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Trial registered on ANZCTR


Registration number
ACTRN12605000703606
Ethics application status
Approved
Date submitted
1/11/2005
Date registered
2/11/2005
Date last updated
10/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding the role of self-management education in the rehabilitation of patients with chronic obstructive pulmonary disease.
Scientific title
A randomised clinical trial examining the enhanced benefits in health outcomes with the addition of self-management education to exercise training in patients with chronic obstructive pulmonary disease (COPD).
Secondary ID [1] 287856 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. 852 0
Condition category
Condition code
Respiratory 919 919 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomized to receive either exercise training or exercise training and disease specific group self-management education. All participants will under go twice weekly exercise training sessions consisting of aerobic and strength training programs (duration of one hour of exercise) for eight weeks (total of 16 sessions). Those randomized to the self-management education group will also receive twice weekly education sessions conducted by a multidisciplinary team for eight weeks. Each session will be an hour in duration, and topics covered will include how to self-manage, the lungs and COPD management, airway clearance, managing breathlessness, stress, anxiety and depression, sexuality issues, continence, exercise and physical activity, nutrition and healthy eating, medications, community resources, energy conservation techniques and swallowing. To complement the group sessions, participants will also receive a booklet on the above topics and an action plan diary. The focus of the sessions is on facilitating behaviour change rather than delivery of information.
Intervention code [1] 745 0
Rehabilitation
Comparator / control treatment
The comparator group receives exercise training alone, with no education sessions as described above.
Control group
Active

Outcomes
Primary outcome [1] 1201 0
Healthcare utilization: general practitioner and physician visits.
Timepoint [1] 1201 0
Examined for the 12 months following completion of the intervention.
Primary outcome [2] 1202 0
Healthcare utilization: hospital admissions and length of stay.
Timepoint [2] 1202 0
Examined for the 12 months following completion of the intervention.
Primary outcome [3] 1203 0
Healthcare utilization: pharmaceutical usage.
Timepoint [3] 1203 0
Examined for the 12 months following completion of the intervention.
Primary outcome [4] 1204 0
Healthcare utilization: allied health professional attendances.
Timepoint [4] 1204 0
Examined for the 12 months following completion of the intervention.
Secondary outcome [1] 2192 0
Quality of Life (Chronic Respiratory Questionnaire: CRQ and the Assessment of Quality of Life: AQoL)
- Health Behaviour (The Health Education Impact Questionnaire: HEI-Q)
- Self-efficacy (General Self-Efficacy Scale - 12) - Exercise Tolerance (6 Minute Walk Test)
- Dyspnea (BORG Scale during exercise, and the Medical Research Council Dyspnea Scale).
Timepoint [1] 2192 0
Each of the outcomes will be measured prior to intervention, within two weeks post and at 3, 6 and 12 month time points following the intervention.

Eligibility
Key inclusion criteria
Primary diagnosis of COPD as classified by NHLBI/WHO Global Initiative for COPD: FEV1 of <80% predicted and a FEV1/FVC ratio of < 70% (as measured with a vitalograph) - Participant reported symptomatic dyspnea (shortness of breath) interfering with their ability to perform normal activities of daily living.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Attendance at pulmonary rehabilitation program in the preceding two years- Non-English speaking- A primary diagnosis of another chronic respiratory conditions (for example bronchiectasis, cystic fibrosis, pulmonary fibrosis, or lung carcinoma) - Another condition which would limit their ability to exercise (e.g. arthritis, cardiac conditions, lower back pain, Parkinson's disease)- A medically documented cognitive condition which would limit their ability to learn (e.g. Alzheimer's, dementia, short term memory loss following stroke or head injury).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruitment occurs before any assessment, and a second physiotherapists (not involved in recruitment or assessment) allocates participant to group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
By computer generated random number table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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] 4602 0
Austin Health - Austin Hospital - Heidelberg

