- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06532864
Qigong Exercise and Sleep Quality
September 28, 2024 updated by: Huan Liu, Hunan University of Traditional Chinese Medicine
Effects of Qigong Exercise and Mawangdui Guiding Technique on Sleep Quality in the Elderly
The purpose of this study was to investigate whether 12 weeks of practicing Mawangdui Guiding Technique has an improvement effect on subjective sleep quality, objective sleep quality, and daytime fatigue in older adults in a healthcare hospital.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
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
-
-
Hunan
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Changsha, Hunan, China, 410000
- Healthcare Hospital
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Aged sixty years and above; continuous residence in the participating healthcare hospitals for more than six months
- Conscious, with basic visual and auditory perception, communication, and cognitive functioning
- Voluntary enrollment in this study and signing of the informed consent form.
Exclusion Criteria:
- Individuals who have suffered a sudden accident, emergency surgery, or a rapid deterioration of a long-term medical condition
- Individuals who have recently been involved in other rehabilitation activities and who play sports on a regular basis
- Individuals who are unable to participate in physical activity (e.g., patients suffering from major diseases of the liver, kidneys, heart, brain, or blood system)
- Individuals suffering from deep venous thrombosis; individuals with musculoskeletal problems with signs of limitation of movement (e.g., unsettled broken bones, pelvic fractures)
- Individuals with preexisting psychiatric conditions (such as personality disorders, psychosis, and so on); and individuals with symptoms of severe depression.
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Practicing Mawangdui Guidance Exersize Group
The experimental group underwent the Mawangdui Guided Exercise, which consisted of five 45-minute sessions per week for 12 weeks.
|
Nursing staff with experience in teaching Mawangdui Daoyin Exercise conducted the operation instruction on different floors.
A feasibility assessment of the older adults was carried out by the nursing staff at the end of the teaching, and only after passing this assessment could the experimental part begin.
The treatment group participated in five Mawangdui Daoyin Exercise sessions per week, each lasting approximately 45 minutes, and the exercises continued for 12 weeks.
|
|
No Intervention: Sleep Education Group
The control group maintained routine sleep education in addition to daily activities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pittsburgh Sleep Quality Index
Time Frame: baseline; 4 weeks; 12weeks
|
The Pittsburgh Sleep Quality Index is a comprehensive sleep self-assessment tool containing 19 items.
The overall total score ranges from 0-21, with the lower the overall score, the higher the quality of sleep.
|
baseline; 4 weeks; 12weeks
|
|
Insomnia Severity Index
Time Frame: baseline; 4 weeks; 12weeks
|
The Insomnia Severity Index(ISI) is a self-assessment tool consisting of seven items designed to assess various aspects of insomnia.
Cumulative ISI scores range from 0 to 28 and are categorized as follows: 0-7 = no insomnia; 8-14 = mild insomnia; 15-21 = moderate insomnia; and 22-28 = severe insomnia.
|
baseline; 4 weeks; 12weeks
|
|
Polysomnography
Time Frame: baseline; 4 weeks; 12weeks
|
Polysomnography is the internationally recognized gold standard for diagnosing sleep disorder disorders and can provide an objective basis for the diagnosis, classification and identification of sleep disorders.
|
baseline; 4 weeks; 12weeks
|
|
Flinders Fatigue Scale
Time Frame: baseline; 4 weeks; 12weeks
|
The Flinders Fatigue Scale is a 7-item scale that measures various characteristics of fatigue.
Total fatigue scores range from 0 to 31, with higher scores indicating more severe fatigue.
|
baseline; 4 weeks; 12weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
June 1, 2024
Primary Completion (Actual)
August 15, 2024
Study Completion (Actual)
August 20, 2024
Study Registration Dates
First Submitted
July 29, 2024
First Submitted That Met QC Criteria
July 29, 2024
First Posted (Actual)
August 1, 2024
Study Record Updates
Last Update Posted (Actual)
October 1, 2024
Last Update Submitted That Met QC Criteria
September 28, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2022XH0111
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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