AzTrials
AzTrials

Sleep QualityNCT05462197

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

A study testing Qigong Wuqinxi in people with Sleep Quality and Chronic Pain, run by Kaohsiung Medical University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 65 to 85 years
Conditions the study is for
Sleep Quality, Chronic Pain
What is being tested?
Qigong Wuqinxi
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteTaiwan
Study dates
1 Oct 2021to 30 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 85 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 65-85 year olds
  • have the ability to communicate in Mandarin and Taiwanese and can answer questions orally

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

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

    Kaohsiung City, 807378

Other trials in Taiwan

About this study

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

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.

Read the 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.

Being tested
Qigong Wuqinxi
Keywords
Qigong Wuqinxi, Chronic Pain, Sleep Quality, Traditional Chinese Medical Body Constitution, Tongue Features, Community-Dwelling Older Adults
Medical subject headings
Sleep Initiation and Maintenance Disorders, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Qigong WuqinxiBehavioural

    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

Study groups in NCT05462197
Study groupRoleWhat they receive
Qigong Wuqinxi groupExperimentalThe 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.
Receives: Behavioral: Qigong Wuqinxi
control groupNo interventionThe control group was carried out according to the original daily activities without any intervention activities

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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) ]

    Measured: 1 month

  2. 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".

    Measured: 1 month

  3. 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.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2022
  2. Study start1 Oct 2021
  3. Primary completion10 Oct 2021
  4. Study completion30 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05462197
Sponsor's protocol ID
21-049-B
Status last verified
Jul 2022
First submitted
2 Jul 2022
Last updated
18 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 30473716

  • 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.

    PubMed 26386831

  • 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.

    PubMed 39593225

Questions about this trial

What is this clinical trial studying?

A study testing Qigong Wuqinxi in people with Sleep Quality and Chronic Pain, run by Kaohsiung Medical University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

musculoskeletal chronic pain (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05462197, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in