Funding & Sponsors
Funding source category [1] 1014 0
Self funded/Unfunded
Name [1] 1014 0
Address [1] 1014 0
Country [1] 1014 0
Primary sponsor type
Individual
Name
Felicity Blackstock
Address
School of Physiotherapy, La Trobe University, Victoria, Australia 3086
Country
Australia
Secondary sponsor category [1] 877 0
None
Name [1] 877 0
Nil
Address [1] 877 0
Country [1] 877 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2322 0
La Trobe University
Ethics committee address [1] 2322 0
Ethics committee country [1] 2322 0
Australia
Date submitted for ethics approval [1] 2322 0
Approval date [1] 2322 0
21/09/2005
Ethics approval number [1] 2322 0
Ethics committee name [2] 2323 0
Department of Veterans Affairs
Ethics committee address [2] 2323 0
Ethics committee country [2] 2323 0
Australia
Date submitted for ethics approval [2] 2323 0
Approval date [2] 2323 0
10/06/2005
Ethics approval number [2] 2323 0
Ethics committee name [3] 2324 0
Austin Health
Ethics committee address [3] 2324 0
Ethics committee country [3] 2324 0
Australia
Date submitted for ethics approval [3] 2324 0
Approval date [3] 2324 0
17/02/2006
Ethics approval number [3] 2324 0

Summary
Brief summary
Method: A randomised trial with allocation concealment, assessor blinded to group allocation and intention-to-treat analysis was conducted. Two hundred and sixty-seven people with COPD [mean age 72(9) years, FEV1 59(23)% predicted] were allocated to receive either eight weeks of twice-weekly group exercise training plus education or exercise training alone. Education was disease specific with a self-management focus. Primary outcome measures included six-minute walk distance and Chronic Respiratory Questionnaire. Secondary outcomes included dyspnoea, health behaviours, generic health related quality of life, self-efficacy, and healthcare usage with measurements taken immediately following completion and at six and 12 months.
Results: There were no significant differences that indicated greater improvement in any health outcome with the addition of education. The two intervention groups had similar significant improvements immediately following intervention, and these were maintained comparably in the subsequent 12 months.
Conclusions: The results of this investigation suggest that disease-specific group education is not an essential component of pulmonary rehabilitation. Pulmonary rehabilitation based on exercise training is an effective option in the management of patients with COPD if multidisciplinary education cannot be offered.
Trial website
Trial related presentations / publications
Blackstock, F.C., Webster, K.E., McDonald, C.F. & Hill, C.J. (2014). Comparable improvements achieved in chronic obstructive pulmonary disease through pulmonary rehabilitation with and without a structured educational intervention: a randomized controlled trial. Respirology, 19(2), 193-202.
Blackstock, F., Webster, K.E., McDonald, C.F. & Hill, C.J. (2013) Pulmonary rehabilitation: can we predict who responds if the program includes an education component? Australian Physiotherapy Association Conference, October (Melbourne).
Blackstock F., Hill, C.J., Webster, K.E. & McDonald, C. (2011) The addition of education to exercise in pulmonary rehabilitation for patients with COPD does not result in greater improvements in outcomes. Australian Physiotherapy Association Conference, October (Brisbane).
Blackstock F, Hill, C.J., Webster, K.E. & McDonald, C. (2011) Exercise training alone achieves improvements comparable to pulmonary rehabilitation in COPD. TSANZ Annual Scientific Meeting, April (Perth).
Public notes

Contacts
Principal investigator
Name 35905 0
Dr Felicity Blackstock
Address 35905 0
School of Physiotherapy Faculty of Health Sciences La Trobe University Melbourne VIC 3086
Country 35905 0
Australia
Phone 35905 0
+61 9478 626 203
Fax 35905 0
Email 35905 0
F.Blackstock@westernsydney.edu.au
Contact person for public queries
Name 9934 0
A/Prof Felicity Blackstock
Address 9934 0
Physiotherapy,
Building 24.2.115 Campbelltown Campus
Western Sydney University
Locked Bag 1797,
Penrith, NSW 2751, Australia
Country 9934 0
Australia
Phone 9934 0
+61 0478 626 203
Fax 9934 0
Nil fax
Email 9934 0
F.Blackstock@westernsydney.edu.au
Contact person for scientific queries
Name 862 0
A/Prof Felicity Blackstock
Address 862 0
Physiotherapy,
Building 24.2.115 Campbelltown Campus
Western Sydney University
Locked Bag 1797,
Penrith, NSW 2751, Australia
Country 862 0
Australia
Phone 862 0
+61 0478 626 203
Fax 862 0
Email 862 0
F.Blackstock@westernsydney.edu.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