Clinical trial NCT05396092: The Effects of an Integrated Mindfulness-based Tai Chi Chuan Program on Sleep Disturbance Among Community-dwelling Elderly People
Official title: The Effects of an Integrated Mindfulness-based Tai Chi Chuan Program on Sleep Disturbance Among Community-dwelling Elderly People: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Elderly
Sleep
Mindfulness
Tai Chi Chuan
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Food and Health Bureau, Hong Kong
First posted: 2022-05-31
Enrollment: 256
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: The trial aims to evaluate the effects of an integrated form of mindfulness-based Tai Chi Chuan (MBTCC) program and the underlying mechanisms of the beneficial effects on sleep disturbance over 12-month follow-up in community-dwelling elderly people.


Eligibility criteria: Inclusion criteria:

* Aged 60 years or above;
* Classified as experiencing sleep disturbances (indication of poor sleep quality through a score \>5 in the Pittsburgh Sleep Quality Index);
* Primary education level or above and able to communicate in Cantonese;
* Able to give informed consent; and
* No previous experience with meditation or other mind-body techniques (e.g., tai chi or yoga).

Exclusion criteria:

• Comorbid diagnoses of schizophrenia, schizoaffective disorder, substance misuse, organic brain syndrome, or intellectual disabilities.

Primary outcomes:
measure: the Insomnia Severity Index
timeFrame: at baseline (T1)
measure: the Insomnia Severity Index
timeFrame: In the 8th week from baseline (T2)
measure: the Insomnia Severity Index
timeFrame: six months after T2 (T3)
measure: the Insomnia Severity Index
timeFrame: one year after T2 (T4)
Secondary outcomes:
measure: the Multidimensional Assessment of Interoceptive Awareness scale
timeFrame: at baseline (T1)
measure: the Multidimensional Assessment of Interoceptive Awareness scale
timeFrame: In the 8th week from baseline (T2)
measure: the Multidimensional Assessment of Interoceptive Awareness scale
timeFrame: six months after T2 (T3)
measure: the Multidimensional Assessment of Interoceptive Awareness scale
timeFrame: one year after T2 (T4)
measure: Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)
timeFrame: at baseline (T1)
measure: Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)
timeFrame: In the 8th week from baseline (T2)
measure: Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)
timeFrame: six months after T2 (T3)
measure: Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)
timeFrame: one year after T2 (T4)
Other outcomes:
measure: the Chinese (Hong Kong) Short-Form-12
timeFrame: at baseline (T1)
measure: the Chinese (Hong Kong) Short-Form-12
timeFrame: In the 8th week from baseline (T2)
measure: the Chinese (Hong Kong) Short-Form-12
timeFrame: six months after T2 (T3)
measure: the Chinese (Hong Kong) Short-Form-12
timeFrame: one year after T2 (T4)
measure: the rumination subscale from the Rumination-Reflection Questionnaire
timeFrame: at baseline (T1)
measure: the rumination subscale from the Rumination-Reflection Questionnaire
timeFrame: In the 8th week from baseline (T2)
measure: the rumination subscale from the Rumination-Reflection Questionnaire
timeFrame: six months after T2 (T3)
measure: the rumination subscale from the Rumination-Reflection Questionnaire
timeFrame: one year after T2 (T4)
measure: the hyperarousal scale
timeFrame: at baseline (T1)
measure: the hyperarousal scale
timeFrame: In the 8th week from baseline (T2)
measure: the hyperarousal scale
timeFrame: six months after T2 (T3)
measure: the hyperarousal scale
timeFrame: one year after T2 (T4)
Locations:
city: Kowloon
country: Hong Kong
facility: Hong Kong Polytechnic University
Study officials:
References:
citation: Chan SH, Ng SM, Yu CH, Chan CM, Wang SM, Chan WC. The effects of an integrated mindfulness-based tai chi chuan programme on sleep disturbance among community-dwelling elderly people: protocol for a randomized controlled trial. Trials. 2022 Sep 24;23(1):808. doi: 10.1186/s13063-022-06737-4.