Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001058460
Ethics application status
Approved
Date submitted
8/08/2016
Date registered
9/08/2016
Date last updated
13/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Long-term effects of Tai Chi in chronic obstructive pulmonary disease
Scientific title
Long-term effects of Tai Chi on exercise capacity and quality of life in chronic obstructive pulmonary disease: a pilot study
Secondary ID [1] 289897 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 299860 0
Condition category
Condition code
Respiratory 299765 299765 0 0
Chronic obstructive pulmonary disease
Physical Medicine / Rehabilitation 299766 299766 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be asked to undertake an eight-week supervised exercise program of Sun-style Tai Chi. The Tai Chi training will be delivered in a group setting, with a maximum of three participants per group, by a physiotherapist and/or physiotherapy assistant accredited in Sun-style Tai Chi training. Participants will attend two one-hour supervised Tai Chi training sessions each week, and will aim to train at a moderate level of breathlessness or exertion (equivalent to a score of three on the modified Borg 0–10 scale). To increase the training demand of Tai Chi, participants will be asked to imagine pushing against resistance during all movements or to squat lower in certain movements. Wrist weights of between 0.5-1.5 kg will be worn by participants who do not reach a moderate level of dyspnoea or exertion during training.

On completion of the supervised program, participants will then be asked to continue with a home-based, unsupervised maintenance Tai Chi program five times weekly for six months. Participants will aim to practice Tai Chi for at least 30 minutes during each home-based session, including a warm-up and cool-down. A training booklet and DVD will be provided to assist with Tai Chi practice at home. During this six-month period, participants will also receive monthly “booster” sessions of supervised Tai Chi training. There will be six one-hour “booster” sessions in total. The intensity of Tai Chi training may be adjusted during “booster” sessions to ensure that participants are exercising at a moderate level of breathlessness or exertion. The addition of monthly “booster” sessions of supervised Tai Chi training will provide additional real-time feedback during the six-month maintenance program and may enhance compliance with unsupervised home practice of Tai Chi.

Participants will be asked to record the duration and intensity of Tai Chi practice at home in a training diary during the entire intervention period. Adherence to the supervised Tai Chi training program will be monitored by recording attendance at each supervised training session and by reviewing the participants’ training diary each month. Adherence to the maintenance Tai Chi program will also be monitored using the training diary.
Intervention code [1] 295579 0
Rehabilitation
Intervention code [2] 295580 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299225 0
Exercise capacity (6-minute walk test)
Timepoint [1] 299225 0
Baseline, completion of the supervised Tai Chi program at 8 weeks, 3 months into the home-based Tai Chi maintenance program, completion of the home-based Tai Chi maintenance program at 6 months
Primary outcome [2] 299226 0
Health-related quality of life (St George’s Respiratory Questionnaire)
Timepoint [2] 299226 0
Baseline, completion of the supervised Tai Chi program at 8 weeks, 3 months into the home-based Tai Chi maintenance program, completion of the home-based Tai Chi maintenance program at 6 months
Secondary outcome [1] 326559 0
Balance (Brief-BESTest)
Timepoint [1] 326559 0
Baseline, completion of the supervised Tai Chi program at 8 weeks, 3 months into the home-based Tai Chi maintenance program, completion of the home-based Tai Chi maintenance program at 6 months
Secondary outcome [2] 326560 0
Physical activity (SenseWear Armband, Bodymedia, Pittsburgh, USA)
Timepoint [2] 326560 0
Participants will be asked to wear the SenseWear Armand for seven days, 24 hours a day, at each assessment time point: Baseline, completion of the supervised Tai Chi program at 8 weeks, 3 months into the home-based Tai Chi maintenance program, completion of the home-based Tai Chi maintenance program at 6 months. The SenseWear Armband is only to be removed for showering or if skin irritation occurs.
Secondary outcome [3] 326561 0
Self-efficacy (Patient Activation Measure)
Timepoint [3] 326561 0
Baseline, completion of the supervised Tai Chi program at 8 weeks, 3 months into the home-based Tai Chi maintenance program, completion of the home-based Tai Chi maintenance program at 6 months
Secondary outcome [4] 326562 0
Compliance with supervised and unsupervised Tai Chi training
Timepoint [4] 326562 0
Attendance during the eight-week supervised Tai Chi program, self-reported practice in a training diary during the eight-week supervised Tai Chi program, self-reported practice in a training diary during the six-month home-based Tai Chi maintenance program
Secondary outcome [5] 326563 0
Patient satisfaction with the Tai Chi training program (study-specific questionnaire)
Timepoint [5] 326563 0
Completion of the home-based unsupervised maintenance Tai Chi program at 6 months
Secondary outcome [6] 326564 0
Lung function (spirometry)
Timepoint [6] 326564 0
Baseline, completion of the supervised Tai Chi program at 8 weeks, 3 months into the home-based Tai Chi maintenance program, completion of the home-based Tai Chi maintenance program at 6 months

