Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000679684
Ethics application status
Approved
Date submitted
28/09/2005
Date registered
21/10/2005
Date last updated
21/10/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of arm training in patients with COPD
Scientific title
The effect of arm endurance training, arm strength training, or a combination of strength and endurance training on supported and unsupported arm exercise capacity and arm muscle strength in patients with COPD
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disaese (COPD) 827 0
Condition category
Condition code
Respiratory 894 894 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions:
All subjects perform lower limb exercise training three times per week
In addition subjects are randomally allocated to one of the following groups:
Arm endurance training
Arm strength training
Arm endurance and strength training
No arm training (Control Group)
Intervention code [1] 686 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1158 0
Peak and endurance arm exercise capacity capacity
Timepoint [1] 1158 0
Measurements pre training and following an 8 week training program
Secondary outcome [1] 2123 0
Upper limb strength
Timepoint [1] 2123 0
Measurements pre training and following an 8 week training program.
Secondary outcome [2] 2124 0
Quality of life
Timepoint [2] 2124 0
Measurements pre training and following an 8 week training program.

Eligibility
Key inclusion criteria
Diagnosed COPD (FEV1/FVC <70%).
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any musculoskeletal, neurological, cardiovascular limitations to arm exercise.

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)
the sequence was concealed in opaque envelopes until interventions were assigned
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generation in blocks using the website www.randomization.com which is recommended as the best of the freely available, internet-based randomisation services (BMC medical Research Methodology 2004,4:26)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 985 0
Charities/Societies/Foundations
Name [1] 985 0
Community Health and Tuberculosis Australia
Country [1] 985 0
Australia
Primary sponsor type
Hospital
Name
Department of Respiratory Medicine, Royal Prince Alfred Hospital
Address
Country
Australia
Secondary sponsor category [1] 849 0
University
Name [1] 849 0
Department of Physiotherapy, Royal Prince Alfred Hospital
Address [1] 849 0
Country [1] 849 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2295 0
Sydney South West Area Health Service (RPAH zone)
Ethics committee address [1] 2295 0
Ethics committee country [1] 2295 0
Australia
Date submitted for ethics approval [1] 2295 0
Approval date [1] 2295 0
Ethics approval number [1] 2295 0
Ethics committee name [2] 2296 0
Sydney South West Area Health Service (Concord zone)
Ethics committee address [2] 2296 0
Ethics committee country [2] 2296 0
Australia
Date submitted for ethics approval [2] 2296 0
Approval date [2] 2296 0
Ethics approval number [2] 2296 0

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

Contacts
Principal investigator
Name 36332 0
Address 36332 0
Country 36332 0
Phone 36332 0
Fax 36332 0
Email 36332 0
Contact person for public queries
Name 9875 0
Mr Bradley Speers
Address 9875 0
Department of Respiratory Medicine
Royal Prince Alfred Hospital
E11
Missenden Rd
Camperdown NSW 2050
Country 9875 0
Australia
Phone 9875 0
+61 432935177
Fax 9875 0
Email 9875 0
[email protected]
Contact person for scientific queries
Name 803 0
Dr Jennifer Alison
Address 803 0
School of Physiotherapy
Faculty of Health Sciences
University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 803 0
Australia
Phone 803 0
+61 2 93519371
Fax 803 0
Email 803 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.