ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620001237976p

Ethics application status

Submitted, not yet approved

Date submitted

13/08/2020

Date registered

18/11/2020

Date last updated

18/11/2020

Date data sharing statement initially provided

18/11/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Virtual models for delivery of exercise training in Cystic Fibrosis (CF): an evaluation of patient engagement and feasibility.

Scientific title

Virtual models for delivery of exercise training in CF: an evaluation of patient engagement and feasibility.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Cystic Fibrosis

Condition category

Condition code

Human Genetics and Inherited Disorders

Cystic fibrosis

Physical Medicine / Rehabilitation

Physiotherapy

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Pulmonary rehab is already a well-established treatment modality for patients with chronic respiratory disease. Traditionally, it has been offered in a face-to-face class environment however due to the risk of cross infection, this cannot occur in a CF population. While there is research supporting the benefits of a pulmonary rehabilitation program virtually, this has not been explored with this demographic of patients.

Subsequently, the aim of this study is to evaluate the feasibly and patient engagement with two models of interactive online exercise classes to deliver and promote exercise in adults with Cystic Fibrosis, and patient perceptions of this intervention.

Setup required for the program will require a computer, tablet or mobile device with internet connection. A pilates mat or weights may be required however it will be ensured all participants have access to these prior to commencing the study. The exercise classes in both models will be conducted by the CF physiotherapist. The level of intensity will be monitored by modifed BORG however all patients will be encouraged to self pace during the session based on their own exercise tolerance. The sessions will be 40minutes in length including the warm up and cool down for both exercise models. The duration of the intervention will be 8 weeks with sessions occurring 2x/wkly with a 3rd independent exercise session encouraged. The exercises prescribed to all participants will be standardised however they progressions will be provided for patients for them to choose based on their exercise capacity (eg. sit to stand OR squats OR jump squats). Adherence of the exercise session will be marked on attendance via role call for the traditional model of pulmonary rehab and questionaire for the independent exercise package.

The models of interactive exercise that will be used are a virtual exercise class that occurs in real time with 6 patients and 1 physiotherapist via telehealth. The second model of online exercise class will be an independent package where the patients recruited to this model will be provided with videos for exercise sessions that they will complete independently, un-supervised, in their own time

Intervention code [1]

Rehabilitation

Intervention code [2]

Treatment: Other

Comparator / control treatment

The control group will complete gold standard pulmonary rehab using a virtual model. This will involve telehealth via the Cisco Jabber platform which will allow patients to interact with the physiotherapist conducting the exercise class. As already outlined, the program will occur 2x/weekly with a 3rd independent exercise session encouraged. Progressions, modifications and feedback on technique will be provided to all participants.

Control group

Active

Outcomes

Primary outcome [1]

- Number of exercise sessions completed
Measured by role call of attendance or questionnaire completed by the patient regarding number of sessions they participated in.

The questionnaire has been developed specifically for this study using an online platform from the Metro North Consumer Engagement Platform.

Timepoint [1]

Immediately post completion of 8 week program

Primary outcome [2]

- Patient satisfaction

Patient satisfaction will be assessed using a Liekert scale on a questionnaire specifically designed for the study, as outlined above. Answers will be de-identfied (they are submitted anonymously) and analysed.

Timepoint [2]

Completion of the 8 week program

Primary outcome [3]

• Survey developed with local research and Metro North Engage Team.
Focus of feedback will be to assess demand, implementation (study and session completion), practicality (technical issues) and acceptability of training modes and the virtual platform (participant feedback).
• Combination of Likert scales and open-ended questions. Example questions may include: What was your most/least favourite part of the program and why? Would you participate in a similar program again? What type of changes have you seen because of the program, if any? How has the program helped you?

Timepoint [3]

Completion of the 8wk program

Secondary outcome [1]

Survey.
1. The health outcomes assessed are patient feedback and preference
2. The survey has been designed specifically for use in this study

Timepoint [1]

Immediately post 8wk completion of the pulmonary rehab program

Eligibility

Key inclusion criteria

- Patients >18 years of age serviced by the ACFC at The Prince Charles Hospital with a diagnosis of gene confirmed cystic fibrosis.
- RFT’s 30-70% predicted FEV1

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- Severe pulmonary disease (RFT’s <30% FEV1)
- Mild pulmonary disease (RFT’s >70% predicted FEV1 )
- Use of domiciliary oxygen therapy
- Unable to perform exercise as determined by the medical and/or physiotherapy team
- Death is deemed imminent or the patient is actively being palliated
- Patients/NOK on patients behalf do not consent 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)

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

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The key statistics are differences in patient engagement correlated with the model of virtual pulmonary rehab in which they are allocated. Data will undergo analysis and interpretation by the principal investigators and statistician using parametric/non-parametric statistics as appropriate. Between-group comparison of categorical data will be performed using Chi square or logistical regression and comparisons of the data will be made. Descriptive statistics will quantify all outcomes pre and post the exercise intervention. Pairwise comparisons will be made for all measures pre and post the exercise intervention. Results will be accepted as statistically significant at p< 0.05.

