InsomniaNCT02260843
Efficacy of Tai Chi Training on Insomnia in Older Adults
A study testing Generic Fitness and Tai Chi Intervention in people with Insomnia and Poor Sleeping Quality, run by Angus Yu at 3 sites in China.
Trial summary
Elderly insomnia is a serious public health problem. Current conventional approaches for treating insomnia are not suitable or effective in elderly population. It has been previously demonstrated that Tai Chi has definite advantages to be developed as self-help therapy in older adults and has been preliminarily… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Insomnia, Poor Sleeping Quality
- What is being tested?
- Generic Fitness and Tai Chi Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 3 sitesChina
- Study dates
- Aug 2014to Aug 2018
- 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
- 60 years or older
- ethnic Chinese
- fulfill the DSM-V criteria for chronic insomnia including difficulties to initiate sleep, maintain sleep or non-restorative sleep with complaint of impairment of daytime functioning, sleep difficulty occurs at least 3 nights per week and is present for at least three months.
Who cannot join
- cannot walk without assistive tool (e.g., cane)
- any serious somatic condition that prevent participation for Tai Chi/generic fitness activities
- current regular practicing of moderate exercise training or Tai Chi (>3 times a week of >30-min per session)
- any serious chronic diseases known to affect sleep (e.g., cancer and autoimmune diseases)
- under treatment of serious diseases known to affect sleep (e.g., cancer chemotherapy)
- any chronic pain disorders known to affect sleep.
Trial locations and contacts
3 sites in 1 country.
China3 sites
The Chinese University of Hong Kong
Hong Kong, Hong Kong, 852
The University of Hong Kong
Hong Kong, Hong Kong, 852
The Hong Kong Polytechnic University
Hong Kong, 852
About this study
Official title: Efficacy of Tai Chi Training to Alleviate Insomnia in Older Adults: A Randomized Controlled Trial
Elderly insomnia is a serious public health problem. Current conventional approaches for treating insomnia are not suitable or effective in elderly population. It has been previously demonstrated that Tai Chi has definite advantages to be developed as self-help therapy in older adults and has been preliminarily demonstrated to improve sleep in older people. This project aims to evaluate the efficacy of Tai Chi training on alleviating chronic insomnia in older adults.
Read the detailed description
Elderly insomnia is a serious public health problem. It has been estimated over 50% of elderly have sustained sleep complaints. About 20-40% of the elderly worldwide are reported insomniac. In Hong Kong, a high proportion (38%) of older people have been reported to have sleep disorders. These figures are alarming because insomnia associates with co-morbidities including cognitive impairment, depression, mood/anxiety disorders, risks for falls, hypertension, and heart disease in elderly. It also destructively affects daily functioning by impairing the memory and reducing the attention span and response time. Most importantly, insomnia has been evidently shown to link with the increased risk of hospitalization and mortality. As the proportion of geriatric population is rapidly increasing, it is foreseeable that the socioeconomic impact of elderly insomnia to the healthcare system will be undoubtedly aggravated.
Current conventional approaches for treating insomnia are not suitable or effective in elderly population. Pharmacologic treatment has always been a concern in insomniac senior patients due to the adverse drug effects including dependence, abuse, cognitive impairment and increase in risk of falls and hip fractures. With fewer adverse effects and consistent efficacy, cognitive behavioral therapy (CBT) is taken as a more appropriate remedy for elderly insomnia. However, the operation of effective CBT for insomnia is very labor demanding and cost-ineffective. The large-scale use of CBT for elderly insomnia is not feasible due to the shortage of CBT specialty-trained healthcare providers and the high treatment cost. The limited availability of CBT treatment is far insufficient to match with the increasingly large demand of insomniac elderly. There is another problem with the conventional approaches. It is observed that most of the insomnia sufferers would not seek timely clinical consultation and they tend to initiate self-help treatments when facing the problem of insomnia. This situation is suggested to be more common in Chinese elderly due to the traditional Confucius philosophy of reservation and quietness probably drive them more likely to keep the problem to themselves and become reluctant to seek prompt clinical help until serious medical symptom occurs. Given the prevalence of elderly insomnia is already high and keeps increasing, there is an urgent need to explore other effective therapeutic modalities preferably in forms of self-help remedies that can help to relieve the problem of elderly insomnia.
