aim of this study will to test the effects of acupunch exercises on the frail older adults in long-term care facilities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

10 active sites

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

Study Start

First participant enrolled

March 24, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2021

Completed
Last Updated

October 8, 2021

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

July 14, 2020

Last Update Submit

September 30, 2021

Conditions

FrailtyExercise

Keywords

Acupunch exercisesFrailtylong-term care facilities

Outcome Measures

Primary Outcomes (8)

  • handgrip strength

    handgrip strength measured by the Digital Handgrip Dynamometer (in kilograms)

    24 weeks

  • upper limb muscle endurance

    upper limb muscle endurance measured by the Arm Curl Test in times per 30 seconds

    24 weeks

  • lower limb muscle endurance

    lower limb muscle endurance measured by the Chair-to-Stand Test in times per 30 seconds

    24 weeks

  • lung function

    lung function measured by Peak Flow Meter (in liters)

    24 weeks

  • upper body flexibility

    upper body flexibility measured by the Back Scratch Test( in centimeters)

    24 weeks

  • forward flexion

    forward flexion measured by the Chair Sit-and-Reach Test( in centimeters)

    24 weeks

  • shoulder joint flexion

    shoulder joint flexion measured by protractor( in degree)

    24 weeks

  • shoulder joint abduction

    shoulder joint abduction measured by protractor( in degree)

    24 weeks

Secondary Outcomes (1)

  • frailty status

    24 weeks

Study Arms (2)

exercise group

EXPERIMENTAL

exercise group will receive acupunch exercise

Other: Acupunch Exercises

control group

NO INTERVENTION

control group will maintain the regular activities of their original daily lives

Interventions

Acupunch ExercisesOTHER

The acupunch exercise program was developed based on Jing-Luo theory of tranditional Chinese Medicine. The experiment group will receive Acupunch exercise for 40 minute sessions, 3 times a week, for 24 weeks

exercise group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • frail older adults
  • aged 65 and above
  • had lived in the long-term care facilities more than 3 months

You may not qualify if:

  • dementia patient
  • psychiatric patient
  • spinal cord injury patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Conservation Center

Daliao, Kaohsiung, 831, Taiwan

Location

Elderly Care Center

Fongshan District, Kaohsiung, 830, Taiwan

Location

Nursing Home

Gangshan, Kaohsiung, 820, Taiwan

Location

Nursing Home

Sanmin, Kaohsiung, 807, Taiwan

Location

Elderly Care Center

Renwu, Kaohsiung City, 833, Taiwan

Location

Citizens' Home

Yanchao, Kaohsiung City, 824, Taiwan

Location

Nursing Home

Pingtung City, Pingtung City, 900, Taiwan

Location

Nursing Home

Chaozhou, Pingtung, 920, Taiwan

Location

Nursing Home

Pingtung City, 900, Taiwan

Location

Senior Citizens' Home

Pingtung City, 900, Taiwan

Location

Related Publications (3)

  • Hsiao CY, Chen KM, Tsai HY, Huang HT, Cheng YY, Tsai AY. Self-Perceived Health and Sleep Quality of Community Older Adults after Acupunch Exercises. Am J Geriatr Psychiatry. 2018 May;26(5):511-520. doi: 10.1016/j.jagp.2018.01.199. Epub 2018 Jan 31.

    PMID: 29433845RESULT

  • Kojima G. Prevalence of Frailty in Nursing Homes: A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2015 Nov 1;16(11):940-5. doi: 10.1016/j.jamda.2015.06.025. Epub 2015 Aug 6.

    PMID: 26255709RESULT

  • Chou CP, Chen KM, Tung HT, Belcastro F, Hsu HF. Physical fitness and frailty status of frail older adults in long-term care facilities after acupunch exercises: A cluster-randomized controlled trial. Exp Gerontol. 2022 Jun 15;163:111799. doi: 10.1016/j.exger.2022.111799. Epub 2022 Apr 4.

    PMID: 35390490DERIVED

MeSH Terms

Conditions

FrailtyMotor Activity

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Chia-Pei Chou, MD

    Chang Gung Memorial Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor, Family Medicine Department

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 22, 2020

Study Start

March 24, 2020

Primary Completion

March 24, 2021

Study Completion

March 24, 2021

Last Updated

October 8, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

for personal privacy reason

Locations

TW(10)