Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001216303
Ethics application status
Approved
Date submitted
16/08/2017
Date registered
21/08/2017
Date last updated
18/09/2019
Date data sharing statement initially provided
18/09/2019
Date results information initially provided
18/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of pulmonary rehabilitation on pain in people with chronic obstructive pulmonary disease (COPD)
Scientific title
The effect of pulmonary rehabilitation on pain in people with chronic obstructive pulmonary disease (COPD)
Secondary ID [1] 292671 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 304416 0
Condition category
Condition code
Musculoskeletal 303745 303745 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Completing an 8-week program of pulmonary rehabilitation consisting of exercise and education. The exercise prescription is based on international guidelines, aiming for 80% of the 6MWD for aerobic training and resistance training set at 10RM for upper and lower limb exercises. Patients will attend twice per week, with commencement of a home program when suitable. Education sessions will comprise of a number of salient topics relevant to people with chronic obstructive pulmonary disease
Intervention code [1] 298905 0
Not applicable
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303116 0
Presence of pain according to Brief Pain inventory (question 1: - have you experienced pain (other than a toothache, minor sprain) within the last 24 hours? Yes/No
Timepoint [1] 303116 0
Beginning and end of pulmonary rehabilitation
Secondary outcome [1] 337910 0
Hospital Anxiety and Depression Scale
Timepoint [1] 337910 0
Beginning and end of pulmonary rehabilitation
Secondary outcome [2] 337911 0
Pain coping behaviour questionnaire
Timepoint [2] 337911 0
beginning and end of pulmonary rehabilitation
Secondary outcome [3] 337912 0
6-minute walk distance
Timepoint [3] 337912 0
beginning and end of pulmonary rehabilitation
Secondary outcome [4] 337913 0
Disease-specific health related quality of life using the Chronic Respiratory Questionnaire
Timepoint [4] 337913 0
beginning and end of pulmonary rehabilitation

Eligibility
Key inclusion criteria
Individuals with diagnosis of COPD (FEV1/FVC <70), with smoking history of > 10 pack years, clinically stable, with no exacerbation in the previous 6 weeks
May have pain present or absent at the beginning of pulmonary rehabilitation. All participants are undergoing pulmonary rehabilitation as part of their standard care.
Minimum age
40 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Evidence of exacerbation of COPD within the last 6 weeks.
Predominant diagnosis of respiratory condition other than COPD

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Comparison of two groups is based on the whether they indicate the presence of pain at the beginning of rehabilitation or the absence of pain. Their clinical outcomes between the two groups at the beginning and end of rehabilitation will be compared using repeated measures analysis of variance. with alpha less than 0.05

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/09/2017
Actual
25/09/2017
Date of last participant enrolment
Anticipated
19/08/2019
Actual
25/02/2019
Date of last data collection
Anticipated
4/11/2019
Actual
29/04/2019
Sample size
Target
88
Accrual to date
Final
68
Recruitment outside Australia
Country [1] 9152 0
Canada
State/province [1] 9152 0
Ontario

Funding & Sponsors
Funding source category [1] 297311 0
Charities/Societies/Foundations
Name [1] 297311 0
Ontario Respiratory Care Society
Country [1] 297311 0
Canada
Primary sponsor type
Individual
Name
Dina Brooks
Address
West Park Healthcare Centre
82 Buttonwood Ave
Toronto, M6M 2J5
Country
Canada
Secondary sponsor category [1] 296280 0
None
Name [1] 296280 0
Address [1] 296280 0
Country [1] 296280 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298416 0
Joint West Park Healthcare Centre - Toronto Grace Hospital Joint Research Ethics Board
Ethics committee address [1] 298416 0
82 Buttonwood Ave
Toronto, M6M 2J5
Ethics committee country [1] 298416 0
Canada
Date submitted for ethics approval [1] 298416 0
05/06/2017
Approval date [1] 298416 0
17/07/2017
Ethics approval number [1] 298416 0

Summary
Brief summary
This study examines the effect of pulmonary rehabiltiation on pain in people with COPD, to determine if the exercise program aggravates or relieves pain for those experiencing pain at the commencement of pulmonary rehabilitation. For those without pain at the start of rehabilitation, the study will determine whether pulmonary rehabilitation results in pain at its conclusion.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77014 0
Dr Annemarie Lee
Address 77014 0
West Park Healthcare Centre
82 Buttonwood Ave
Toronto, M6M 2J5
Country 77014 0
Canada
Phone 77014 0
+1 416 243 3653
Fax 77014 0
Email 77014 0
[email protected]
Contact person for public queries
Name 77015 0
Dr Annemarie Lee
Address 77015 0
West Park Healthcare Centre
82 Buttonwood Ave
Toronto, M6M 2J5
Country 77015 0
Canada
Phone 77015 0
+1 416 243 3653
Fax 77015 0
Email 77015 0
[email protected]
Contact person for scientific queries
Name 77016 0
Dr Annemarie Lee
Address 77016 0
West Park Healthcare Centre
82 Buttonwood Ave
Toronto, M6M 2J5
Country 77016 0
Canada
Phone 77016 0
+1 416 243 3653
Fax 77016 0
Email 77016 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


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.