Sleep QualityNCT06532864
Qigong Exercise and Sleep Quality
A study testing Practice Mawangdui Guiding Technique in people with Sleep Quality, run by Hunan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sleep Quality
- What is being tested?
- Practice Mawangdui Guiding Technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 20 Aug 2024
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sleep Quality
- Being tested
- Practice Mawangdui Guiding Technique
- Keywords
- sleep quality, older adults
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice Mawangdui Guiding TechniqueBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Practicing Mawangdui Guidance Exersize Group | Experimental | The experimental group underwent the Mawangdui Guided Exercise, which consisted of five 45-minute sessions per week for 12 weeks. Receives: Behavioral: Practice Mawangdui Guiding Technique |
| Sleep Education Group | No intervention | The control group maintained routine sleep education in addition to daily activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index
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.
Measured: baseline; 4 weeks; 12weeks
Insomnia Severity Index
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.
Measured: baseline; 4 weeks; 12weeks
Polysomnography
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.
Measured: baseline; 4 weeks; 12weeks
Flinders Fatigue Scale
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.
Measured: baseline; 4 weeks; 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Jun 2024
- Primary completion15 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Participants were randomly assigned to experimental and control groups. The experimental group performed Mawangdui Guided Technique exercises, which consisted of five 45-minute sessions per week for 12 weeks. The control group maintained a routine of sleep education in addition to their daily activities.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huan Liu, Hunan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532864
- Sponsor's protocol ID
- 2022XH0111
- Status last verified
- Jul 2024
- First submitted
- 29 Jul 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Qigong Exercise and Mawangdui Guiding Technique on Sleep Quality in the Elderly
- ClinicalTrials.gov ID
- NCT06532864
- Acronym / sponsor ID
- 2022XH0111
- Conditions
- Sleep Quality
- Keywords
- sleep quality, older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hunan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to experimental and control groups. The experimental group performed Mawangdui Guided Technique exercises, which consisted of five 45-minute sessions per week for 12 weeks. The control group maintained a routine of sleep education in addition to their daily activities.
| Arm | Type | Receives |
|---|---|---|
| Practicing Mawangdui Guidance Exersize Group | Experimental | Behavioral: Practice Mawangdui Guiding TechniqueThe experimental group underwent the Mawangdui Guided Exercise, which consisted of five 45-minute sessions per week for 12 weeks. |
| Sleep Education Group | No intervention | –The control group maintained routine sleep education in addition to daily activities. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Practice Mawangdui Guiding TechniqueNursing 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. | Behavioural | Practicing Mawangdui Guidance Exersize Group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Practice Mawangdui Guiding Technique in people with Sleep Quality, run by Hunan University of Traditional Chinese Medicine at 1 site in China.
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 3 inclusion and 5 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 1 Oct 2024. 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 China. 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?
Pittsburgh Sleep Quality Index (time frame: baseline; 4 weeks; 12weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2024.