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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]

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

Condition category

Condition code

Respiratory

Chronic obstructive pulmonary disease

Physical Medicine / Rehabilitation

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]

Rehabilitation

Intervention code [2]

Behaviour

Intervention code [3]

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]

Exercise capacity measured by change in six minute walk distance

Timepoint [1]

Baseline
8 weeks post commencement of the intervention
6 months post end-rehabilitation

Secondary outcome [1]

Change in health related quality of life measured by Chronic Respiratory Disease Questionnaire domains of dyspnoea, fatigue, emotional function and mastery

Timepoint [1]

Baseline
8 weeks post commencement of the intervention
6 months post end-rehabilitation

Secondary outcome [2]

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]

Baseline
8 weeks post commencement of the intervention
6 months post end-rehabilitation

Secondary outcome [3]

Change in dyspnoea measured by the Modified Medical Research Council Scale

Timepoint [3]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/06/2015

Date of last participant enrolment

Anticipated

31/10/2016

Actual

15/03/2017

Date of last data collection

Anticipated

15/11/2017

Actual

22/11/2017

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred - Prahran

Recruitment hospital [2]

Austin Health - Austin Hospital - Heidelberg

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Institution for Breathing and Sleep - The Austin Hospital

Address [1]

Bowen Centre, Austin Hospital
145 Studley Road
Heidelberg
Victoria, 3084

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

The Eirene Lucas Foundation

Address [2]

Queen Street 31
3000 Melbourne
Victoria - Australia

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Alfred Hospital Ethics Committee

Ethics committee address [1]

 Office of ethics and research governance
Ground floor, The Alfred 
55 Commercial Road
Melbourne VIC 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/11/2014

Approval date [1]

09/01/2015

Ethics approval number [1]

101/15

Ethics committee name [2]

The Austin Human Research Ethics Committee

Ethics committee address [2]

Research Ethics
Office for Research
Level 8, Harold Stokes Building 
Austin Health
PO Box 5555
Heidelberg
Victoria
Australia 3084

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

14/11/2014

Approval date [2]

16/03/2015

Ethics approval number [2]

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

Prof Anne Holland

Address

La Trobe Clinical School
Level 4, The Alfred Centre
99 Commercial Road
MELBOURNE VIC 3004

Country

Australia

Phone

+61 419 379 821

Fax

+61395332104

[email protected]

Contact person for public queries

Name

Aroub Lahham

Address

La Trobe Clinical School
Level 4, The Alfred Centre
99 Commercial Road
MELBOURNE VIC 3004

Country

Australia

Phone

+61 423 033 038

Fax

+61395332104

[email protected]

Contact person for scientific queries

Name

Anne Holland

Address

La Trobe Clinical School
Level 4, The Alfred Centre
99 Commercial Road
MELBOURNE VIC 3004

Country

Australia

Phone

+61 419 379 821

Fax

+61395332104

[email protected]

No information has been provided regarding IPD availability

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

Source	Title	Year of Publication	DOI
Embase	The impact of home-based pulmonary rehabilitation on people with mild chronic obstructive pulmonary disease: A randomised controlled trial.	2020	https://dx.doi.org/10.1111/crj.13138

N.B. These documents automatically identified may not have been verified by the study sponsor.

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