Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000496516
Ethics application status
Approved
Date submitted
2/11/2006
Date registered
4/12/2006
Date last updated
4/12/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prescribing cycle exercise training intensity from the six-minute walk test in patients with chronic obstructive pulmonary disease (COPD)
Scientific title
The effect of constant load cycle exercise, prescribed from a six-minute walk test, on oxygen consumption in patients with chronic obstructive pulmonary disease (COPD)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 1473 0
Condition category
Condition code
Respiratory 1569 1569 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ten minutes of constant load cycle exercise at 60% of calculated peak work rate for a single group
Intervention code [1] 1428 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2165 0
Oxygen consumption
Timepoint [1] 2165 0
Averaged over the last three minutes of constant load cycle exercise.
Secondary outcome [1] 3779 0
Dyspnoea averaged over the last three minutes of constant load cycle exercise.
Timepoint [1] 3779 0
Secondary outcome [2] 3780 0
Rate of perceived exertion averaged over the last three minutes of constant load cycle exercise.
Timepoint [2] 3780 0

Eligibility
Key inclusion criteria
Diagnosis of mild to severe chronic obstructive pulmonary disease with a ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) (FEV1/FVC) < 70% with an FEV1 < 80% predicted.
Minimum age
45 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Musculoskeletal, cardiovascular or neurological co-morbidities that may limit or influence exercise performance. Fever, increased sputum, hospital admission in the previous month or on long term oxygen therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/04/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1711 0
University
Name [1] 1711 0
University of Sydney
Country [1] 1711 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 1510 0
Hospital
Name [1] 1510 0
Royal Prince Alfred Hospital
Address [1] 1510 0
Country [1] 1510 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3168 0
Royal Prince Alfred Hospital through Sydney South West Area Health Services Ethics Committee
Ethics committee address [1] 3168 0
Ethics committee country [1] 3168 0
Australia
Date submitted for ethics approval [1] 3168 0
Approval date [1] 3168 0
02/08/2005
Ethics approval number [1] 3168 0
X05-0164
Ethics committee name [2] 3169 0
The University of Sydney, Human Research Ethics Committee
Ethics committee address [2] 3169 0
Ethics committee country [2] 3169 0
Australia
Date submitted for ethics approval [2] 3169 0
Approval date [2] 3169 0
25/08/2005
Ethics approval number [2] 3169 0
8539

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

Contacts
Principal investigator
Name 27362 0
Address 27362 0
Country 27362 0
Phone 27362 0
Fax 27362 0
Email 27362 0
Contact person for public queries
Name 10617 0
Assoc/Prof Jennifer Alison
Address 10617 0
Discipline of Physiotherapy
Faculty of Health Sciences
University of Sydney
Po Box 170
Lidcombe
NSW 1825
Country 10617 0
Australia
Phone 10617 0
+61 2 93519371
Fax 10617 0
+61 2 93519601
Email 10617 0
j.alison@fhs.usyd.edu.au
Contact person for scientific queries
Name 1545 0
Assoc/Prof Jennifer Alison
Address 1545 0
Discipline of Physiotherapy
Faculty of Health Sciences
University of Sydney
Po Box 170
Lidcombe
NSW 1825
Country 1545 0
Australia
Phone 1545 0
+61 2 93519371
Fax 1545 0
+61 2 93519601
Email 1545 0
j.alison@fhs.usyd.edu.au

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.