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Trial registered on ANZCTR

Registration number

ACTRN12616001586404

Ethics application status

Approved

Date submitted

12/11/2016

Date registered

16/11/2016

Date last updated

16/06/2021

Date data sharing statement initially provided

7/12/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Effect of a pulmonary rehabilitation program of 8 weeks duration compared to 12 weeks on exercise capacity in people with chronic obstructive pulmonary disease (PuRe Duration): A randomised controlled trial

Scientific title

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

U1111-1188-4919

Trial acronym

PuRe Duration

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

Physiotherapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Exercise training in a pulmonary rehabilitation program twice per week for 12 weeks. Programs are completed in an outpatient hospital setting and run by physiotherapists. Each training session will run for between 1 - 1.5 hours.

Exercise training will consist of overground or treadmill walking, lower limb cycling, lower limb strengthening exercises (including body weight exercises; squats, sit to stands and step-ups and fixed weight exercises; leg press and leg extension) and upper limb exercises (including arm ergometry, lat pull-downs, chest press/fly and arm exercises with free weights).

Initial exercise intensities will be standardised for each modality. Walking (overground or treadmill) will begin at 80% of peak walk speed determined by the six-minute walk test (6MWT) and progressed based on symptoms of dyspnoea and fatigue, with the aim of participants scoring a dyspnoea or fatigue score of at least 3-4 ('moderate' to 'somewhat severe') on the modified Borg dyspnoea 0-10 scale. Initial walking duration will be 10-15 minutes and progressed to 20-30 minutes between weeks 2-4.
Lower limb cycling intensity will commence at 60% peak work rate using an equation based on the results of the 6MWT and progressed to 70% peak work rate based on symptoms of dyspnoea and fatigue, with the aim of participants scoring a dyspnoea or fatigue score of at least 3-4 on the modified Borg dyspnoea 0-10 scale.
Arm ergometry will be performed for 10 minutes at a Borg score of 3-4 on the modified Borg dyspnoea 0-10 scale.

Body weight lower limb strengthening exercises (squats, sit to stands and step ups) and arm free weight exercises will commence in week 2 at a load that can be achieved for 8 -10 repetitions before local muscle exhaustion. Fixed weight strengthening exercises for the lower limbs and upper limbs (leg extension, leg press, lat pull downs and chest press/fly) will commence in week 3 at a load that can be achieved for 8 -10 repetitions before local muscle exhaustion. By week 4, all strengthening exercise (body weight, free weight and fixed weight exercises) will be completed 3 times (i.e 3 sets). Resistances will be increased once participants can achieve 3 sets of 10 repetitions in two or more consecutive training sessions.

Attendance will be monitored by the physiotherapists and participants will be encouraged to attend each allocated session.

Intervention code [1]

Rehabilitation

Comparator / control treatment

Exercise training in a pulmonary rehabilitation program twice per week for eight weeks. Programs are completed in an outpatient hospital setting and run by physiotherapists. Each training session will run for between 1 - 1.5 hours.

The exercise training component will be the same as the intervention group.

Attendence will be monitored by the physiotherpists and participants will be encouraged to attend each allocated session.

Control group

Active

Outcomes

Primary outcome [1]

Endurance Shuttle Walk Test (ESWT)

Timepoint [1]

Baseline, four weeks, eight weeks, 12 weeks, six months and 12 months.

Secondary outcome [1]

St George's Respiratory Questionnaire (SGRQ)

Timepoint [1]

Baseline, four weeks, eight weeks, 12 weeks, six months and 12 months.

Secondary outcome [2]

COPD Assessment Test (CAT)

Timepoint [2]

Baseline, four weeks, eight weeks, 12 weeks, six months and 12 months.

Secondary outcome [3]

Hospital Anxiety Depression Scale (HADS)

Timepoint [3]

Baseline, four weeks, eight weeks, 12 weeks, six months and 12 months.

Secondary outcome [4]

Physical Activity via Actigraph and ActivPAL

Timepoint [4]

Baseline, seven weeks, completion of pulmonary rehabilitation program (eight or 12 weeks respectively), six months and 12 months.
Physical activity monitors will be worn for 1 week at each timepoint.

Secondary outcome [5]

Hospital Admissions using health district medical records

Timepoint [5]

Six months and 12 months post completion of pulmonary rehabilitation program (eight or 12 weeks respectively)

Secondary outcome [6]

Exercise Adherence via number of pulmonary rehabilitation sessions attended during the pulmonary rehabiltaiton program

Timepoint [6]

At completion of pulmonary rehabilitation program (eight or 12 weeks respectively)

Secondary outcome [7]

Length of Stay using health district medical records

Timepoint [7]

Six and 12 months post completion of pulmonary rehabilitation program (eight or 12 weeks respectively)

Eligibility

Key inclusion criteria

a) have a medical diagnosis of COPD [forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) <0.7 and an FEV1 between 20% and 80% predicted normal].

b) Referred to pulmonary rehabilitation.

Minimum age

40 Years

Maximum age

85 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

a) morbidly obese (BMI > 35 [kg/m2]).

b) receiving long term oxygen therapy (LTOT).

c) co-morbidities; either musculoskeletal, cardiovascular or neurological which would adversely affect exercise performance.

d) have participated in a supervised exercise program within the last 12 months.

