Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000042741p
Ethics application status
Submitted, not yet approved
Date submitted
26/12/2021
Date registered
17/01/2022
Date last updated
17/01/2022
Date data sharing statement initially provided
17/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Is Tai Chi an effective approach for improving the quality of life, physical function, and mental wellbeing of adults with chronic disease?
Scientific title
The therapeutic effect of a 12-week Tai Chi training program on the quality of life, mental wellbeing, and physical function of adults with chronic disease: a single-blind, double-armed, randomised controlled trial
Secondary ID [1] 306117 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic disease 324793 0
Condition category
Condition code
Public Health 322243 322243 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In addition to usual care (e.g., other exercise), participants will receive a Tai Chia training program that is led by a qualified academic at Edith Cowan University. The program involves twelve weeks of group Tai Chi training sessions, with 45 minutes per session twice a week.
The attendance records will be used to monitor adherence to the intervention.
Intervention code [1] 322530 0
Treatment: Other
Comparator / control treatment
The waiting list control group will receive usual care (e.g., other exercise). This group will be offered the intervention in week 14 (after 12-week intervention and 1 week run in period).
Control group
Active

Outcomes
Primary outcome [1] 330013 0
Quality of life as measured by mean scores on the 12-item Short Form Health Survey (SF-12) and the EuroQoL (EQ-5D).
Timepoint [1] 330013 0
This outcome will be obtained via two online study specific surveys: at baseline (T0) and post intervention (post 12-week trial, week 13) (T1).
Secondary outcome [1] 404583 0
Mental wellbeing as measured by mean scores on generalized anxiety disorder 7 (GAD-7).
Timepoint [1] 404583 0
This outcome will be measured via two study specific online surveys at baseline (T0) and post intervention (post 12-week trial, week 13) (T1).
Secondary outcome [2] 404584 0
Work productivity and activity assessment (WPAI:SHP)
Timepoint [2] 404584 0
This outcome will be obtained via two study specific online surveys: at baseline (T0) and post intervention (post 12-week trial, week 13) (T1).
Secondary outcome [3] 404585 0
Pain as measured by mean scores on the visual analogue scale (VAS).
Timepoint [3] 404585 0
This outcome will be obtained via two study specific online surveys: at baseline (T0) and post intervention (post 12-week trial, week 13) (T1).
Secondary outcome [4] 404586 0
Objective measures include flexibility as measured by the finger to floor distance (FFD).
Timepoint [4] 404586 0
These outcomes will be measured onsite in the clinic prior to (T0) and post-intervention (post 12-week trial, week 13) (T1).
Secondary outcome [5] 404587 0
People diagnosed with pre-diabetes or diabetes, their HbA1C and fasting BGL will also be measured via test kits.
Timepoint [5] 404587 0
These outcomes will be measured onsite in the clinic prior to (T0) and post-intervention (post 12-week trial, week 13) (T1).
Secondary outcome [6] 404589 0
Participants’ experiences of participating in the trial
Timepoint [6] 404589 0
This outcome will be obtained via a study specific online survey post intervention (post 12-week trial, week 13) (T1).
Secondary outcome [7] 404964 0
Mental wellbeing as measured by mean scores on the patient health questionnaire (PHQ-9).
Timepoint [7] 404964 0
This outcome will be measured via two study specific online surveys at baseline (T0) and post intervention (post 12-week trial, week 13) (T1).
Secondary outcome [8] 404965 0
Pain as measured by mean scores on the McGill pain questionnaire (MPQ).
Timepoint [8] 404965 0
This outcome will be obtained via two study specific online surveys: at baseline (T0) and post intervention (post 12-week trial, week 13) (T1).
Secondary outcome [9] 404966 0
Objective measures include obesity as measured by mean scores on body mass index (BMI). Participant’s height, weight will be measured via digital scales. BMI is weight in kilograms divided by height in meters squared. Because height is commonly measured in centimetres, divide height in centimetres by 100 to obtain height in meters.
Timepoint [9] 404966 0
These outcomes will be measured onsite in the clinic prior to (T0) and post-intervention (post 12-week trial, week 13) (T1).
Secondary outcome [10] 404967 0
Objective measures include Vital signs (blood pressure, heart rate, respiratory rate, temperate, and oxygen saturation) as measured by a blood pressure monitor, tympanic, and pulse oximetry device.
Timepoint [10] 404967 0
These outcomes will be measured onsite in the clinic prior to (T0) and post-intervention (post 12-week trial, week 13) (T1).

Eligibility
Key inclusion criteria
(1) adults who are aged 18-65 years,
(2) diagnosed with one or more chronic disease,
(3) having no physical and mental limitations prohibiting exercise, and
(4) willing and able to consent for participation in the trial.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People who are pregnant or with a serious health conditions that incapable of completing 12-week Tai Chi exercise training will be eligible to participate.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation will be performed by an independent, blinded statistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence number of each participant will be computer generated using a randomised block approach. The block sizes will not be disclosed to ensure concealment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis of the pre- post-intervention data will consist of Generalised Linear Mixed Modelling through R software to detect effects of the intervention versus the control groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/05/2022
Actual
Date of last participant enrolment
Anticipated
28/02/2025
Actual
Date of last data collection
Anticipated
30/05/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 310468 0
University
Name [1] 310468 0
Edith Cowan University
Country [1] 310468 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive, Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 311618 0
None
Name [1] 311618 0
Address [1] 311618 0
Country [1] 311618 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310099 0
Edith Cowan University’s Human Research Ethics Committee
Ethics committee address [1] 310099 0
270 Joondalup Dr, Joondalup WA6027
Ethics committee country [1] 310099 0
Australia
Date submitted for ethics approval [1] 310099 0
01/12/2021
Approval date [1] 310099 0
Ethics approval number [1] 310099 0

Summary
Brief summary
This study aims to evaluate a 12-week Tai Chi training program as an intervention to add evidence on the therapeutic effect of a non-pharmacological approach in chronic disease management. We hypothesize that QoL, physical function, and mental wellbeing in Tai Chi group is better than the waiting list control group. We hope that the results of our research can be used to inform our knowledge about how to better manage chronic diseases. There are no foreseeable risks associated with this research project.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116466 0
Dr Carol Chunfeng Wang
Address 116466 0
Edith Cowan University
270 Joondalup Dr, Joondalup, WA 6027
Country 116466 0
Australia
Phone 116466 0
+61 8 63043589
Fax 116466 0
Email 116466 0
c.wang@ecu.edu.au
Contact person for public queries
Name 116467 0
Dr Carol Chunfeng Wang
Address 116467 0
Edith Cowan University
270 Joondalup Dr, Joondalup, WA 6027
Country 116467 0
Australia
Phone 116467 0
+61 8 63043589
Fax 116467 0
Email 116467 0
c.wang@ecu.edu.au
Contact person for scientific queries
Name 116468 0
Dr Carol Chunfeng Wang
Address 116468 0
Edith Cowan University
270 Joondalup Dr, Joondalup, WA 6027
Country 116468 0
Australia
Phone 116468 0
+61 8 63043589
Fax 116468 0
Email 116468 0
c.wang@ecu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of Tai Chi on the quality of life, mental wellbeing, and physical function of adults with chronic diseases: Protocol for a single-blind, two-armed, randomised controlled trial.2022https://dx.doi.org/10.1371/journal.pone.0270212
N.B. These documents automatically identified may not have been verified by the study sponsor.