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The Influence of Qigong Wuqinxi on Health Status of the Community-Dwelling Older Adults

Primary Purpose

Sleep Quality, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Qigong Wuqinxi
Sponsored by
Kaohsiung Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Quality focused on measuring Qigong Wuqinxi, Chronic Pain, Sleep Quality, Traditional Chinese Medical Body Constitution, Tongue Features, Community-Dwelling Older Adults

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Qigong Wuqinxi group

control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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) ]
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".
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.

Secondary Outcome Measures

Full Information

First Posted
July 2, 2022
Last Updated
July 14, 2022
Sponsor
Kaohsiung Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05462197
Brief Title
The Influence of Qigong Wuqinxi on Health Status of the Community-Dwelling Older Adults
Official Title
The Influence of Qigong Wuqinxi on Chronic Pain, Sleep Quality, Traditional Chinese Medical Body Constitution, and Tongue Features of the Community-Dwelling Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 10, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Quality, Chronic Pain
Keywords
Qigong Wuqinxi, Chronic Pain, Sleep Quality, Traditional Chinese Medical Body Constitution, Tongue Features, Community-Dwelling Older Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Qigong Wuqinxi group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
The control group was carried out according to the original daily activities without any intervention activities
Intervention Type
Behavioral
Intervention Name(s)
Qigong Wuqinxi
Intervention Description
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
Primary Outcome Measure Information:
Title
musculoskeletal chronic pain
Description
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) ]
Time Frame
1 month
Title
health status
Description
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".
Time Frame
1 month
Title
Tongue Features
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen k Min, Professor
Organizational Affiliation
Kaohsiung Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Master Program of Long-Term Care in Aging of Kaohsiung Medical University
City
Kaohsiung
ZIP/Postal Code
807378
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30473716
Citation
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.
Results Reference
background
PubMed Identifier
26386831
Citation
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.
Results Reference
background

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The Influence of Qigong Wuqinxi on Health Status of the Community-Dwelling Older Adults

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