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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.

Completed

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

Official record
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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

Other trials in China

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.

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 groups in NCT02260843
Study groupRoleWhat they receive
ControlNo interventionSubjects in this group do not received any intervention.
Tai Chi InterventionActive comparatorSubjects 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 InterventionPlacebo comparatorSubjects 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.

  1. Actigraphy-measured sleep onset latency

    Objectively measured sleep onset latency (min)

    Measured: Immediately after completion of the 12 weeks intervention

  2. Actigraphy-measured sleep efficiency

    Objectively measured sleep efficiency (%)

    Measured: Immediately after completion of the 12 weeks intervention

  3. Actigraphy-measured wake time after sleep onset

    Objectively measured wake time after sleep onset (min)

    Measured: Immediately after completion of the 12 weeks intervention

  4. Actigraphy-measured total sleep time

    Objectively measured total sleep time (min)

    Measured: Immediately after completion of the 12 weeks intervention

  5. 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

  6. 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

  7. Actigraphy-measured sleep onset latency

    Objectively measured sleep onset latency (min)

    Measured: 24 months after the completion of intervention

  8. Actigraphy-measured Sleep efficiency

    Objectively measured sleep efficiency (%)

    Measured: 24 months after the completion of intervention

  9. Actigraphy-measured wake time after sleep onset

    Objectively measured wake time after sleep onset (min)

    Measured: 24 months after the completion of intervention

  10. Actigraphy-measured total sleep time

    Objectively measured total sleep time (min)

    Measured: 24 months after the completion of intervention

  11. Actigraphy-measured number of awakening

    Objectively measured number of awakening (number of times) after sleep onset

    Measured: 24 months after the completion of intervention

  12. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted9 Oct 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionFeb 2017
  4. Study completionAug 2018

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
Single blind
Who is masked
Outcomes assessor
Enrolment
320 participants (actual)
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

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.

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