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Trial registered on ANZCTR


Registration number
ACTRN12616000360415
Ethics application status
Approved
Date submitted
14/03/2016
Date registered
21/03/2016
Date last updated
7/01/2020
Date data sharing statement initially provided
13/05/2019
Date results information initially provided
13/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
REAcH: Rehabilitation Exercise At Home. A trial of telerehabilitation for chronic respiratory disease.
Scientific title
REAcH: Rehabilitation Exercise At Home. A trial of telerehabilitation for chronic respiratory disease.
Secondary ID [1] 288625 0
None
Universal Trial Number (UTN)
Trial acronym
REACH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 297782 0
Bronchiectasis 303944 0
Asthma 303945 0
Interstitial Lung Disease 303946 0
Condition category
Condition code
Respiratory 297965 297965 0 0
Chronic obstructive pulmonary disease
Physical Medicine / Rehabilitation 298230 298230 0 0
Other physical medicine / rehabilitation
Respiratory 303301 303301 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this project is to determine whether pulmonary rehabilitation undertaken at home, delivered using internet-based technology to enable participant interaction and provide supervision of exercise, is at least as effective as hospital-based pulmonary rehabilitation in improving health-related quality of life, breathlessness and exercise capacity in people with chronic respiratory disease. People who agree to take part in the study will be randomly allocated to undertake pulmonary rehabilitation at either a hospital-based group or in their home, with internet-based supervision.
Remotely supervised telerehabilitation at home will be conducted twice a week for 8 weeks, in groups of 4-6 participants at a time. Participants will be able to see and talk to each other and be monitored continuously by the supervising physiotherapist. The home-based training program will consist of stationary cycling and light weights for the arms and legs. Resistance training will utilise functional activities such as sit to stand from a chair and upper limb weights. Exercise training will be prescribed to achieve 30 minutes of endurance training in each session. Participants will be encouraged to perform an additional 3 unsupervised sessions each week, which will be documented in a home diary that is reviewed weekly. Exercise will be progressed according to a standardised protocol. Prior to commencing exercise training, participants in the home-based group will receive a visit from a physiotherapist to ensure safe use of equipment. All equipment required to undertake telerehabilitation will be supplied by the study investigators for the duration of the rehabilitation period.
Intervention code [1] 294028 0
Treatment: Other
Intervention code [2] 294029 0
Rehabilitation
Intervention code [3] 294030 0
Lifestyle
Comparator / control treatment
Traditional centre-based pulmonary rehabilitation. Participants in the control group will undergo a standard outpatient pulmonary rehabilitation program. Directly supervised, centre-based pulmonary rehabilitation will be conducted twice a week for 8 weeks in groups of 8-12 participants. Participants in the group will be able to interact with each other and will be monitored continuously by the supervising physiotherapist. Centre-based pulmonary rehabilitation will consist of stationary cycling, walking (treadmill or corridor) and light weights for the arms and legs. Exercise will be progressed according to a standardised protocol. Resistance training will utilise functional activities such as sit to stand from a chair and upper limb weights. Exercise training will be prescribed to achieve 30 minutes of endurance training in each session. Participants will be encouraged to perform an additional 3 unsupervised sessions each week, which will be documented in a home diary that is reviewed weekly. Exercise training will be standardised across all centre-based pulmonary rehabilitation sites with the use of a protocol for prescription and progression.
Control group
Active

Outcomes
Primary outcome [1] 297488 0
Change in Chronic Respiratory Disease Questionnaire (CRQ) – Dyspnoea domain
Timepoint [1] 297488 0
Baseline to immediately following rehabilitation (‘end-rehab’). Assessment will occur on two occasions, once each at baseline and again at the end of the 8-week rehabilitation program.
Secondary outcome [1] 321181 0
Proportion of participants who complete the program (completion is considered to be completion of greater than or equal to 70% of sessions).
Timepoint [1] 321181 0
End-rehab
Secondary outcome [2] 321182 0
Change in 6-minute walk distance
Timepoint [2] 321182 0
Baseline
End-rehab
12-months
Secondary outcome [3] 321183 0
Change in endurance time during a constant work rate exercise test, performed at 75% of the peak work rate on a baseline incremental cardiopulmonary exercise test (CPET).
Timepoint [3] 321183 0
Baseline
End-rehab
12-months
Secondary outcome [4] 321184 0
Change in health-related quality of life will be measured using two instruments:
- CRQ domains of fatigue, mastery and emotional function; and,
- SF-36v2 (to derive a preference-based measure of HRQoL), and the SF-6D (for economic analyses)
Timepoint [4] 321184 0
Baseline
End-rehab
12-months
Secondary outcome [5] 321185 0
Change in self efficacy will be measured using the Pulmonary Rehabilitation Adapted Index of Self Efficacy (PRAISE) tool
Timepoint [5] 321185 0
Baseline
End-rehab
12-months
Secondary outcome [6] 321187 0
Change in Chronic Respiratory Disease Questionnaire (CRQ) – Dyspnoea domain
Timepoint [6] 321187 0
12-months
Secondary outcome [7] 321188 0
Change in Hospital Anxiety and Depression Scale
Timepoint [7] 321188 0
Baseline
End-rehab
12-months
Secondary outcome [8] 321189 0
Change in physical activity participation - objectively measured via accelerometery
Timepoint [8] 321189 0
Baseline
End-rehab
12-months
Secondary outcome [9] 321190 0
Change in perception of health status using the Modified Medical Research Council Dyspnoea Scale (mMRC).
Timepoint [9] 321190 0
Baseline
End-rehab
12-months

