- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02260843
Efficacy of Tai Chi Training on Insomnia in Older Adults
Efficacy of Tai Chi Training to Alleviate Insomnia in Older Adults: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, China, 852
- The Hong Kong Polytechnic University
-
-
Hong Kong
-
Hong Kong, Hong Kong, China, 852
- The Chinese University of Hong Kong
-
Hong Kong, Hong Kong, China, 852
- The University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
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 |
---|---|
No Intervention: Control
Subjects in this group do not received any intervention.
|
|
Active Comparator: Tai Chi Intervention
Subjects in this group will receive three tai chi lessons in a week while each session last for 1 hour for 12 weeks
|
Subjects in this group will receive three tai chi lessons in a week while each session last for 1 hour for 12 weeks
|
Placebo Comparator: Generic Fitness Intervention
Subjects in this group will receive three fitness lessons in a week while each session last for 1 hour for 12 weeks
|
Subjects in this group will receive three fitness lessons in a week while each session last for 1 hour for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Actigraphy-measured sleep onset latency
Time Frame: Immediately after completion of the 12 weeks intervention
|
Objectively measured sleep onset latency (min)
|
Immediately after completion of the 12 weeks intervention
|
Actigraphy-measured sleep efficiency
Time Frame: Immediately after completion of the 12 weeks intervention
|
Objectively measured sleep efficiency (%)
|
Immediately after completion of the 12 weeks intervention
|
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)
|
Immediately after completion of the 12 weeks intervention
|
Actigraphy-measured total sleep time
Time Frame: Immediately after completion of the 12 weeks intervention
|
Objectively measured total sleep time (min)
|
Immediately after completion of the 12 weeks intervention
|
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
|
Immediately after completion of the 12 weeks intervention
|
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
|
Immediately after completion of the 12 weeks intervention
|
Actigraphy-measured sleep onset latency
Time Frame: 24 months after the completion of intervention
|
Objectively measured sleep onset latency (min)
|
24 months after the completion of intervention
|
Actigraphy-measured Sleep efficiency
Time Frame: 24 months after the completion of intervention
|
Objectively measured sleep efficiency (%)
|
24 months after the completion of intervention
|
Actigraphy-measured wake time after sleep onset
Time Frame: 24 months after the completion of intervention
|
Objectively measured wake time after sleep onset (min)
|
24 months after the completion of intervention
|
Actigraphy-measured total sleep time
Time Frame: 24 months after the completion of intervention
|
Objectively measured total sleep time (min)
|
24 months after the completion of intervention
|
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
|
24 months after the completion of intervention
|
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
|
24 months after the completion of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score of Pittsburgh Sleep Quality Index
Time Frame: Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
|
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)
|
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
|
The change in dose of sleep medication used by the subjects after intervention.
|
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
|
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)
|
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
|
Self-recorded sleep parameters (sleep onset latency, sleep efficiency, total sleep time, wake time after sleep onset, number of awakening and average awaken time)
|
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
|
The percentage of participants that have their Score of Pittsburgh Sleep Quality Index reduced by at least 5 points
|
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
|
The percentage of participants that reached to remission of chronic insomnia according to DSM-5Immediately after the completion of the 12-week intervention
|
Immediately after completion of the 12-week intervention and 24-month after the complete completion of the 12-week intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Parco MF Siu, PHD, The Hong Kong Polytechnic University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TaiChi and Insonmia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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.
Clinical Trials on Insomnia
-
Leiden UniversityBioClock Consortium; Caring UniveristiesCompleted
-
National Science Council, TaiwanCompleted
-
Sunshine Lake Pharma Co., Ltd.Unknown
-
Pfizer's Upjohn has merged with Mylan to form Viatris...Completed
-
Massachusetts General HospitalNational Institutes of Health (NIH)Completed
-
IpsenCompletedThe Effectiveness of Circadin in Improving Quality of Sleep in Patients Aged 55 or Over (QUALISLEEP)InsomniaRussian Federation
-
Charite University, Berlin, GermanyCompleted
-
Roxane LaboratoriesCompleted
-
Butler HospitalSunovionCompleted
Clinical Trials on Tai Chi Intervention
-
Edward Via Virginia College of Osteopathic MedicineNational Center for Complementary and Integrative Health (NCCIH); The University...RecruitingKnee OsteoarthritisUnited States
-
VA Office of Research and DevelopmentBoston University; Tufts Medical CenterActive, not recruiting
-
The University of Hong KongQueen Mary Hospital, Hong KongRecruitingTai-Chi and Aerobic Exercise to Improve Emotional Symptom Cluster in Late-stage Lung Cancer PatientsAdvanced Lung Non-Small Cell CarcinomaHong Kong
-
Beni-Suef UniversityRecruiting
-
Appalachian State UniversityCompleted
-
Harvard University Faculty of MedicineBeth Israel Deaconess Medical Center; Brigham and Women's HospitalCompleted
-
Beijing Anzhen HospitalNot yet recruitingRenal Insufficiency | Coronary Heart Disease (CHD)China
-
Lidian ChenPeking University Third HospitalNot yet recruiting
-
The Hong Kong Polytechnic UniversityFood and Health Bureau, Hong KongRecruitingSleep | Elderly | Mindfulness | Tai Chi ChuanHong Kong
-
Massachusetts General HospitalNational Center for Complementary and Integrative Health (NCCIH)Completed