Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000505404
Ethics application status
Approved
Date submitted
11/03/2016
Date registered
19/04/2016
Date last updated
16/11/2018
Date data sharing statement initially provided
16/11/2018
Date results provided
16/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
When is the optimal time to implement pulmonary rehabilitation for people with Chronic Obstructive Pulmonary Disease (COPD)?
Scientific title
When is the optimal time to implement pulmonary rehabilitation for people with Chronic Obstructive (COPD), for best uptake and attendance by patients?
Secondary ID [1] 288729 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 297970 0
Condition category
Condition code
Physical Medicine / Rehabilitation 298129 298129 0 0
Other physical medicine / rehabilitation
Respiratory 298366 298366 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly allocated into three groups with participants commencing pulmonary rehabilitation at these various time frames (during hospital admission, 4 weeks post hospital discharge and 8 weeks post hospital discharge). This rehabilitation program consists of a total of 16 hours of exercise training and 8 hours of education. The exercise training component includes endurance (walking and cycling program) and upper and lower limbs muscle strength training. Participants are required to exercise at 80% of maximal intensity during the rehabilitation program and will complete training for one hour (approximately 30 minutes of walking/cycling and 30 minutes of strength training (two upper and lower limb exercises using free weights), twice a week. This exercise intensity will correlate to a participant exercising at a level of perceived dyspnea between 3 and 5 on the Borg scale (from 0 for no breathlessness to 10 for the most severe breathlessness) and a Borg exertion score of less than 13 for perceived level of exertion (from 6 for no exertion at all to 20 for maximal exertion) during the exercise training. The exercise training will be delivered by a qualified physiotherapist via small group sessions at the outpatient physiotherapy department at either sites. As for the education component, participants will attend an hour of group education each week with topics delivered by a multi-disciplinary team. Individual health professional in the multi-disciplinary team will be responsible for delivering a topic relevant to the management of COPD each week. The list of topics include exercise principles for people with COPD, relaxation techniques, use of bronchodilators, continence management, managing dyspnea and anxiety. These sessions will take place on the same day after the completion of an exercise training so as to reduce the number of visits a participant is required to make during the rehabilitation program. The only variation to the intervention will occur in the group which commences pulmonary rehabilitation at time of hospital admission. Due to the acuity of their exacerbation of COPD, participants in this group will complete 4 1/2 hour exercise sessions which includes both 15 minutes strength (both upper and lower limb) and 15 minutes endurance training (10 minutes of walking and 5 minutes of cycling) once a week until they are discharged from hospital. Pulmonary rehabilitation will be implemented within 4 days of admission. Upon discharge, they will continue their rehabilitation as per normal protocol. A register of attendance will be use to capture the attendance at each session. In a occasion that a participant has failed to turn up for his rehabilitation session, a follow up phone call will be made by a member of the research team to offer the participant an opportunity to make up for their missed session. Each participant will be offered three opportunities to make up for their missed session.
Intervention code [1] 294168 0
Rehabilitation
Comparator / control treatment
Participants who have been randomly allocated to the control group will have to complete a 8 week pulmonary rehabilitation program that commences at 8 weeks post hospital discharge. The rehabilitation program will be identical to the intervention group. The assessment will include number of attended sessions, 6 minute walk test distances, quadriceps muscle strength, number of respiratory related hospital admission within 6 months post initial hospital discharge and mortality rates.
Control group
Active

Outcomes
Primary outcome [1] 297634 0
Completion rates of pulmonary rehabilitation. This outcome will be assessed by number of participants who had completed at least 80% of total possible exercise sessions through review of rehabilitation attendance registers.
Timepoint [1] 297634 0
12 weeks post commencement of rehabilitation program
Primary outcome [2] 297635 0
Proportion of participants who had attended their first scheduled session. This outcome will be assessed by review of attendance registers in this trial.
Timepoint [2] 297635 0
Time of scheduled commencement of rehabilitation program
Secondary outcome [1] 321652 0
Physical function, assessed by 6 minute walk test distances
Timepoint [1] 321652 0
At 4 weeks, 8 weeks and 6 months post hospital discharge
Secondary outcome [2] 321653 0
Quadriceps muscle strength as assessed by hand held dynamometer.
Timepoint [2] 321653 0
At hospital discharge, 4 weeks,8 weeks and 6 months post hospital discharge
Secondary outcome [3] 321654 0
Number of respiratory-related hospital admissions assessed by the number of hospital admissions reported by participants and data linkage to hospital records.
Timepoint [3] 321654 0
6 months post hospital discharge
Secondary outcome [4] 321655 0
Mortality rates
Timepoint [4] 321655 0
6 months post hospital discharge

Eligibility
Key inclusion criteria
Patients will be eligible for recruitment if they are: i) admitted into hospital with a primary diagnosis of an acute or infective exacerbation of COPD; ii) aged 40 years and above; iii) able to ambulate independently with or without a gait aid or oxygen; iv) deemed medically stable by the treating team to commence participation of pulmonary rehabilitation during hospital admission; v) have no significant comorbidities that will affect the patient’s ability to participate in rehabilitation and vi) are willing to participate in an 8-week pulmonary rehabilitation program.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential patients who required a direct admission to the intensive care unit for treatment of type II respiratory failure and patients who are housebound prior to hospital admission will be excluded from the trial. In addition, patients who have completed pulmonary rehabilitation in the 6 months prior to hospital admission will be excluded.

