NCT05462197

Brief Summary

Pain and sleep disturbance are common symptoms of community-dwelling older adults observed in traditional Chinese medical(TCM) clinics. Acupuncture or other medical treatments have their side effects and usage limitations, so it is expected that other non-medical interventions can relieve the symptoms. The purpose of this study was to test the effect of Qigong Wuqinxi intervention on pain, sleep quality, TCM body constitution and tongue features of the community-dwelling older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

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

Study Start

First participant enrolled

October 1, 2021

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
Last Updated

July 18, 2022

Status Verified

July 1, 2022

Enrollment Period

9 days

First QC Date

July 2, 2022

Last Update Submit

July 14, 2022

Conditions

Keywords

Qigong WuqinxiChronic PainSleep QualityTraditional Chinese Medical Body ConstitutionTongue FeaturesCommunity-Dwelling Older Adults

Outcome Measures

Primary Outcomes (3)

  • musculoskeletal chronic pain

    musculoskeletal chronic pain of the Community-Dwelling Older Adults assessed byThe Brief Pain Inventory (BPI) \[ Developed by Cleeland (1985). The pain scale has a clear human-shaped image, a total of 20 items, and the content is divided into pain intensity and pain interference subscales. The scale uses a scale of 0-10, with a pain score of 0 being no pain, 1-4 being mild pain, 5-6 being moderate pain, and 7-10 being severe pain. Good reference indicator. This scale has been widely used and translated into more than ten languages and has good reliability and validity. Ger et al. (1999) translated this scale into the Brief Pain Inventory-Taiwanese Version (BPI-T) \]

    1 month

  • health status

    health status of the Community-Dwelling Older Adults assessed by Body Constitution Questionnaire,BCQ.\[The "Traditional Chinese medicine constitution type and constitution scoring rule table" is used to analyze the patient's constitution type, and classify and classify according to the constitution scoring rules. The five-point Likert scale was used for each question, and words suitable for the frequency and intensity of the case were selected. BCQ Constitution Questionnaire: A total of 44 questions, including: 19 questions for Yin deficiency, the standard for yin deficiency constitution is more than 30 points; 19 questions for Yang deficiency, the scoring standard is more than 31 points; 16 questions for phlegm-dampness and blood stasis constitution, the judgment standard The standard is more than 27 points. If the total score does not meet the criteria for any of the three constitutions, it does not belong to any of the three constitutions, and is defined as "peaceful constitution".

    1 month

  • Tongue Features

    Tongue Features of the Community-Dwelling Older Adults assessed by Automatic Tongue Diagnosis System (ATDS) . \[ ATDS can identify nine main features, namely tongue color, tongue coating color, tongue coating thickness (ratio of thick coating), body fluid, tongue shape, cracks, vermilion spots, ecchymoses and tooth marks, to generate information about length (cm), area ( cm²), humidity and details of the number of cracks, dents, red dots. ATDS can capture tongue images and automatically and reliably extract features to assist TCM practitioners in diagnosis.

    1 month

Study Arms (2)

Qigong Wuqinxi group

EXPERIMENTAL

The Wuqinxi version adopted by this research is the Health Qigong Wuqinxi newly compiled in mainland China in 2003. There are only 10 movements in total. It is practiced three times a week for 3 months, including group practice once a week, 50 minutes each time, and the other two times of independent practice, the same 50 minutes each time, and the practice form must be filled out.

Behavioral: Qigong Wuqinxi

control group

NO INTERVENTION

The control group was carried out according to the original daily activities without any intervention activities

Interventions

Qigong WuqinxiBEHAVIORAL

Wuqinxi is an exercise method developed by the ancient Chinese physician Hua Tuo by combining the ancient guide, breathing, and imitating the shapes of five animals, such as tiger, deer, bear, ape, and bird, combined with the zang-fu and meridian theory of traditional Chinese medicine. There have been studies in the past proven that this exercise can achieve health-promoting effects

Qigong Wuqinxi group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • year olds
  • have the ability to communicate in Mandarin and Taiwanese and can answer questions orally

You may not qualify if:

  • severe mental illness,
  • moderate to severe dementia (Clinical Dementia Assessment Scale Level 2 or above)
  • almost unable to perform daily activity by self. (Barthes scale \<60)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Master Program of Long-Term Care in Aging of Kaohsiung Medical University

Kaohsiung City, 807378, Taiwan

Location

Related Publications (3)

  • Guo Y, Xu M, Wei Z, Hu Q, Chen Y, Yan J, Wei Y. Beneficial Effects of Qigong Wuqinxi in the Improvement of Health Condition, Prevention, and Treatment of Chronic Diseases: Evidence from a Systematic Review. Evid Based Complement Alternat Med. 2018 Oct 24;2018:3235950. doi: 10.1155/2018/3235950. eCollection 2018.

    PMID: 30473716BACKGROUND
  • Wei X, Xu A, Yin Y, Zhang R. The potential effect of Wuqinxi exercise for primary osteoporosis: A systematic review and meta-analysis. Maturitas. 2015 Dec;82(4):346-54. doi: 10.1016/j.maturitas.2015.08.013. Epub 2015 Sep 19.

    PMID: 26386831BACKGROUND
  • Chou TW, Kuo CC, Chen KM, Belcastro F. Influence of Qigong Wuqinxi on Pain, Sleep, and Tongue Features in Older Adults. J Nurs Res. 2024 Dec 1;32(6):e358. doi: 10.1097/jnr.0000000000000646.

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersChronic Pain

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chen k Min, Professor

    Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research project leader

Study Record Dates

First Submitted

July 2, 2022

First Posted

July 18, 2022

Study Start

October 1, 2021

Primary Completion

October 10, 2021

Study Completion

December 30, 2021

Last Updated

July 18, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations