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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]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic disease

Condition category

Condition code

Public Health

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]

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]

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]

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]

Mental wellbeing as measured by mean scores on generalized anxiety disorder 7 (GAD-7).

Timepoint [1]

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]

Work productivity and activity assessment (WPAI:SHP)

Timepoint [2]

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]

Pain as measured by mean scores on the visual analogue scale (VAS).

Timepoint [3]

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]

Objective measures include flexibility as measured by the finger to floor distance (FFD).

Timepoint [4]

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]

People diagnosed with pre-diabetes or diabetes, their HbA1C and fasting BGL will also be measured via test kits.

Timepoint [5]

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]

Participants’ experiences of participating in the trial

Timepoint [6]

This outcome will be obtained via a study specific online survey post intervention (post 12-week trial, week 13) (T1).

Secondary outcome [7]

Mental wellbeing as measured by mean scores on the patient health questionnaire (PHQ-9).

Timepoint [7]

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]

Pain as measured by mean scores on the McGill pain questionnaire (MPQ).

Timepoint [8]

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]

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]

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]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Edith Cowan University

Address [1]

270 Joondalup Drive, Joondalup WA 6027

Country [1]

Australia

Primary sponsor type

University

Name

Edith Cowan University

Address

270 Joondalup Drive, Joondalup WA 6027

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Edith Cowan University’s Human Research Ethics Committee

Ethics committee address [1]

270 Joondalup Dr, Joondalup WA6027

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/12/2021

Approval date [1]

Ethics approval number [1]

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

Dr Carol Chunfeng Wang

Address

Edith Cowan University
270 Joondalup Dr, Joondalup, WA 6027

Country

Australia

Phone

+61 8 63043589

Fax

[email protected]

Contact person for public queries

Name

Carol Chunfeng Wang

Address

Edith Cowan University
270 Joondalup Dr, Joondalup, WA 6027

Country

Australia

Phone

+61 8 63043589

Fax

[email protected]

Contact person for scientific queries

Name

Carol Chunfeng Wang

Address

Edith Cowan University
270 Joondalup Dr, Joondalup, WA 6027

Country

Australia

Phone

+61 8 63043589

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Effects 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.	2022	https://dx.doi.org/10.1371/journal.pone.0270212

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically