Clinical trial NCT02260843: Efficacy of Tai Chi Training on Insomnia in Older Adults
Official title: Efficacy of Tai Chi Training to Alleviate Insomnia in Older Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Poor Sleeping Quality
Keywords: Insomnia
Sleeping
Quality
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Food and Health Bureau, Hong Kong
name: The University of Hong Kong
name: Chinese University of Hong Kong
First posted: 2014-10-09
Enrollment: 320
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Actigraphy-measured sleep onset latency
timeFrame: Immediately after completion of the 12 weeks intervention
measure: Actigraphy-measured sleep efficiency
timeFrame: Immediately after completion of the 12 weeks intervention
measure: Actigraphy-measured wake time after sleep onset
timeFrame: Immediately after completion of the 12 weeks intervention
measure: Actigraphy-measured total sleep time
timeFrame: Immediately after completion of the 12 weeks intervention
measure: Actigraphy-measured number of awakening
timeFrame: Immediately after completion of the 12 weeks intervention
measure: Actigraphy-measured average wake time
timeFrame: Immediately after completion of the 12 weeks intervention
measure: Actigraphy-measured sleep onset latency
timeFrame: 24 months after the completion of intervention
measure: Actigraphy-measured Sleep efficiency
timeFrame: 24 months after the completion of intervention
measure: Actigraphy-measured wake time after sleep onset
timeFrame: 24 months after the completion of intervention
measure: Actigraphy-measured total sleep time
timeFrame: 24 months after the completion of intervention
measure: Actigraphy-measured number of awakening
timeFrame: 24 months after the completion of intervention
measure: Actigraphy-measured average wake time
timeFrame: 24 months after the completion of intervention
Secondary outcomes:
measure: Score of Pittsburgh Sleep Quality Index
timeFrame: Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
measure: Change in dose of Sleep Medication
timeFrame: Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
measure: Score of Insomnia Severity Index
timeFrame: Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
measure: 7-day Sleep Diary
timeFrame: Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
measure: Treatment response rate
timeFrame: Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
measure: Remission rate of insomnia
timeFrame: Immediately after completion of the 12-week intervention and 24-month after the complete completion of the 12-week intervention
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Chinese University of Hong Kong
state: Hong Kong
city: Hong Kong
country: China
facility: The University of Hong Kong
state: Hong Kong
city: Hong Kong
country: China
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Parco MF Siu, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.