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Efficacy of Tai Chi Training on Insomnia in Older Adults

Primary Purpose

Insomnia, Poor Sleeping Quality

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Generic Fitness
Tai Chi Intervention
Sponsored by
Angus Yu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Sleeping, Quality

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Chinese University of Hong Kong
  • The University of Hong Kong
  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Placebo Comparator

Arm Label

Control

Tai Chi Intervention

Generic Fitness Intervention

Arm Description

Subjects in this group do not received any 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 fitness lessons in a week while each session last for 1 hour for 12 weeks

Outcomes

Primary Outcome Measures

Actigraphy-measured sleep onset latency
Objectively measured sleep onset latency (min)
Actigraphy-measured sleep efficiency
Objectively measured sleep efficiency (%)
Actigraphy-measured wake time after sleep onset
Objectively measured wake time after sleep onset (min)
Actigraphy-measured total sleep time
Objectively measured total sleep time (min)
Actigraphy-measured number of awakening
Objectively measured number of awakening (number of times) after sleep onset
Actigraphy-measured average wake time
Objectively measured average wake time (min) of all awaken time after sleep onset
Actigraphy-measured sleep onset latency
Objectively measured sleep onset latency (min)
Actigraphy-measured Sleep efficiency
Objectively measured sleep efficiency (%)
Actigraphy-measured wake time after sleep onset
Objectively measured wake time after sleep onset (min)
Actigraphy-measured total sleep time
Objectively measured total sleep time (min)
Actigraphy-measured number of awakening
Objectively measured number of awakening (number of times) after sleep onset
Actigraphy-measured average wake time
Objectively measured average wake time (min) of all awaken time after sleep onset

Secondary Outcome Measures

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)
Change in dose of Sleep Medication
The change in dose of sleep medication used by the subjects after 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)
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)
Treatment response rate
The percentage of participants that have their Score of Pittsburgh Sleep Quality Index reduced by at least 5 points
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

Full Information

First Posted
June 11, 2014
Last Updated
July 21, 2020
Sponsor
Angus Yu
Collaborators
Food and Health Bureau, Hong Kong, The University of Hong Kong, Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02260843
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Angus Yu
Collaborators
Food and Health Bureau, Hong Kong, The University of Hong Kong, Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Poor Sleeping Quality
Keywords
Insomnia, Sleeping, Quality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects in this group do not received any intervention.
Arm Title
Tai Chi Intervention
Arm Type
Active Comparator
Arm Description
Subjects in this group will receive three tai chi lessons in a week while each session last for 1 hour for 12 weeks
Arm Title
Generic Fitness Intervention
Arm Type
Placebo Comparator
Arm Description
Subjects in this group will receive three fitness lessons in a week while each session last for 1 hour for 12 weeks
Intervention Type
Other
Intervention Name(s)
Generic Fitness
Intervention Description
Subjects in this group will receive three fitness lessons in a week while each session last for 1 hour for 12 weeks
Intervention Type
Other
Intervention Name(s)
Tai Chi Intervention
Intervention Description
Subjects in this group will receive three tai chi lessons in a week while each session last for 1 hour for 12 weeks
Primary Outcome Measure Information:
Title
Actigraphy-measured sleep onset latency
Description
Objectively measured sleep onset latency (min)
Time Frame
Immediately after completion of the 12 weeks intervention
Title
Actigraphy-measured sleep efficiency
Description
Objectively measured sleep efficiency (%)
Time Frame
Immediately after completion of the 12 weeks intervention
Title
Actigraphy-measured wake time after sleep onset
Description
Objectively measured wake time after sleep onset (min)
Time Frame
Immediately after completion of the 12 weeks intervention
Title
Actigraphy-measured total sleep time
Description
Objectively measured total sleep time (min)
Time Frame
Immediately after completion of the 12 weeks intervention
Title
Actigraphy-measured number of awakening
Description
Objectively measured number of awakening (number of times) after sleep onset
Time Frame
Immediately after completion of the 12 weeks intervention
Title
Actigraphy-measured average wake time
Description
Objectively measured average wake time (min) of all awaken time after sleep onset
Time Frame
Immediately after completion of the 12 weeks intervention
Title
Actigraphy-measured sleep onset latency
Description
Objectively measured sleep onset latency (min)
Time Frame
24 months after the completion of intervention
Title
Actigraphy-measured Sleep efficiency
Description
Objectively measured sleep efficiency (%)
Time Frame
24 months after the completion of intervention
Title
Actigraphy-measured wake time after sleep onset
Description
Objectively measured wake time after sleep onset (min)
Time Frame
24 months after the completion of intervention
Title
Actigraphy-measured total sleep time
Description
Objectively measured total sleep time (min)
Time Frame
24 months after the completion of intervention
Title
Actigraphy-measured number of awakening
Description
Objectively measured number of awakening (number of times) after sleep onset
Time Frame
24 months after the completion of intervention
Title
Actigraphy-measured average wake time
Description
Objectively measured average wake time (min) of all awaken time after sleep onset
Time Frame
24 months after the completion of intervention
Secondary Outcome Measure Information:
Title
Score of Pittsburgh Sleep Quality Index
Description
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)
Time Frame
Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
Title
Change in dose of Sleep Medication
Description
The change in dose of sleep medication used by the subjects after intervention.
Time Frame
Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
Title
Score of Insomnia Severity Index
Description
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)
Time Frame
Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
Title
7-day Sleep Diary
Description
Self-recorded sleep parameters (sleep onset latency, sleep efficiency, total sleep time, wake time after sleep onset, number of awakening and average awaken time)
Time Frame
Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
Title
Treatment response rate
Description
The percentage of participants that have their Score of Pittsburgh Sleep Quality Index reduced by at least 5 points
Time Frame
Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention
Title
Remission rate of insomnia
Description
The percentage of participants that reached to remission of chronic insomnia according to DSM-5Immediately after the completion of the 12-week intervention
Time Frame
Immediately after completion of the 12-week intervention and 24-month after the complete completion of the 12-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parco MF Siu, PHD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
State/Province
Hong Kong
ZIP/Postal Code
852
Country
China
Facility Name
The University of Hong Kong
City
Hong Kong
State/Province
Hong Kong
ZIP/Postal Code
852
Country
China
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
ZIP/Postal Code
852
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following publication of the Article
IPD Sharing Access Criteria
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.
Citations:
PubMed Identifier
33587135
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.
Results Reference
derived

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Efficacy of Tai Chi Training on Insomnia in Older Adults

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