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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
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
Secondary ID [1] 290281 0
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 300518 0
Condition category
Condition code
Respiratory 300379 300379 0 0
Chronic obstructive pulmonary disease
Physical Medicine / Rehabilitation 300752 300752 0 0
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] 296084 0
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] 299831 0
Endurance Shuttle Walk Test (ESWT)
Timepoint [1] 299831 0
Baseline, four weeks, eight weeks, 12 weeks, six months and 12 months.
Secondary outcome [1] 328231 0
St George's Respiratory Questionnaire (SGRQ)
Timepoint [1] 328231 0
Baseline, four weeks, eight weeks, 12 weeks, six months and 12 months.
Secondary outcome [2] 328232 0
COPD Assessment Test (CAT)
Timepoint [2] 328232 0
Baseline, four weeks, eight weeks, 12 weeks, six months and 12 months.
Secondary outcome [3] 328233 0
Hospital Anxiety Depression Scale (HADS)
Timepoint [3] 328233 0
Baseline, four weeks, eight weeks, 12 weeks, six months and 12 months.
Secondary outcome [4] 328234 0
Physical Activity via Actigraph and ActivPAL
Timepoint [4] 328234 0
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] 396849 0
Hospital Admissions using health district medical records
Timepoint [5] 396849 0
Six months and 12 months post completion of pulmonary rehabilitation program (eight or 12 weeks respectively)
Secondary outcome [6] 396850 0
Exercise Adherence via number of pulmonary rehabilitation sessions attended during the pulmonary rehabiltaiton program
Timepoint [6] 396850 0
At completion of pulmonary rehabilitation program (eight or 12 weeks respectively)
Secondary outcome [7] 396851 0
Length of Stay using health district medical records
Timepoint [7] 396851 0
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?
No
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
72
Accrual to date
66
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9845 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 9846 0
Balmain Hospital - Balmain
Recruitment hospital [3] 9847 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 18625 0
2050 - Camperdown
Recruitment postcode(s) [2] 18626 0
2041 - Balmain
Recruitment postcode(s) [3] 18627 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 294661 0
Government body
Name [1] 294661 0
Sydney Local Health District
Country [1] 294661 0
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] 293756 0
None
Name [1] 293756 0
Address [1] 293756 0
Country [1] 293756 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296097 0
Sydney Local Health District Research Ethics Committee (RPAH zone)
Ethics committee address [1] 296097 0
Ethics committee country [1] 296097 0
Australia
Date submitted for ethics approval [1] 296097 0
01/08/2016
Approval date [1] 296097 0
21/09/2016
Ethics approval number [1] 296097 0

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

Contacts
Principal investigator
Name 69506 0
Mr Joshua Bishop
Address 69506 0
Balmain Hospital
Physiotherapy Department
29 Booth Street,
BALMAIN, NSW, 2041
Country 69506 0
Australia
Phone 69506 0
+61293952093
Fax 69506 0
Email 69506 0
joshua.bishop@sswahs.nsw.gov.au
Contact person for public queries
Name 69507 0
Joshua Bishop
Address 69507 0
Balmain Hospital
Physiotherapy Department
29 Booth Street,
BALMAIN, NSW, 2041
Country 69507 0
Australia
Phone 69507 0
+61293952093
Fax 69507 0
Email 69507 0
joshua.bishop@sswahs.nsw.gov.au
Contact person for scientific queries
Name 69508 0
Joshua Bishop
Address 69508 0
Balmain Hospital
Physiotherapy Department
29 Booth Street,
BALMAIN, NSW, 2041
Country 69508 0
Australia
Phone 69508 0
+61293952093
Fax 69508 0
Email 69508 0
joshua.bishop@sswahs.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.TypeCitationLinkEmailOther DetailsAttachment
9432Study protocol  joshua.bishop@health.nsw.gov.au
9433Statistical analysis plan  joshua.bishop@health.nsw.gov.au
9434Informed consent form  joshua.bishop@health.nsw.gov.au
9435Ethical approval  joshua.bishop@health.nsw.gov.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect 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.2020https://dx.doi.org/10.1136/bmjresp-2020-000687
EmbaseChanges in Exercise Capacity and Health-Related Quality of Life at Four and Eight Weeks of a Pulmonary Rehabilitation Program in People with COPD.2021https://dx.doi.org/10.1080/15412555.2021.2013793
N.B. These documents automatically identified may not have been verified by the study sponsor.