Tai Chi has definite advantages to be developed as self-help therapy in older adults. Tai Chi, a traditional form of Chinese fitness exercise, is a unique form of physical activity of low impact and slow body movement, which includes a meditation component. It is a moderate type of exercise that is well perceived to be suitable for regular practice by older population. It is expected that Tai Chi is more acceptable to the elderly patients to be incorporated with their daily life as an instant approach for remedying insomnia relative to the conventional clinical treatment such as CBT. Additional advantages of Tai Chi include low-cost and can be conveniently practiced at any time and any place without requirement for extensive facilities. Certainly, the practice of Tai Chi is more accessible than the conventional CBT treatment, which facilitates the large-scale use of Tai Chi to relieve insomnia in elderly population. Furthermore, Tai Chi can be practiced individually or in a group. If practicing in a group, Tai Chi provides additional benefit by serving as a vehicle for establishing social interaction through which older people can establish friendship and gain supports from other seniors.
Tai Chi has a number of beneficial effects on geriatric health and fitness. These health benefits include improvements of aerobic fitness, energy metabolism, muscular strength and balance. In addition to the improvements of cardiorespiratory function, bone loss, posture stability and flexibility, Tai Chi exercise has also been shown to improve psychological well-being via relieving symptoms of anxiety and depression and reducing mood disturbances. All these physical and psychological advantages of Tai Chi cooperatively support its prescription to the senior population.
Tai Chi has been preliminarily demonstrated to improve sleep in older people. Favorable effects on sleep parameters have been reported in geriatric following 12 weeks to 6 months of Tai Chi training. The self-reported sleep quality is demonstrated to be improved by a 12-week of Tai Chi intervention in the senior residents in elderly home. Favorable effects of 12-week of Tai Chi training in patients with chronic heart failure are reported by showing the enhancement of sleep stability as assessed by sleep spectrogram. A longer period (6-month) of Tai Chi training has also been shown to improve the Pittsburgh Sleep Quality Index (PSQI)-indicated sleep quality in community-dwelling older adults. In older subjects with moderate sleep complaint or sleep-disturbance, 24/25-week of Tai Chi training is shown to improve the self-rated sleep quality, habitual sleep efficiency, sleep duration, and sleep disturbance.
All these preliminary data collectively indicate the beneficial effects of Tai Chi on improving sleep in geriatric population. Nonetheless, all these studies have a common design limitation, which is the lack of direct objective sleep measures. With the study limitation and research gaps, the present project is proposed to examine the therapeutic effects of Tai Chi on chronic insomnia in elderly by including objective sleep measures. The findings of this project are expected to have impact to unveil the efficacy of Tai Chi to alleviate elderly insomnia, which has been an epidemic healthcare problem that necessitates to be tackled promptly.
- Conditions
- Insomnia, Poor Sleeping Quality
- Being tested
- Generic Fitness, Tai Chi Intervention
- Keywords
- Insomnia, Sleeping, Quality
- 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.
Generic FitnessOther
Subjects in this group will receive three fitness lessons in a week while each session last for 1 hour for 12 weeks
Tai Chi InterventionOther
Subjects in this group will receive three tai chi lessons in a week while each session last for 1 hour for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Subjects in this group do not received any intervention. |
| Tai Chi Intervention | Active comparator | Subjects in this group will receive three tai chi lessons in a week while each session last for 1 hour for 12 weeks Receives: Other: Tai Chi Intervention |
| Generic Fitness Intervention | Placebo comparator | Subjects in this group will receive three fitness lessons in a week while each session last for 1 hour for 12 weeks Receives: Other: Generic Fitness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actigraphy-measured sleep onset latency
Objectively measured sleep onset latency (min)
Measured: Immediately after completion of the 12 weeks intervention
Actigraphy-measured sleep efficiency
Objectively measured sleep efficiency (%)
Measured: Immediately after completion of the 12 weeks intervention
Actigraphy-measured wake time after sleep onset
Objectively measured wake time after sleep onset (min)
Measured: Immediately after completion of the 12 weeks intervention
Actigraphy-measured total sleep time
Objectively measured total sleep time (min)
Measured: Immediately after completion of the 12 weeks intervention
Actigraphy-measured number of awakening
Objectively measured number of awakening (number of times) after sleep onset
Measured: Immediately after completion of the 12 weeks intervention
Actigraphy-measured average wake time
Objectively measured average wake time (min) of all awaken time after sleep onset
Measured: Immediately after completion of the 12 weeks intervention
Actigraphy-measured sleep onset latency
Objectively measured sleep onset latency (min)
Measured: 24 months after the completion of intervention
Actigraphy-measured Sleep efficiency
Objectively measured sleep efficiency (%)
Measured: 24 months after the completion of intervention
Actigraphy-measured wake time after sleep onset
Objectively measured wake time after sleep onset (min)
Measured: 24 months after the completion of intervention
Actigraphy-measured total sleep time
Objectively measured total sleep time (min)
Measured: 24 months after the completion of intervention
Actigraphy-measured number of awakening
Objectively measured number of awakening (number of times) after sleep onset
Measured: 24 months after the completion of intervention
Actigraphy-measured average wake time
Objectively measured average wake time (min) of all awaken time after sleep onset
Measured: 24 months after the completion of intervention
Secondary outcomes (6)
Score of Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index is a questionnaire that assess sleeping quality with scale ranged from 0 to 21. (A smaller score suggests a better sleep quality)
Measured: Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
Change in dose of Sleep Medication
The change in dose of sleep medication used by the subjects after intervention.