Eligibility
Key inclusion criteria
Key inclusion criteria are now:
- Individual with a primary chronic lung disease
- Aged greater than or equal to 40 years
- Able to read and speak English
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Primary diagnosis of pulmonary hypertension or lung cancer
- Attended pulmonary rehabilitation within the last 18 months UNLESS hospitalised for a respiratory cause in that time.
- Unstable or brittle asthma with a hospital or emergency department admission within the last 3 months
- Comorbidities that preclude exercise training
- Inability to follow verbal instructions; cognitive impairment; or language difficulties that would preclude safe participation in pulmonary rehabilitation program

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated, permuted block randomisation with stratification for:
i) recruitment post hospitalisation for acute exacerbation versus stable state
ii) site of recruitment
iii) diagnosis of ILD or not
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Continuous variables will be analysed by fitting linear mixed models, controlling for recruitment centre and baseline values as required. The relative risk of non-completion will be determined. All data will be analysed by intention to treat. An additional per-protocol analysis will also be conducted to reduce the risk of Type 1 error, as recommended in the CONSORT Extension for reporting of non-inferiority and equivalence trials. Alpha will be set at 0.05. Expert biostatistical oversight will be provided by one of the associate investigators.

If there is truly no difference in the change in the dyspnoea domain of the CRQ at the end of 8 weeks of telerehabilitation or traditional pulmonary rehabilitation, then 128 participants are required (64 in each group) to be 80% sure that the 95% confidence interval will exclude a difference in means of more than 2.5 points. This is the MID for the dyspnoea domain of the CRQ (Jaeschke et al 1989) and assumes a standard deviation of the change in CRQ dyspnoea of 4.8 points (Holland et al 2004). In our previous trials we saw 10% attrition at end of rehabilitation; we will therefore randomise a total of 142 participants.

This sample size will also give sufficient power for secondary outcomes:
* 6-min walk distance: If there is truly no difference in 6MWD at the completion of 8-weeks centre-based pulmonary rehabilitation or telerehabilitation, a total of 108 participants will be required. This sample size was determined by the 95% confidence interval excluding a difference in means between the two groups for 6MWD of more than 30 metres (Holland et al 2014), assuming a standard deviation of change in 6MWD of 53 metres (Holland et al 2010).
* Endurance Time: If there is truly no difference between in the change in constant work rate endurance time on cycle ergometer, then 52 participants are required to be 80% sure that the 95% confidence interval will exclude a difference in means of more than 150 seconds. This is the MID for endurance time for patients with COPD (Laviolette 2008) and assumes a standard deviation of 184 seconds (Laviolette 2008).
* Completion: Data from our centres indicate that only 65% people who are referred to pulmonary rehabilitation take up the referral and complete the program. Previous studies have documented completion rates for telerehabilitation programs of over 90% (Dinesen et al 2012, Piotrowicz et al 2010). Using a conservative estimate of 85% completion, 128 patients will be required to detect a difference in completion rates between telerehabilitation and traditional pulmonary rehabilitation.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5347 0
The Alfred - Prahran
Recruitment hospital [2] 5348 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 5349 0
Wimmera Health Care Group - Horsham - Horsham
Recruitment hospital [4] 5350 0
West Wimmera Health Service - Nhill - Nhill
Recruitment hospital [5] 13734 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 26481 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 292984 0
Government body
Name [1] 292984 0
National Health & Medical Research Council
Address [1] 292984 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 292984 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University
Level 6, The Alfred Centre
99 Commercial Road
Melbourne Vic 3004
Country
Australia
Secondary sponsor category [1] 291961 0
None
Name [1] 291961 0
Address [1] 291961 0
Country [1] 291961 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294493 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 294493 0
OFFICE OF ETHICS & RESEARCH GOVERNANCE
Ground Floor, Linay Pavilion
The Alfred
55 Commercial Road
Melbourne Vic 3004
Ethics committee country [1] 294493 0
Australia
Date submitted for ethics approval [1] 294493 0
11/01/2016
Approval date [1] 294493 0
04/02/2016
Ethics approval number [1] 294493 0
HREC/15/Alfred/101; Alfred 26/16