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)
Randomisation will be completed using a computerised random number generator. Group allocation will be concealed in an opaque, sealed envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be performed by an individual who is independent of the research team using a computerised random number generator, using permute blocks and stratified for site.
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
An estimated 69 participants will need to be recruited for this trial using the assumptions that the median sample size for each group in previous trials investigating effects of early commencement of pulmonary rehabilitation is 20 participants and the expected attrition rate for this population is estimated at 15%. Both an intention to treat and a per-protocol analysis will be completed for this trial. The number of sessions attended by participants will be expressed as a percentage over the total number of sessions. The percentage differences in attendance and completion rates in each group will be compared using one-way ANOVA. Reasons for missing rehabilitation sessions will be descriptively analysed. Number of respiratory-related hospital readmissions over the 6 months post hospital discharge will be reported as an incident rate ratio using a negative binomial regression model. Binary logistic regression will be used to calculate mortality odd ratios and compared between groups. Changes in 6-minute walk test and quadriceps strength will be analysed using ANCOVA using the baseline results as a covariate. An estimated of effect sizes (standardised mean differences) will also be calculated.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/05/2016
Actual
2/05/2016
Date of last participant enrolment
Anticipated
28/04/2017
Actual
25/10/2017
Date of last data collection
Anticipated
6/05/2018
Actual
1/06/2018
Sample size
Target
69
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5424 0
Sunshine Hospital - St Albans
Recruitment hospital [2] 5425 0
Western Hospital - Footscray
Recruitment postcode(s) [1] 12908 0
3021 - St Albans
Recruitment postcode(s) [2] 12909 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 293090 0
Hospital
Name [1] 293090 0
Office for research- Western Health
Country [1] 293090 0
Australia
Primary sponsor type
Individual
Name
Clarice Tang
Address
Department of Physiotherapy
Sunshine Hospital
Furlong Road
St Albans
Vic 3021
Australia
Country
Australia
Secondary sponsor category [1] 291874 0
Individual
Name [1] 291874 0
Anne Marie Southcott
Address [1] 291874 0
Respiratory and sleep medicine department
Footscray Hospital
Gordon Street
Footscray
Vic 3011
Australia
Country [1] 291874 0
Australia
Secondary sponsor category [2] 291875 0
Individual
Name [2] 291875 0
Elizabeth Skinner
Address [2] 291875 0
Department of Physiotherapy
Sunshine Hospital
176 Furlong Road
St Albans
Vic 3021
Australia
Country [2] 291875 0
Australia
Secondary sponsor category [3] 291876 0
Individual
Name [3] 291876 0
Kathryn Barker
Address [3] 291876 0
Department of Physiotherapy
Sunshine Hospital
Furlong Road
St Albans
Vic 3021
Country [3] 291876 0
Australia
Secondary sponsor category [4] 291877 0
Individual
Name [4] 291877 0
Felicity Blackstock
Address [4] 291877 0
Western Sydney University
Building 24.2.116
Campbelltown Campus
Locked Bag 1797, Penrith, NSW 2751, Australia
Country [4] 291877 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294597 0
Western Health Low Risk Ethics Panel (LREP)
Ethics committee address [1] 294597 0
Ethics committee country [1] 294597 0
Australia
Date submitted for ethics approval [1] 294597 0
28/01/2016
Approval date [1] 294597 0
10/03/2016
Ethics approval number [1] 294597 0
HREC/16/WH/11

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

Contacts
Principal investigator
Name 64294 0
Dr Clarice Tang
Address 64294 0
Department of Physiotherapy
Sunshine Hospital
Furlong Road
St Albans
Vic 3021
Country 64294 0
Australia
Phone 64294 0
+61411868030
Fax 64294 0
Email 64294 0
[email protected]
Contact person for public queries
Name 64295 0
Clarice Tang
Address 64295 0
Department of Physiotherapy
Sunshine Hospital
Furlong Road
St Albans
Vic 3021
Country 64295 0
Australia
Phone 64295 0
+61411868030
Fax 64295 0
Email 64295 0
[email protected]
Contact person for scientific queries
Name 64296 0
Clarice Tang
Address 64296 0
Department of Physiotherapy
Sunshine Hospital
Furlong Road
St Albans
Vic 3021
Country 64296 0
Australia
Phone 64296 0
+61411868030
Fax 64296 0
Email 64296 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data of individual participant will not be disclosed as per ethics submission. The results will be presented as a group rather than individual data.


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
No additional documents have been identified.