Measured: Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
Score of Insomnia Severity Index
Insomnia Severity Index is a questionnaire that assess sleeping quality with scale ranged from 0 to 28. (A smaller score suggests a better sleep quality)
Measured: Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
7-day Sleep Diary
Self-recorded sleep parameters (sleep onset latency, sleep efficiency, total sleep time, wake time after sleep onset, number of awakening and average awaken time)
Measured: Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
Treatment response rate
The percentage of participants that have their Score of Pittsburgh Sleep Quality Index reduced by at least 5 points
Measured: Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
Remission rate of insomnia
The percentage of participants that reached to remission of chronic insomnia according to DSM-5Immediately after the completion of the 12-week intervention
Measured: Immediately after completion of the 12-week intervention and 24-month after the complete completion of the 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 2017
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angus Yu
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Health Bureau, Hong Kong, The University of Hong Kong, Chinese University of Hong Kong
- Responsible party
- Sponsor-investigator, Angus Yu, The Hong Kong Polytechnic University
- Investigators
- Parco MF Siu, PHD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260843
- Sponsor's protocol ID
- TaiChi and Insonmia
- Status last verified
- Jul 2020
- First submitted
- 11 Jun 2014
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices), as well as the study protocol and the statistical analysis plan, will be shared, beginning 3 months and ending 5 years following publication of the Article. Data will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to pmsiu@hku.hk to gain access, and data requestors will need to sign a data-access agreement.
Publications
Siu PM, Yu AP, Tam BT, Chin EC, Yu DS, Chung KF, Hui SS, Woo J, Fong DY, Lee PH, Wei GX, Irwin MR. Effects of Tai Chi or Exercise on Sleep in Older Adults With Insomnia: A Randomized Clinical Trial. JAMA Netw Open. 2021 Feb 1;4(2):e2037199. doi: 10.1001/jamanetworkopen.2020.37199.
PubMed 33587135
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tai Chi Training to Alleviate Insomnia in Older Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02260843
- Acronym / sponsor ID
- TaiChi and Insonmia
- Conditions
- Insomnia, Poor Sleeping Quality
- Keywords
- Insomnia, Sleeping, Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Angus YuUniversity, hospital or other
- Collaborators
- Food and Health Bureau, Hong Kong, The University of Hong Kong, Chinese University of Hong Kong
- Study start
- Aug 2014 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 9 Oct 2014 (estimated)
- 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.
Elderly insomnia is a serious public health problem. Current conventional approaches for treating insomnia are not suitable or effective in elderly population. It has been previously demonstrated that Tai Chi has definite advantages to be developed as self-help therapy in older adults and has been preliminarily demonstrated to improve sleep in older people. This project aims to evaluate the efficacy of Tai Chi training on alleviating chronic insomnia in older adults.
Detailed description
Elderly insomnia is a serious public health problem. It has been estimated over 50% of elderly have sustained sleep complaints. About 20-40% of the elderly worldwide are reported insomniac. In Hong Kong, a high proportion (38%) of older people have been reported to have sleep disorders. These figures are alarming because insomnia associates with co-morbidities including cognitive impairment, depression, mood/anxiety disorders, risks for falls, hypertension, and heart disease in elderly. It also destructively affects daily functioning by impairing the memory and reducing the attention span and response time. Most importantly, insomnia has been evidently shown to link with the increased risk of hospitalization and mortality. As the proportion of geriatric population is rapidly increasing, it is foreseeable that the socioeconomic impact of elderly insomnia to the healthcare system will be undoubtedly aggravated.