Summary
Brief summary
Chronic lung diseases, including chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), bronchiectasis and asthma, are characterised by breathlessness, reduced exercise tolerance and impaired quality of life. ‘Flareups’ of chronic lung disease are common in people with this condition and often lead to admission to hospital and decline in lung function, imposing considerable burden on patients and the healthcare system. Pulmonary rehabilitation is known to be effective at improving exercise tolerance and function, and helping to prevent ‘flareups’ particularly for people with COPD. However, it is often difficult for people to access these group exercise training programs due to issues surrounding transport and lack of access to programs, particularly in regional areas of Australia. Advances in internet technology and accessibility have made it possible for people to receive specialist medical care and rehabilitation therapy directly to their home. By using readily available equipment such as an exercise bike and iPad it is possible for people with chronic lung disease to undertake a supervised pulmonary rehabilitation program in their own home. However, whether this kind of training is as effective as hospital-based pulmonary rehabilitation is unknown.

This project aims to determine whether pulmonary rehabilitation undertaken at home, using internet-based technology, is at least as effective as centre-based pulmonary rehabilitation in improving quality of life, breathlessness and exercise capacity in people with chronic lung disease. People who agree to take part in the study will be randomly allocated to undertake pulmonary rehabilitation at either a hospital-based group or in their home, with internet-based supervision.

At the beginning and end of the 8 weeks of the intervention phase, and at 12months post completion of pulmonary rehabilitation, participants will undergo measurements of health status and exercise capacity. Hospital medical records and GP records will be reviewed to determine the frequency of acute chest infection and to identify hospital admissions and treatment of acute infections. This will be tracked for 12 months for all participants.

It is hypothesized that:
1. Home-based telerehabilitation will provide clinically significant improvements in health-related quality of life, exercise capacity and symptoms which are equivalent to those seen in centre-based rehabilitation.
2. Telerehabilitation, delivered using our low cost model, will be more cost-effective from a societal perspective when compared to centre-based pulmonary rehabilitation for chronic respiratory disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63902 0
Prof Anne Holland
Address 63902 0
Monash University
Level 6 The Alfred Centre
99 Commercial Road
Melbourne Vic 3004
Country 63902 0
Australia
Phone 63902 0
+61 3 9903 0214
Fax 63902 0
+61 3 9903 0556
Email 63902 0
anne.holland@monash.edu
Contact person for public queries
Name 63903 0
Dr Narelle Cox
Address 63903 0
Monash University
Level 6 The Alfred Centre
99 Commercial Road
Melbourne Vic 3004
Country 63903 0
Australia
Phone 63903 0
+61 3 9903 0134
Fax 63903 0
+61 3 9903 0556
Email 63903 0
narelle.cox@monash.edu
Contact person for scientific queries
Name 63904 0
Prof Anne Holland
Address 63904 0
Monash University
Level 6 The Alfred Centre
99 Commercial Road
Melbourne Vic 3004
Country 63904 0
Australia
Phone 63904 0
+61 3 9903 0214
Fax 63904 0
+61 3 9903 0556
Email 63904 0
anne.holland@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data can be shared once approval has been obtained from the relevant Human Research Ethics Committee.
When will data be available (start and end dates)?
Data will be available on a case by case basis, at the discretion of the Co-ordinating Principal Investigator and relevant Human Research Ethics Committee. Data will not be available prior to publication of the main trial results.
Available to whom?
Data will be available on a case by case basis, at the discretion of the Co-ordinating Principal Investigator and the relevant Human Research Ethics Committees.
Available for what types of analyses?
Type of analysis data will be available for will be at the discretion of the relevant Human Research Ethics Committee.
How or where can data be obtained?
Access to data will be subject to approval by the Co-ordinating Principal Investigator and approval by the relevant Human Research Ethics Committee.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 2074 0
Study protocol
Citation [1] 2074 0
Link [1] 2074 0
Email [1] 2074 0
Other [1] 2074 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary