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Trial registered on ANZCTR


Registration number
ACTRN12608000126314
Ethics application status
Approved
Date submitted
3/03/2008
Date registered
10/03/2008
Date last updated
6/11/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
To investigate the benefit of cycling and flat-ground walking in people with Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
Evaluation of the physiological and psychological benefits of cycling and flat-ground walking training in people with Chronic Obstructive Pulmonary Disease (COPD): A randomised, single blind trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic obstructive pulmonary disease (COPD) 2899 0
Condition category
Condition code
Respiratory 3034 3034 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised, controlled;
People will be randomly allocated into one of two groups.
The first group is flat-ground walking group
People in this group will be trained in the rehabilitation gym, walking around a rectanglar track starting from 30 minutes and gradually increase up to 45 minutes by week 6. The training will go for 8 weeks, 3 times per week. The walking speed of each individual is based on their incremental shuttle walk test result (75% of their peak walking speed). We aim to increase their walking speed according to their exercise tolerance each week.
Intervention code [1] 2628 0
Rehabilitation
Comparator / control treatment
People will be randomly allocated into one of two groups.
The second group is cycling group
People in this group will be trained in the rehabilitation gym with a stationary bike, starting with 30 minutes training and gradually increase up to 45 minutes. The initial intensity is set at 60% of their peak work rate achieved in the incremental cycle test. The training will go for 8 weeks, three times per week. We aim to increase their exercise intensity according to their exercise tolerance each week.
Control group
Active

Outcomes
Primary outcome [1] 3916 0
Functional exercise capacity - assessed by the incremental shuttle walk test and the endurance shuttle walk test
Timepoint [1] 3916 0
At baseline and at 8 weeks
Primary outcome [2] 3917 0
Health related quality of life - assessed by chronic respiratory disease questionnaire
Timepoint [2] 3917 0
At baseline and at 8 weeks
Secondary outcome [1] 6590 0
Exercise capacity - assessed by the incremental and endurance cycle test
Timepoint [1] 6590 0
At baseline and at 8 weeks
Secondary outcome [2] 6591 0
Lung function
Timepoint [2] 6591 0
Measured at baseline only
Secondary outcome [3] 6592 0
Compliance
Timepoint [3] 6592 0
At the completion of the 8 week intervention
Secondary outcome [4] 6593 0
Acceptability of the training interventions - cycling and flat-ground walking training
Timepoint [4] 6593 0
At the completion of the 8-week intervention

Eligibility
Key inclusion criteria
Chronic obstructive pulmonary disease; stable condition; Both male and female participants will be included with no age limits as long as the inclusion crieria are met.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unstable cardiac disease, completed a pulmonary rehabilitation program in the last 12 months or attending maintenance exercise, inability to understand English, Body Mass Index (BMI) over or equal to 35 kg/m²

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)
participants will be randomised after initial baseline testing by a computer program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation using a computer-based program. The stratification is based on the percentage of predicted six-minute walking distance, forced expiratory volume in the first second (FEV1), symptom which limits the peak incremental cycle test performance
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
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)
Recruitment postcode(s) [1] 790 0
2139

Funding & Sponsors
Funding source category [1] 3153 0
Self funded/Unfunded
Name [1] 3153 0
Address [1] 3153 0
Country [1] 3153 0
Primary sponsor type
University
Name
The University of Sydney
Address
University of Sydney
Faculty of Health Sciences
Cumberland Campus C42
75 East St
Lidcombe NSW 2141
Country
Australia
Secondary sponsor category [1] 2829 0
Hospital
Name [1] 2829 0
Concord Repatriation General Hospital
Address [1] 2829 0
Hospital Road
Concord NSW 2139
Country [1] 2829 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5131 0
Concord Hospital (Eastern Zone of Sydney South West Area Health Service Human Research Ethics Committee)
Ethics committee address [1] 5131 0
Concord Repatriation General Hospital
Ethics committee country [1] 5131 0
Australia
Date submitted for ethics approval [1] 5131 0
Approval date [1] 5131 0
13/02/2006
Ethics approval number [1] 5131 0
CH62/6/2005-083-J Alison

Summary
Brief summary
The aim of the project is to determine whether the benefit of flat-ground walking training is similar to cycling training in improving exercise capacity and health related quality of life (HRQoL) in patients with chronic obstructive pulmonary disease (COPD).

Hypothesis: On completion of an eight-week training program, subjects with COPD will demonstrate similar improvement in exercise capacity and HRQoL in the flat-ground walking training group and the cycling grop.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28419 0
Address 28419 0
Country 28419 0
Phone 28419 0
Fax 28419 0
Email 28419 0
Contact person for public queries
Name 11576 0
Wai Man Regina Leung
Address 11576 0
Institute of Sports Medicine
Hospital Road
Concord NSW 2139
Country 11576 0
Australia
Phone 11576 0
+ 61 2 97677602
Fax 11576 0
Email 11576 0
regina.leung@email.cs.nsw.gov.au
Contact person for scientific queries
Name 2504 0
Associate Professor Jenny Alison
Address 2504 0
Discipline of Physiotherapy
Faculty of Health Sciences
University of Sydney
Cumberland Campus C42
75 East St
Lidcombe NSW 2141
Country 2504 0
Australia
Phone 2504 0
+61 2 93519371
Fax 2504 0
Email 2504 0
j.alison@fhs.usyd.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