Descriptive analysis of the post quantitative questions will be performed. Responses to open ended questions will be coded and organised, and a thematic analysis will be conducted to identify themes about the feasibility and acceptability of the programs to the participants.

As this is a pilot, feasibility study, it is difficult to calculate an appropriate sample side required to effectively power it. Therefore, this proposal is using a convenience sample of 12 patients assigned to each virtual mode that are likely to be recruited during the study period.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

31/12/2020

Actual

Date of last participant enrolment

Anticipated

30/04/2021

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

The Prince Charles Hospital - Chermside

Recruitment postcode(s) [1]

4032 - Chermside

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Physiotherapy Department The Prince Charles Hospital

Address [1]

The Prince Charles Hospital
627 Rode Road
Chermside, 4032
QLD

Country [1]

Australia

Primary sponsor type

Hospital

Name

The Prince Charles Hospital

Address

The Prince Charles Hospital
627 Rode Road
Chermside, 4032
QLD

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]

The Prince Charles Hospital Human Research Ethics Committee

Ethics committee address [1]

The Prince Charles Hospital
627 Rode Road
Chermside, 4032 QLD

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/08/2020

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Physical activity is recognised as an essential component of maintenance of respiratory health in cystic fibrosis (CF), and delivery of exercise education is a critical component of physiotherapy care. Reduced exercise capacity is associated with a decline in respiratory function and survival in people with CF. In both short and long-term studies, regular exercise has been demonstrated to decrease the annual decline in lung function in people with CF. Continued innovative approaches to prompt both exercise and activity participation and adherence at home for adults with cystic fibrosis is required.  Group based exercise training is established as the gold standard in people with COPD resulting in reduced symptoms, improved quality of life outcomes, increased exercise capacity, reduced exacerbations and the prevention of hospital exacerbations. The current COVID-19 pandemic has already prompted a shift to ‘virtual’ models of care delivery within CF centres. People with CF are currently, and for the foreseeable future, receiving decreased routine face to face outpatient appointments at hospitals.  This current change to care delivery minimises opportunities to offer exercise training for this cohort of patients. 

Home based tele-rehabilitation group exercise programs have been shown to improve exercise capacity in patients with COPD and other chronic diseases.  A systematic review of telehealth in cystic fibrosis highlighted the potential to provide both physical activity and exercise programmes. Exercise sessions of 30 minutes, three times a week over six weeks offered via a virtual platform to children with CF demonstrated participation rates of 85%.  The program was found to be a convenient and accessible method of encouraging physical activity and participants reported positive feedback regarding joining a group supervised class. Tomlenson et al ( 2019) examined the feasibility and acceptability of online exercise sessions using telehealth in nine adults  with CF to engage patients in individualised exercise programs 2 -3 times a week 20.  The participants successfully participated in the classes, rating satisfaction with the virtual training at 9/10, while compliance with sessions was 68%. Whilst these studies suggest that online training is feasible, questions remain regarding the applicability of the outcomes to the cohort of patients provided with care by TPCH Adult Cystic Fibrosis centre (ACFC). The large number of patients receiving care by this centre (over 300) is prohibitive to offering all patients individualised exercise classes. 

Delivery of 1-on-1 exercise training is labour intensive and expensive. Rapid improvements in survival of people with CF is expected to result in increased demand on physiotherapy services, which will outstrip service capacity. Consequently, alternate, scalable models of delivering exercise training are required.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Miss Kelly Burgess

Address

The Prince Charles Hospital
627 Rode Road
Chermside, QLD 4032

Country

Australia

Phone

+61 7 3139 6272

Fax

kelly.burgess@health.qld.gov.au

Contact person for public queries

Name

Kelly Burgess

Address

The Prince Charles Hospital
627 Rode Road
Chermside, QLD 4032

Country

Australia

Phone

+61 7 3139 6272

Fax

kelly.burgess@health.qld.gov.au

Contact person for scientific queries

Name

Kelly Burgess

Address

The Prince Charles Hospital
627 Rode Road
Chermside, QLD 4032

Country

Australia

Phone

+61 7 31396272

Fax

kelly.burgess@health.qld.gov.au

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
8760	Study protocol					380363-(Uploaded-13-08-2020-02-17-15)-Study-related document.docx
8762	Informed consent form					380363-(Uploaded-13-08-2020-03-09-38)-Study-related document.docx

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.

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