Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000529448
Ethics application status
Approved
Date submitted
12/05/2025
Date registered
26/05/2025
Date last updated
26/05/2025
Date data sharing statement initially provided
26/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Integrating Kapa Haka and pulmonary rehabilitation for Maori with chronic airways disease
Scientific title
Efficacy of integrating Kapa Haka and pulmonary rehabilitation on uptake and wellbeing in Maori with chronic airways disease - a pilot study
Secondary ID [1] 314095 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 337445 0
Bronchiectasis 337446 0
Asthma 337447 0
Condition category
Condition code
Respiratory 333817 333817 0 0
Chronic obstructive pulmonary disease
Respiratory 333818 333818 0 0
Asthma
Respiratory 333819 333819 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a pilot study integrating Kapa Haka and Pulmonary Rehabilitation for Maori with chronic airways disease

Setting:
- Marae
- Available twice weekly, capacity for 30 people, facilities such as rest-rooms, chairs, heating, power defibrillator (AED).
- Transport will be provided for participants if needed

Intervention: Integrated Kapa Haka/pulmonary rehabilitation programme
- Run over 8 weeks, twice per week (16 sessions in total)
- 2 hour sessions run on Tuesdays and Thursdays 9.30 - 11.30am
- 15 participants in total; all participants will take part in the same session.
- Led by 2x Kapa Haka experts and 1x pulmonary rehabilitation physiotherapist

- Week 1:
- Session 1: Whakawhanaungatanga session:
- Mihimihi
- Demographic and health information collection
- Assessing preferences for education sessions
- Session 2: Testing session:
- 2x six minute walk test
- 5 x sit to stand test
- BMI
- Questionnaires: CRD-Q, Hua Oranga, CAT

- Weeks 2-8: Combined Kapa Haka and pulmonary rehabilitation sessions
- Comprising endurance (aerobic) and strength (upper and lower body) exercises (90mins) as per pulmonary rehabilitation essential criteria, which will include:
- Karakia timatanga (opening prayer)
- Waiata (an example of endurance exercise)
- Poi (an example of endurance exercise)
- Rakau
- Haka (an example of strength exercise)
- Karakia whakamutunga (closing)
- And education sessions (to be guided by participant preferences) (30mins), which will be delivered using Powerpoint slides combined with interactive group discussion, the topics of which may include:
- Disease (chronic airways disease) definition, cause, diagnosis, management, prognosis
- Management of chronic airways disease
- Inhalers, medications (antibiotics, prednisone)
- Monitoring symptoms and action plan
- Breathing and relaxation strategies
- Airway clearance strategies
- Goal setting, advanced care planning
- Lifestyle change
- Smoking cessation
- Nutrition
- Exercise
- Kapu ti (refreshments)
- Note sessions will aim to meet criteria as set out in the Official American Thoracic Society Workshop Report on Defining Modern Pulmonary
Rehabilitation (Holland et al, 2021) as much as practically possible, as designed by Delphi consensus
- Data on adverse events will be collected at the time of any events arising throughout the programme
- Attendance of each participant at each session will be recorded in a session attendance checklist

- Week 8 final session:
- 2x six minute walk test
- 5x sit to stand test
- Questionnaires: Hua Oranga, CAT, CRD-Q, sense of control, acceptability questionnaire, participant reported experience

Reimbursement:
- Transport (and/or parking costs) will be provided (or reimbursed) for participants who require it to and from the venue for each session.
- Additionally, a small koha will also be offered to each participant at each session for participating in the study.

Safety and Data Monitoring:
- There will always be medically trained people who have completed basic life support training (either on interventional team or on steering committee) and a defibrillator (AED) on site in the event of injury or a medical emergency.
- If quality of life questionnaires raise concerns about psychosocial distress, then this will be reported to the Principal Investigator who will assess the concerns and take action if needed e.g. referrals, and whether continued participation in the study is appropriate.
- If the data collection step incidentally finds any other health issues, these will be brought to the attention of the Principal Investigator for appropriate referral and follow up to be made
- Adverse events will be reported to the Primary Investigator, immediately assessed, acted on and recorded in the Adverse Events record and reported to the steering committee to determine whether there are ongoing safety concerns for individual or other participants.
- Any adverse event or result of clinical concern will be notified to the GP and/or referring health practitioner and this notification will not be optional.
- The study will be terminated if the frequency and severity of adverse events is such that the steering committee decides it unsafe to continue with the study.
Intervention code [1] 331042 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341428 0
Completion of Kapa Haka pulmonary rehabilitation pilot programme
Timepoint [1] 341428 0
At each session of the 8 week programme (twice per week)
Primary outcome [2] 341429 0
Safety of Kapa Haka pulmonary rehabilitation pilot programme
Timepoint [2] 341429 0
Record updated at each session of the 8 week programme
Secondary outcome [1] 447457 0
Participant Reported Experience and Sense of Control
Timepoint [1] 447457 0
8 weeks after commencement of study (ie at end of pilot programme)
Secondary outcome [2] 447459 0
Change in health-related quality of life scores
Timepoint [2] 447459 0
At baseline (week 1 of pilot programme) and at week 8 (end of programme)
Secondary outcome [3] 447460 0
Physical effect size of pilot Kapa Haka and pulmonary rehabilitation programme
Timepoint [3] 447460 0
At baseline and at 8 weeks (completion) of study
Secondary outcome [4] 447464 0
Patient perceived benefit of pilot programme
Timepoint [4] 447464 0
8 weeks after commencement of study (ie at end of pilot programme)
Secondary outcome [5] 447833 0
Change in health-related quality of life score
Timepoint [5] 447833 0
At baseline (week 1 of pilot programme) and at week 8 (end of programme)
Secondary outcome [6] 447834 0
Change in health-related quality of life score
Timepoint [6] 447834 0
At baseline (week 1 of pilot study) and at completion (week 8)
Secondary outcome [7] 447835 0
Physical effect size of pilot Kapa Haka and pulmonary rehabilitation programme
Timepoint [7] 447835 0
At baseline (week 1 of pilot study) and at completion (week 8)

Eligibility
Key inclusion criteria
- Signed written informed consent to participate
- Chronic airways disease, including chronic obstructive airways disease (COPD), chronic asthma and bronchiectasis, as defined by GINA (2019), GOLD (2018), or Thoracic Society of Australia and New Zealand (TSANZ) (2015)
- Self-identified ethnicity as Maori
- Aged 16 years or older
- Preferential recruitment of participants who have not attended or completed pulmonary rehabilitation despite having been referred
- Reside within catchment areas for Auckland or Waitemata District Health Boards
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- An inability to provide written informed consent to participate.
- A requirement for supplementary oxygen for exercise
- Other medical condition that would make PR exercise unsafe e.g. unstable angina, severe aortic stenosis, myocardial infarction in last 4 weeks, any other medical condition or cognitive impairment which restricts the patient’s ability to participate in exercise.
- An inability to walk, or an inability to walk safely and independently is impaired due to non-respiratory comorbidity

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
15 participants was chosen as this is the standard number of patients in a typical pulmonary rehabilitation programme within Auckland and was the maximum number of participants felt feasible to conduct the programme

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/05/2025
Actual
Date of last participant enrolment
Anticipated
3/06/2025
Actual
Date of last data collection
Anticipated
24/07/2025
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 27061 0
New Zealand
State/province [1] 27061 0
Te Toka Tumai, Waitemata

Funding & Sponsors
Funding source category [1] 318603 0
Government body
Name [1] 318603 0
Te Whatu Ora Te Toka Tumai
Country [1] 318603 0
New Zealand
Primary sponsor type
Government body
Name
Te Whatu Ora Te Toka Tumai
Address
Country
New Zealand
Secondary sponsor category [1] 321425 0
None
Name [1] 321425 0
Address [1] 321425 0
Country [1] 321425 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317205 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 317205 0
Ethics committee country [1] 317205 0
New Zealand
Date submitted for ethics approval [1] 317205 0
16/04/2025
Approval date [1] 317205 0
02/05/2025
Ethics approval number [1] 317205 0
2025 EXP 11123

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140338 0
Dr Sandra Hotu
Address 140338 0
Auckland City Hospital, 2 Park Rd, Grafton, Auckland 1023
Country 140338 0
New Zealand
Phone 140338 0
+64 9 307 4949 25178
Fax 140338 0
Email 140338 0
[email protected]
Contact person for public queries
Name 140339 0
Oliver Armstrong-Scott
Address 140339 0
Auckland City Hospital, 2 Park Rd, Grafton, Auckland 1023
Country 140339 0
New Zealand
Phone 140339 0
+64 273193229
Fax 140339 0
Email 140339 0
[email protected]
Contact person for scientific queries
Name 140340 0
Oliver Armstrong-Scott
Address 140340 0
Auckland City Hospital, 2 Park Rd, Grafton, Auckland 1023
Country 140340 0
New Zealand
Phone 140340 0
+64 273193229
Fax 140340 0
Email 140340 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: As per the data management plan, data obtained from participants will be de-identified to maintain patient confidentiality.



What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24717Informed consent form    Participant Information and Consent Form.docx
24718Study protocol    Study Protocol for HDEC Review April 2025 version 2 - clean copy.docx
24719Ethical approval    HDEC Approval Letter attachmentEntry-56163.pdf



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.