- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05462197
The Influence of Qigong Wuqinxi on Health Status of the Community-Dwelling Older Adults
July 14, 2022 updated by: Tzu-wei Chou, Kaohsiung Medical University
The Influence of Qigong Wuqinxi on Chronic Pain, Sleep Quality, Traditional Chinese Medical Body Constitution, and Tongue Features of the Community-Dwelling Older Adults
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Methods: using cluster randomised clinical trial , two community care sites in Sanmin District, Kaohsiung City were selected.
Community-dwelling older adults who are over 65 years old and have the ability to communicate in Mandarin and Taiwanese were recruited .
Those who had severe mental illness, moderate to severe dementia (level 2 or above on the Clinical Dementia Assessment Scale) and Barthel Index score <60 were excluded.
There were 63 valid cases divided into experimental group(n=32) and control group(n=31).
The experimental group practiced Qigong Wuqinxi 50 minutes three times a week for 12 weeks; meanwhile, the control group maintained routine daily activities.
The two groups of participants were tested before and after the intervention period with the following research tools: 1) The Brief Pain Inventory, (BPI), 2) Pittsburgh Sleep Quality Index (PSQI), 3) Body Constitution Questionnaire (BCQ), 4) automatic tongue diagnosis system (ATDS).
The research data were analyzed with SPSS 19 software package for descriptive statistics, chi-square test, independent t test and paired t test.
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kaohsiung, Taiwan, 807378
- Master Program of Long-Term Care in Aging of Kaohsiung Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 85 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 65-85 year olds
- have the ability to communicate in Mandarin and Taiwanese and can answer questions orally
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Qigong Wuqinxi group
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.
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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
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No Intervention: control group
The control group was carried out according to the original daily activities without any intervention activities
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
musculoskeletal chronic pain
Time Frame: 1 month
|
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) ]
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1 month
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health status
Time Frame: 1 month
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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".
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1 month
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Tongue Features
Time Frame: 1 month
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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.
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1 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chen k Min, Professor, Kaohsiung Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2021
Primary Completion (Actual)
October 10, 2021
Study Completion (Actual)
December 30, 2021
Study Registration Dates
First Submitted
July 2, 2022
First Submitted That Met QC Criteria
July 14, 2022
First Posted (Actual)
July 18, 2022
Study Record Updates
Last Update Posted (Actual)
July 18, 2022
Last Update Submitted That Met QC Criteria
July 14, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-049-B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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