Eligibility
Key inclusion criteria
Medical diagnosis of chronic obstructive pulmonary disease (forced expiratory volume in one second (FEV1) / forced vital capacity ratio of < 0.7; FEV1 between 20% to 80% of predicted normal)
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Acute exacerbation of COPD in the last month; musculoskeletal, cardiovascular or neurological conditions likely to adversely affect performance during assessments or training; participation in any supervised exercise training within the last 12 months; limited English language skills which might hinder their understanding of the Tai Chi instructions; requirement for supplemental oxygen during testing or training procedures.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The effects of the eight-week supervised Tai Chi training program will be determined by calculating the mean differences within the group for all outcomes from baseline to the eight-week time point using a paired t-test. Uncertainty about the size of the mean differences within groups will be quantified with 95% confidence intervals. The effects of the six-month home-based unsupervised maintenance Tai Chi training program will be determined by calculating the mean differences within the group for all outcomes from the eight-week time point to the three- and six-month time points respectively using a paired t-test to identify whether any improvements have been sustained. The three- and six-month time points will also be compared to baseline using a paired t-test to determine if the combination of the supervised and unsupervised Tai Chi program resulted in improvements being better than baseline for all outcome measures.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
26/05/2016
Date of last participant enrolment
Anticipated
Actual
7/03/2017
Date of last data collection
Anticipated
Actual
29/12/2017
Sample size
Target
48
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6437 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 6438 0
Mona Vale Hospital - Mona Vale
Recruitment postcode(s) [1] 13997 0
2139 - Concord
Recruitment postcode(s) [2] 13998 0
2103 - Mona Vale

Funding & Sponsors
Funding source category [1] 294264 0
University
Name [1] 294264 0
The University of Sydney
Country [1] 294264 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney, NSW 2006
Country
Australia
Secondary sponsor category [1] 293100 0
None
Name [1] 293100 0
Address [1] 293100 0
Country [1] 293100 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295693 0
Sydney Local Health District Human Research Ethics Committee – Concord Repatriation General Hospital
Ethics committee address [1] 295693 0
Ethics committee country [1] 295693 0
Australia
Date submitted for ethics approval [1] 295693 0
01/03/2016
Approval date [1] 295693 0
01/04/2016
Ethics approval number [1] 295693 0
HREC/16/CRGH/18

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1010 1010 0 0
/AnzctrAttachments/371273-HREC16CRGH18_Study_protocol.pdf
Attachments [2] 1011 1011 0 0
/AnzctrAttachments/371273-HREC16CRGH18_Participant_information_sheet.pdf

Contacts
Principal investigator
Name 68150 0
Dr Zoe McKeough
Address 68150 0
Rm 0203, O Block
Cumberland Campus C42
75 East St
The University of Sydney
Lidcombe NSW Australia 2141
Country 68150 0
Australia
Phone 68150 0
+61 2 9351 9269
Fax 68150 0
+61 2 9351 9278
Email 68150 0
[email protected]
Contact person for public queries
Name 68151 0
Zoe McKeough
Address 68151 0
Rm 0203, O Block
Cumberland Campus C42
75 East St
The University of Sydney
Lidcombe NSW Australia 2141
Country 68151 0
Australia
Phone 68151 0
+61 2 9351 9269
Fax 68151 0
+61 2 9351 9278
Email 68151 0
[email protected]
Contact person for scientific queries
Name 68152 0
Zoe McKeough
Address 68152 0
Rm 0203, O Block
Cumberland Campus C42
75 East St
The University of Sydney
Lidcombe NSW Australia 2141
Country 68152 0
Australia
Phone 68152 0
+61 2 9351 9269
Fax 68152 0
+61 2 9351 9278
Email 68152 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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