Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000408583
Ethics application status
Approved
Date submitted
3/08/2006
Date registered
19/09/2006
Date last updated
22/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of water-based exercise in chronic obstructive pulmonary disease
Scientific title
The effect of a water-based exercise program compared to a land-based exercise program on exercise capacity and health-related quality of life in chronic obstructive pulmonary disease patients with co-morbid conditions.
Secondary ID [1] 286790 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 1375 0
Condition category
Condition code
Respiratory 1468 1468 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised, controlled trial; 3 groups- 2 intervention and 1 control group. Intervention groups 1) water-based training 2) land-based training.
Intervention groups- twice weekly, centre-based supervised exercise training plus once weekly centre-based independent training sessions, for eight weeks.
Intervention code [1] 1266 0
Rehabilitation
Comparator / control treatment
Control group- usual care. Usual care - management of medications by GP and possibly respiratory physician
Control group
Active

Outcomes
Primary outcome [1] 2030 0
Functional exercise capacity measured by six-minute walk test, incremental shuttle walk test, endurance shuttle walk test.
Timepoint [1] 2030 0
At baseline and at 8 weeks.
Primary outcome [2] 2031 0
Quality of life measured by St George Respiratory Questionnaire, SF-36 and Chronic Respiratory Disease Questionnaire.
Timepoint [2] 2031 0
At baseline and at 8 weeks.
Secondary outcome [1] 3512 0
Hospital Anxiety and Depression Scale
Timepoint [1] 3512 0
Measured at initial assessment and at completion of the 8 weeks intervention or usual care.
Secondary outcome [2] 3513 0
Lung function
Timepoint [2] 3513 0
Measured at initial assessment and at completion of the 8 weeks intervention or usual care.
Secondary outcome [3] 3514 0
respiratory muscle strength.
Timepoint [3] 3514 0
Measured at initial assessment and at completion of the 8 weeks intervention or usual care.
Secondary outcome [4] 3515 0
Acceptability of water-based training
Timepoint [4] 3515 0
At the completion of the 8 weeks intervention
Secondary outcome [5] 3516 0
Compliance
Timepoint [5] 3516 0
At the completion of the 8 weeks intervention

Eligibility
Key inclusion criteria
Confirmed diagnosis of chronic obstructive pulmonary disease; stable condition; presence of one or more co-morbid conditions (BMI> or equal to 32, musculoskeletal conditions affecting the lumbar spine or lower limbs, neurolocical conditions, neuromuscular disorders and one or more lower-limb joint replacements restricting mobility and/or joint range of motion). Both male and female subjects will be included with no age limits as long as the inclusion crieria are met.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unstable cardiac disease, contra-indications to aquatic therapy, completed a pulmonary rehabilitation program in the last 12 months or attending maintenance exercise, inability to understand English, cognitive decline.

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)
Subjects will be randomised after initial baseline testing by a computer program. Allocation will be concealed by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation using a computer-based program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
In this study the comparisons are between water-based, land-based training and control (no training). Because of the type of training the subjects and therapist will not be blind to group allocation and it is not possible to make a sham treatment for these. The assessor will be blind to group allocation.
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2006
Actual
4/09/2006
Date of last participant enrolment
Anticipated
Actual
22/09/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 1605 0
Hospital
Name [1] 1605 0
Prince of Wales Hospital
Country [1] 1605 0
Australia
Funding source category [2] 1606 0
University
Name [2] 1606 0
The University of Sydney
Country [2] 1606 0
Australia
Primary sponsor type
Hospital
Name
Prince of Wales Hospital
Address
Sydney NSW
Country
Australia
Secondary sponsor category [1] 1410 0
University
Name [1] 1410 0
University of Sydney
Address [1] 1410 0
East Street Lidcombe NSW Australia 2141
Country [1] 1410 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3052 0
Prince of Wales Hospital (South Eastern Sydney Area Health Service HumanResearch Ethics Committee - Northern Section
Ethics committee address [1] 3052 0
Ethics committee country [1] 3052 0
Australia
Date submitted for ethics approval [1] 3052 0
Approval date [1] 3052 0
26/07/2006
Ethics approval number [1] 3052 0
06/176

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

Contacts
Principal investigator
Name 35594 0
Dr Renae McNamara
Address 35594 0
Prince of Wales Hospital
Barker St Randwick
NSW Australia 2031
Country 35594 0
Australia
Phone 35594 0
+612 9382 2851
Fax 35594 0
Email 35594 0
[email protected]
Contact person for public queries
Name 10455 0
Dr Renae McNamara
Address 10455 0
Physiotherapy Department
Prince of Wales Hospital
Barker Street
Randwick
NSW 2031
Country 10455 0
Australia
Phone 10455 0
+61 2 93822851
Fax 10455 0
Email 10455 0
[email protected]
Contact person for scientific queries
Name 1383 0
Jennifer Alison
Address 1383 0
Discipline of Physiotherapy
Faculty of Health Sciences
University of Sydney
PO Box 170
Lidcombe
NSW 1825
Country 1383 0
Australia
Phone 1383 0
+61 2 93519371
Fax 1383 0
Email 1383 0
[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
No additional documents have been identified.