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Trial registered on ANZCTR


Registration number
ACTRN12616000965404
Ethics application status
Approved
Date submitted
20/07/2016
Date registered
22/07/2016
Date last updated
12/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Early pulmonary rehabilitation in people with mild Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
Early pulmonary rehabilitation in people with mild Chronic Obstructive Pulmonary Disease (COPD)
Secondary ID [1] 289681 0
Nil Known
Universal Trial Number (UTN)
U1111-1185-5478
Trial acronym
EPR (Early Pulmonary Rehabilitation)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 299483 0
Condition category
Condition code
Respiratory 299462 299462 0 0
Chronic obstructive pulmonary disease
Physical Medicine / Rehabilitation 299466 299466 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Home-based pulmonary rehabilitation program (8 weeks): Participants are prescribed an exercise program by an experienced physiotherapist based on the results of their initial walking test. The exercise program consists of endurance (walking) and strengthening exercises. Participants are encouraged to exercise for 30 minutes, 5 times per week (including weekends). Strengthening exercises are performed using equipment that is available in the household (e.g. sit to stand from a chair, use of water bottles as arm weights). To optimise safety and a full understanding of the exercise program, an initial home visit from the physiotherapist is arranged before the program launch. The home visit talks one hour and 30 minutes on average. This home visit session facilitates exercise goal setting and demonstrates exercises. The physiotherapist helps participants to choose strengthening exercise provided by the Better Living for COPD handbook according to their physical abilities and equipment available in their household. The physiotherapist then prescribe the strengthening exercise types, sets and repetitions for the participant and record them using the exercise diary provided. Assessment and correction of inhaler use is also carried out during the home visit. Weekly phone calls is then undertaken by the physiotherapist to review the exercise diary, perform self-management training and promote exercise progression. Each weekly phone calls takes approximately 20 to 30 minutes. Disease specific self-management training and exercise progression is achieved using the principles of motivational interviewing. The aims of this training are to advance disease knowledge, promote problem solving and facilitate health behaviour change. A physiotherapist trained in the use of motivational interviewing is performing the telephone calls. Discussions of exercise goals settings, exercise tracking and recognition and treatment of acute exacerbation is provided in home exercise diaries which are kept over 8 weeks. Participants are encouraged to track their progress against their goals on a daily basis.
Home exercise diaries is delivered by the physiotherapist at the initial visit. Exercise diaries contains guidelines of identifying and managing moderate and severe exacerbation according to GOLD guidelines with an action plan, and contact details in case of emergencies. Following that, a goal setting sheet is provided to encourage goal setting at the start of every week with details about the time, location, and repetitions of exercises. A tracking sheet follows the goal setting sheet in order to help participants track their endurance and strengthening exercises daily.
Intervention code [1] 295304 0
Rehabilitation
Intervention code [2] 295307 0
Behaviour
Intervention code [3] 295308 0
Lifestyle
Comparator / control treatment
Usual care (8 week) comprise of an advice to exercise 5 times a week for 30 minutes each session. This advice is directed to them through the initial phone call with the physiotherapist. Participants also recieve weekly telephone calls form physiotherapists to discuss general health in order to control for attention. Each weekly phone calls takes approximately 10 to 20 minutes. Participants allocated to usual care do not receive any feedback regarding their exercise participation.
Control group
Active

Outcomes
Primary outcome [1] 298947 0
Exercise capacity measured by change in six minute walk distance
Timepoint [1] 298947 0
Baseline
8 weeks post commencement of the intervention
6 months post end-rehabilitation
Secondary outcome [1] 325732 0
Change in health related quality of life measured by Chronic Respiratory Disease Questionnaire domains of dyspnoea, fatigue, emotional function and mastery
Timepoint [1] 325732 0
Baseline
8 weeks post commencement of the intervention
6 months post end-rehabilitation
Secondary outcome [2] 325733 0
Change in physical activity variables measured objectively by the SenseWear Armband Accelerometer (SWA). The SWA is worn for 7 days each time point and posted back on the 8th day.
Timepoint [2] 325733 0
Baseline
8 weeks post commencement of the intervention
6 months post end-rehabilitation
Secondary outcome [3] 325734 0
Change in dyspnoea measured by the Modified Medical Research Council Scale
Timepoint [3] 325734 0
Baseline
8 weeks post commencement of the intervention
6 months post end-rehabilitation

Eligibility
Key inclusion criteria
1- Participants must be diagnosed with mild COPD (GOLD stage I), defined as FEV1/FVC < 0.7 and postbronchodilator FEV1 >= 80% predicted
2- Participants must be over 40 years old of age
3- Participants must have a smoking history of not less than 10 packet years (current or former smokers)
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1- Acute exacerbation or hospitalisations during the last month before recruiting
2- Having a primary diagnosis of any other respiratory related disease such as Asthma or Restrictive Lung Disease
3- Having comorbidities that prevents exercise participation

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 using computer-generated online software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation with stratification for site of recruitment.
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
The mean improvement in 6MWD following traditional pulmonary rehabilitation in people with moderate to severe COPD is 48 metres, which represents a clinically important improvement. We anticipate that improvements in people with mild COPD will be at least as large. Assuming that the standard deviation of the change in 6MWD in mild COPD is 64 metres, a power of 0.8 and two-sided alpha of 0.0527, 58 participants (29 in each group) will be required to detect a difference in the change in 6MWD of 48 metres. The study will not be powered to detect differences in physical activity, symptoms or quality of life, but will provide preliminary data on which larger studies could be powered in the future.