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)

Participants will be randomly allocated, following informed consent, into one of two groups: an eight week or 12 week pulmonary rehabilitation program. Computerised, stratification randomisation will be completed for each consenting participant by a person independent of the study.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Sequence generation will be determined using a computer-generated randomisation program with a minimisation algorithm, stratifying for centre, gender, FEV1% <50% predicted, six minute walk distance (6MWD) <350m, oxygen desaturation during 6MWT <90%, and recent exacerbation of COPD (<4 weeks).

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size calculation was based for a significance level of 0.05 and a power of 0.8 with a standard deviation of the ESWT of 239 seconds (1). 58 participants are required to be 80% sure that the two-sided confidence interval will exclude a difference of the mean by 186 seconds (2,3). A total of 72 participants (36 per group) will be recruited to ensure that 58 participants will complete the study allowing for a 25% drop out rate that may be anticipated in the long term study.

Data will be analysed using SPSS, and expressed as means and standard deviations. Repeated measures ANOVA will analyse differences between the groups for all outcomes. Independent sample t-tests will assess the differences between groups at specific time points. Data will be analysed on an intention-to-treat (ITT) basis.

1. Leung RW, McKeough ZJ, Peters MJ, Alison JA. Short-form Sun-style t'ai chi as an exercise training modality in people with COPD. EurRespir J. 2013;41(5):1051-7.
2. Pepin V, Laviolette L, Brouillard C, Sewell L, Singh SJ, Revill SM, et al. Significance of changes in endurance shuttle walking performance. Thorax. 2011;66(2):115-20.
3. Holland AE, Spruit MA, Troosters T, et al. An official European Respiratory Society/American Thoracic Society Technical Standard: field walking tests in chronic respiratory disease. EurRespir J. 2014; 44: 1428-46.6.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

25/01/2017

Actual

27/02/2017

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)

NSW

Recruitment hospital [1]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [2]

Balmain Hospital - Balmain

Recruitment hospital [3]

Concord Repatriation Hospital - Concord

Recruitment postcode(s) [1]

2050 - Camperdown

Recruitment postcode(s) [2]

2041 - Balmain

Recruitment postcode(s) [3]

2139 - Concord

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Sydney Local Health District

Address [1]

Level 11, KGV Building
Missenden Road
CAMPERDOWN, NSW, 2050

Country [1]

Australia

Primary sponsor type

Individual

Name

Joshua Bishop

Address

Balmain Hospital
Physiotherapy Department
29 Booth Street
BALMAIN, NSW, 2041

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Research Ethics Committee (RPAH zone)

Ethics committee address [1]

Research Development Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN, NSW, 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/08/2016

Approval date [1]

21/09/2016

Ethics approval number [1]

Summary

Brief summary

Pulmonary rehabilitation (PR) guidelines and reviews of current research repeatedly state that PR programs should be between six and 12 weeks, with a recommended duration of eight weeks, but have been unable to draw significant conclusions regarding an optimal duration of PR programs to achieve improvements in exercise capacity and health-related quality of life.  

Aim : To evaluate the effect of an eight week pulmonary rehabilitation program compared to a 12 week program on exercise capacity and quality of life in people with COPD. 

Hypothesis: An eight week PR program is equivalent to a 12 week PR program at improving exercise capacity in people with COPD. 

Design: This is a multi-centre study where 68 participants will be recruited from pulmonary rehabilitation sites across the Sydney Local Health District. A randomised controlled trial design will be used with participants randomally allocated to one of two groups:
1. an eight week PR program or
2. a 12 week PR program.
Participants will be asked to complete exercise tests and questionnaires at baseline, four weeks, eight weeks, 12 weeks, six months and 12 months follow-up. 
Participants will also be asked to wear physical activity monitors at baseline, seven weeks, at completion of their respective exercise programs (eight weeks or 12 weeks), six months and 12 months  follow-up.
This research will determine if an eight week PR program is equivalent to a 12 week PR program.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Joshua Bishop

Address

Balmain Hospital
Physiotherapy Department
29 Booth Street,
BALMAIN, NSW, 2041

Country

Australia

Phone

+61293952093

Fax

[email protected]

Contact person for public queries

Name

Joshua Bishop

Address

Balmain Hospital
Physiotherapy Department
29 Booth Street,
BALMAIN, NSW, 2041

Country

Australia

Phone

+61293952093

Fax

[email protected]

Contact person for scientific queries

Name

Joshua Bishop

Address

Balmain Hospital
Physiotherapy Department
29 Booth Street,
BALMAIN, NSW, 2041

Country

Australia

Phone

+61293952093

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

de-identified data may be available on a request and approval from the ethics committee and sites would need to be obtained

What supporting documents are/will be available?

Doc. No.	Type	Email
9432	Study protocol	[email protected]
9433	Statistical analysis plan	[email protected]
9434	Informed consent form	[email protected]
9435	Ethical approval	[email protected]

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	Effect of a pulmonary rehabilitation programme of 8 weeks compared to 12 weeks duration on exercise capacity in people with chronic obstructive pulmonary disease (PuRe Duration): Protocol for a randomised controlled trial.	2020	https://dx.doi.org/10.1136/bmjresp-2020-000687
Embase	Changes in Exercise Capacity and Health-Related Quality of Life at Four and Eight Weeks of a Pulmonary Rehabilitation Program in People with COPD.	2021	https://dx.doi.org/10.1080/15412555.2021.2013793

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

Trial Review

Documents added manually

Documents added automatically