Current conventional approaches for treating insomnia are not suitable or effective in elderly population. Pharmacologic treatment has always been a concern in insomniac senior patients due to the adverse drug effects including dependence, abuse, cognitive impairment and increase in risk of falls and hip fractures. With fewer adverse effects and consistent efficacy, cognitive behavioral therapy (CBT) is taken as a more appropriate remedy for elderly insomnia. However, the operation of effective CBT for insomnia is very labor demanding and cost-ineffective. The large-scale use of CBT for elderly insomnia is not feasible due to the shortage of CBT specialty-trained healthcare providers and the high treatment cost. The limited availability of CBT treatment is far insufficient to match with the increasingly large demand of insomniac elderly. There is another problem with the conventional approaches. It is observed that most of the insomnia sufferers would not seek timely clinical consultation and they tend to initiate self-help treatments when facing the problem of insomnia. This situation is suggested to be more common in Chinese elderly due to the traditional Confucius philosophy of reservation and quietness probably drive them more likely to keep the problem to themselves and become reluctant to seek prompt clinical help until serious medical symptom occurs. Given the prevalence of elderly insomnia is already high and keeps increasing, there is an urgent need to explore other effective therapeutic modalities preferably in forms of self-help remedies that can help to relieve the problem of elderly insomnia.
Tai Chi has definite advantages to be developed as self-help therapy in older adults. Tai Chi, a traditional form of Chinese fitness exercise, is a unique form of physical activity of low impact and slow body movement, which includes a meditation component. It is a moderate type of exercise that is well perceived to be suitable for regular practice by older population. It is expected that Tai Chi is more acceptable to the elderly patients to be incorporated with their daily life as an instant approach for remedying insomnia relative to the conventional clinical treatment such as CBT. Additional advantages of Tai Chi include low-cost and can be conveniently practiced at any time and any place without requirement for extensive facilities. Certainly, the practice of Tai Chi is more accessible than the conventional CBT treatment, which facilitates the large-scale use of Tai Chi to relieve insomnia in elderly population. Furthermore, Tai Chi can be practiced individually or in a group. If practicing in a group, Tai Chi provides additional benefit by serving as a vehicle for establishing social interaction through which older people can establish friendship and gain supports from other seniors.
Tai Chi has a number of beneficial effects on geriatric health and fitness. These health benefits include improvements of aerobic fitness, energy metabolism, muscular strength and balance. In addition to the improvements of cardiorespiratory function, bone loss, posture stability and flexibility, Tai Chi exercise has also been shown to improve psychological well-being via relieving symptoms of anxiety and depression and reducing mood disturbances. All these physical and psychological advantages of Tai Chi cooperatively support its prescription to the senior population.
Tai Chi has been preliminarily demonstrated to improve sleep in older people. Favorable effects on sleep parameters have been reported in geriatric following 12 weeks to 6 months of Tai Chi training. The self-reported sleep quality is demonstrated to be improved by a 12-week of Tai Chi intervention in the senior residents in elderly home. Favorable effects of 12-week of Tai Chi training in patients with chronic heart failure are reported by showing the enhancement of sleep stability as assessed by sleep spectrogram. A longer period (6-month) of Tai Chi training has also been shown to improve the Pittsburgh Sleep Quality Index (PSQI)-indicated sleep quality in community-dwelling older adults. In older subjects with moderate sleep complaint or sleep-disturbance, 24/25-week of Tai Chi training is shown to improve the self-rated sleep quality, habitual sleep efficiency, sleep duration, and sleep disturbance.
All these preliminary data collectively indicate the beneficial effects of Tai Chi on improving sleep in geriatric population. Nonetheless, all these studies have a common design limitation, which is the lack of direct objective sleep measures. With the study limitation and research gaps, the present project is proposed to examine the therapeutic effects of Tai Chi on chronic insomnia in elderly by including objective sleep measures. The findings of this project are expected to have impact to unveil the efficacy of Tai Chi to alleviate elderly insomnia, which has been an epidemic healthcare problem that necessitates to be tackled promptly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Subjects in this group do not received any intervention. |
| Tai Chi Intervention | Active comparator | Other: Tai Chi InterventionSubjects in this group will receive three tai chi lessons in a week while each session last for 1 hour for 12 weeks |
| Generic Fitness Intervention | Placebo comparator | Other: Generic FitnessSubjects in this group will receive three fitness lessons in a week while each session last for 1 hour for 12 weeks |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 60 years or older
- ethnic Chinese
- fulfill the DSM-V criteria for chronic insomnia including difficulties to initiate sleep, maintain sleep or non-restorative sleep with complaint of impairment of daytime functioning, sleep difficulty occurs at least 3 nights per week and is present for at least three months.
Key exclusion criteria (6 listed)
- cannot walk without assistive tool (e.g., cane)
- any serious somatic condition that prevent participation for Tai Chi/generic fitness activities
- current regular practicing of moderate exercise training or Tai Chi (>3 times a week of >30-min per session)
- any serious chronic diseases known to affect sleep (e.g., cancer and autoimmune diseases)
- under treatment of serious diseases known to affect sleep (e.g., cancer chemotherapy)
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 |
|---|---|---|
| Generic FitnessSubjects in this group will receive three fitness lessons in a week while each session last for 1 hour for 12 weeks | Other | Generic Fitness Intervention |
| Tai Chi InterventionSubjects in this group will receive three tai chi lessons in a week while each session last for 1 hour for 12 weeks | Other | Tai Chi Intervention |
Primary outcome
Actigraphy-measured sleep onset latency
Time frame: Immediately after completion of the 12 weeks intervention
Objectively measured sleep onset latency (min)
Actigraphy-measured sleep efficiency
Time frame: Immediately after completion of the 12 weeks intervention
Objectively measured sleep efficiency (%)
Actigraphy-measured wake time after sleep onset
Time frame: Immediately after completion of the 12 weeks intervention
Objectively measured wake time after sleep onset (min)
Actigraphy-measured total sleep time
Time frame: Immediately after completion of the 12 weeks intervention
Objectively measured total sleep time (min)
Actigraphy-measured number of awakening
Time frame: Immediately after completion of the 12 weeks intervention
Objectively measured number of awakening (number of times) after sleep onset
Actigraphy-measured average wake time
Time frame: Immediately after completion of the 12 weeks intervention
Objectively measured average wake time (min) of all awaken time after sleep onset
Actigraphy-measured sleep onset latency
Time frame: 24 months after the completion of intervention
Objectively measured sleep onset latency (min)
Actigraphy-measured Sleep efficiency
Time frame: 24 months after the completion of intervention
Objectively measured sleep efficiency (%)
Actigraphy-measured wake time after sleep onset
Time frame: 24 months after the completion of intervention
Objectively measured wake time after sleep onset (min)
Actigraphy-measured total sleep time
Time frame: 24 months after the completion of intervention
Objectively measured total sleep time (min)
Actigraphy-measured number of awakening
Time frame: 24 months after the completion of intervention
Objectively measured number of awakening (number of times) after sleep onset
Actigraphy-measured average wake time
Time frame: 24 months after the completion of intervention
Objectively measured average wake time (min) of all awaken time after sleep onset
6 secondary outcomes
Score of Pittsburgh Sleep Quality Index
Time frame: Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
Change in dose of Sleep Medication
Time frame: Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
Score of Insomnia Severity Index
Time frame: Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
7-day Sleep Diary
Time frame: Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
Treatment response rate
Time frame: Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
Remission rate of insomnia
Time frame: Immediately after completion of the 12-week intervention and 24-month after the complete completion of the 12-week intervention
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 22 Jul 2020.
- Derived from this study: PubMed 33587135Siu PM, Yu AP, Tam BT, Chin EC, Yu DS, Chung KF, Hui SS, Woo J, Fong DY, Lee PH, Wei GX, Irwin MR. Effects of Tai Chi or Exercise on Sleep in Older Adults With Insomnia: A Randomized Clinical Trial. JAMA Netw Open. 2021 Feb 1;4(2):e2037199. doi: 10.1001/jamanetworkopen.2020.37199.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices), as well as the study protocol and the statistical analysis plan, will be shared, beginning 3 months and ending 5 years following publication of the Article. Data will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to pmsiu@hku.hk to gain access, and data requestors will need to sign a data-access agreement.
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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.
Parco MF Siu, PHD principal investigator
The Hong Kong Polytechnic University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Generic Fitness and Tai Chi Intervention in people with Insomnia and Poor Sleeping Quality, run by Angus Yu at 3 sites 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 6 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 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
Actigraphy-measured sleep onset latency (time frame: Immediately after completion of the 12 weeks intervention). The study lists 12 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 NCT02260843, which also lists 1 linked publication.
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 22 Jul 2020.