Results will be expressed as mean and standard deviation (m +/- SD) values unless specified. Normality will be assessed using visual inspection and the Shapiro-Wilk test. All analysis will be performed using the SPSS software (version 22). Differences between group outcomes will be evaluated using a two-way analysis of variance (ANOVA) for continuous outcomes. The Chi-squared test will be used to evaluate the difference in categorical outcomes. A p-value of less than 0.05 will be considered to be significant.

Recruitment
Recruitment status
Completed
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] 6170 0
The Alfred - Prahran
Recruitment hospital [2] 6171 0
Austin Health - Austin Hospital - Heidelberg

Funding & Sponsors
Funding source category [1] 294063 0
Hospital
Name [1] 294063 0
Institution for Breathing and Sleep - The Austin Hospital
Address [1] 294063 0
Bowen Centre, Austin Hospital
145 Studley Road
Heidelberg
Victoria, 3084
Country [1] 294063 0
Australia
Funding source category [2] 294067 0
Charities/Societies/Foundations
Name [2] 294067 0
The Eirene Lucas Foundation
Address [2] 294067 0
Queen Street 31
3000 Melbourne
Victoria - Australia
Country [2] 294067 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe Clinical School
Level4, the Alfred Centre
99 Commercial Road
Melbourne
VIC 3004
Country
Australia
Secondary sponsor category [1] 292891 0
None
Name [1] 292891 0
Address [1] 292891 0
Country [1] 292891 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295478 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 295478 0
Office of ethics and research governance
Ground floor, The Alfred
55 Commercial Road
Melbourne VIC 3004
Ethics committee country [1] 295478 0
Australia
Date submitted for ethics approval [1] 295478 0
11/11/2014
Approval date [1] 295478 0
09/01/2015
Ethics approval number [1] 295478 0
101/15
Ethics committee name [2] 295479 0
The Austin Human Research Ethics Committee
Ethics committee address [2] 295479 0
Research Ethics
Office for Research
Level 8, Harold Stokes Building
Austin Health
PO Box 5555
Heidelberg
Victoria
Australia 3084
Ethics committee country [2] 295479 0
Australia
Date submitted for ethics approval [2] 295479 0
14/11/2014
Approval date [2] 295479 0
16/03/2015
Ethics approval number [2] 295479 0
HREC/14/Austin/599

Summary
Brief summary
Chronic obstructive pulmonary disease (COPD) is characterised by chronic inflammation of the airways and obstruction to airflow in the lungs, resulting in dyspnoea, chronic cough, and sputum production. The GOLD guidelines define mild COPD as a post-bronchodilator forced expiratory volume in 1 second (FEV1) to forced vital capacity ratio less than 0.7 and an FEV1 greater than of equal to 80% predicted. With COPD being a progressive and irreversible disease, disease management in the earlier stages is of great importance in order to optimise long term outcomes. People with mild COPD already have dynamic hyperinflation, impaired gas exchange and increased dead space ventilation which are associated with exercise limitation and fatigue. Also, a reduction in physical activity levels develops early in COPD, even before patients are diagnosed with the disease. According to a study exploring physical inactivity in patients with COPD, people with mild COPD were found to have 13% reduction in step counts and 47% reduction in time spent in moderate physical activity compared to healthy subjects. This is significant because lower physical activity levels are associated with increased mortality and increased hospitalisation in people with COPD.
Pulmonary rehabilitation (PR) is an eight-week program involving exercise training, education and support. In our previous research, we developed a home-based model of PR for people with moderate to severe COPD. Our findings suggested promising results in improving physical activity levels and enhancing health related quality of life. People with even the mildest forms of COPD have been shown to have markedly reduced levels of physical activity. We believe that the benefits attained in our home based program for patients with more severe disease may also be achieved in people in the early-stages of COPD. As most individuals with early-stage COPD are managed in primary care (and many are still working), a home-based PR program may be more acceptable for this patient group.
We hypothesise that a. pulmonary rehabilitation will result in clinically important improvement in six minute walk distance in people with GOLD stage I COPD; b. PR will improve dyspnoea, quality of life, and physical activity in GOLD stage I COPD.
In this RCT we will recruit 58 people diagnosed with early stage, mild COPD according to the Global Initiative for Chronic Obstructive Lung Disease guidelines. Participants will be randomised to receive either usual care or home-based pulmonary rehabilitation program.
Clinical measures will be recorded at baseline, 8 weeks-time point and 6 months. Outcome measures will include exercise capacity using change in 6 minutes walk distance, physical activity levels objectively measured by the sense wear armband (SWA), health related quality of life measured by change in the Chronic Respiratory Questionnaire and change in dyspnoea measured by the Modified Research Council Scale.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67426 0
Prof Anne Holland
Address 67426 0
La Trobe Clinical School
Level 4, The Alfred Centre
99 Commercial Road
MELBOURNE VIC 3004

Country 67426 0
Australia
Phone 67426 0
+61 419 379 821
Fax 67426 0
+61395332104
Email 67426 0
a.holland@alfred.org.au
Contact person for public queries
Name 67427 0
Miss Aroub Lahham
Address 67427 0
La Trobe Clinical School
Level 4, The Alfred Centre
99 Commercial Road
MELBOURNE VIC 3004
Country 67427 0
Australia
Phone 67427 0
+61 423 033 038
Fax 67427 0
+61395332104
Email 67427 0
a.lahham@latrobe.edu.au
Contact person for scientific queries
Name 67428 0
Prof Anne Holland
Address 67428 0
La Trobe Clinical School
Level 4, The Alfred Centre
99 Commercial Road
MELBOURNE VIC 3004
Country 67428 0
Australia
Phone 67428 0
+61 419 379 821
Fax 67428 0
+61395332104
Email 67428 0
a.holland@alfred.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary