Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000769684
Ethics application status
Approved
Date submitted
19/06/2014
Date registered
21/07/2014
Date last updated
21/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does tailoring a pulmonary rehabilitation programme with data from a maximal exercise cycle test data lead to better outcomes than traditional exercise prescription methods? A pilot study.
Scientific title
Evaluation of a pulmonary rehabilitation (PR) program using an exercise prescription that includes the maximal exercise cycle test (MECT) compared to a PR program using an exercise prescription that does not includes the MECT on exercise capacity in patients with chronic obstructive pulmonary disease
Secondary ID [1] 284833 0
Nil
Universal Trial Number (UTN)
U1111-1158-2012
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 292220 0
Condition category
Condition code
Respiratory 292556 292556 0 0
Chronic obstructive pulmonary disease
Physical Medicine / Rehabilitation 292634 292634 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group: Patients with COPD receiving a PR program using an exercise prescription that includes a Maximal Exercise Capacity Test (MECT)

The intervention group will be assessed using the MECT measured by cycle ergometer test. Measurements of ventilation and gas exchange will be made via with a calibrated flow sensor and gas analysers (OxyCon Pro; CareFusion Jaeger) with the patient breathing from a low deadspace ventilation mask sealed around the patient’s mouth and nose. The test will be based on the American Thoracic Society and American College of Chest Physicians protocol (ATS/ACCP, 2003). The patient will be asked to start with a resting phase of 3 minutes followed by 3 minutes of unloaded pedaling prior to the incremental phase. The intensity will be increased every minute by 5-25 W until patient reaches exhaustion or cannot maintain a pedaling rate of above 50 RPM. The patients will be strongly encouraged to maintain the pedaling rate. Breath-by-breath data analysis provides carbon dioxide production, oxygen consumption, tidal volume, breathing frequency, and minute ventilation can be determined. Maximum working capacity (Wmax) will be calculated as a percentage of predicted value depending on age, gender, and body mass index (Bruce et al., 1973; Hansen et al., 1984). Electrocardiogram and oxygen saturation will be continuously monitored during the test (Vonbank et al., 2012). The incremental phase will be completed between 8-12 minutes (Gloeckl et al., 2013). At the start, during, and end of the test patients will rate their breathlessness and fatigue using modified Borg scale (Borg, 1982). The data of this test will be used to tailor the PR intervention to the individual patients. All MECTs will be medically supervised. The test will be performed on a stationary bike. MECT data will be used by the physiotherapist to define the training approach (endurance or interval training) and the intensity of the exercises in the training. For the first 8 weeks, patients will have one 2-hour education session and 2 60-minute exercise sessions per week. The last 4 weeks, the patients continue with 2 60-minute exercise sessions per week, but do not have any further education sessions. The sessions are group-based sessions. The program is 12 weeks long. It has two groups of total 20-30 patients. Each group has 10-15 patients. The two sessions will start at the same time (i.e. morning and afternoon), where participants who attend the exercise in the morning will attend the education session in the afternoon and vice versa. The education topic areas are, but not limited to, self-Management, the Lungs and COPD management, medications, managing breathlessness, exercise and physical activity, nutrition and healthy eating, stress, anxiety and depression, airway clearance, energy conservation, continence, sexuality issues, swallowing and home oxygen. There will be one physiotherapist and one assistant per group. In the training, patients will have five different exercises; cycling, walking, walking stairs, lifting weights, and unsupported arm lifting.The exercise protocol is an adjusted version of a protocol which was proven effective in a previous study (Effing et al., 2011).
Intervention code [1] 289625 0
Rehabilitation
Comparator / control treatment
Control group: Patients with COPD receiving a PR program using an exercise prescription that does not include a Maximal Exercise Capacity Test (MECT). The intended number of participants per group is 20 participants.

The content, duration, and frequency of this PR program are the same as the PR program used in the intervention group. However, this PR program will be tailored using the six Minute Walk Test (6MWT) and the BORG scores for fatigue and breathlessness to define training intensities. The 6 MWT will be used to define the intensity for the control group where the evidence suggest a 60–80% is used to set the intensity. A score of 7 in Borg scale is also used to define the intensity.In exercise training sessions, there will be one physiotherapist and one assistant per group.
Control group
Active

Outcomes
Primary outcome [1] 292419 0
Exercise capacity measured with the six-minute walking test (MWT)
Timepoint [1] 292419 0
At baseline, 8 weeks, and at the end of 12 weeks of the program
Secondary outcome [1] 308901 0
Health Status measured with Chronic Respiratory Questionnaire-self-administered standardized (CRQ-SAS); and Short Form Health Survey (SF-36)
Timepoint [1] 308901 0
At baseline, 8 weeks, and at the end of 12 weeks of the program
Secondary outcome [2] 308902 0
Anxiety and depression measured with the Hospital Anxiety and Depression Scale (HADS)
Timepoint [2] 308902 0
At baseline, 8 weeks, and at the end of 12 weeks of the program

Eligibility
Key inclusion criteria
1) Referred to and selected for the PR at the Repatriation General Hospital.
2) At least six weeks since last hospitalization or four weeks since last exacerbation of respiratory condition.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) life expectancy of less than 12 months.
2) significant comorbidity including malignancy, cardiovascular disease, or musculoskeletal disease that severely limits performing exercise-training tasks and participation into the PR program.
3) severe psychiatric illness.
4) can not understand/read English.

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)
All eligible patients will be randomised using a computer minmisation program where the program will randomise participants by current smoking status. Thus the allocation will be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We are using a minimisation program to balance the groups, we will minimise differences between both groups with regard to current smoking status.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Baseline characteristics of both study groups will be described and compared using the student t-tests and chi-square tests. Subsequently, group outcome changes will be defined and compared between groups, using the independent t test. P value of less than 0.05 will define significant difference. All data will be analyzed using SPSS 21.0 software.

The targeted number for this prospective pilot study is a minimum of 20 patients per group. This number is not based on a power calculation, but a feasible number of patients to recruit. This study will provide us with important information about effect sizes and will point out whether a future RCT should be performed.

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
1/07/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 8314 0
5041 - Daw Park

Funding & Sponsors
Funding source category [1] 289441 0
Self funded/Unfunded
Name [1] 289441 0
NA
Country [1] 289441 0
Primary sponsor type
Hospital
Name
Repatriation General Hospital
Address
216 Daws Rd, Daw Park SA 5041
Country
Australia
Secondary sponsor category [1] 288131 0
None
Name [1] 288131 0
NA
Address [1] 288131 0
NA
Country [1] 288131 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291200 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 291200 0
Southern Adelaide Clinical
Human Research Ethics Committee

The Flats G5 – Rooms 3 and 4
Flinders Drive
Flinders Medical Centre, Bedford Park SA 5042
Ethics committee country [1] 291200 0
Australia
Date submitted for ethics approval [1] 291200 0
Approval date [1] 291200 0
19/06/2014
Ethics approval number [1] 291200 0
558.13 - HREC/13/SAC/394

Summary
Brief summary
This pilot study will provide information regarding effect sizes, distribution of results and the feasibility of comparing two PR approaches: a PR approach in which the MECT is added to the PR assessment to further tailor the intervention and a PR approach that will not require this MECT information. Data from this pilot study will inform the investigators regarding the design of a larger multi-centre RCT to evaluate the effectiveness of both exercise prescription approaches in pulmonary rehabilitation
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 120 120 0 0
/AnzctrAttachments/366566-RGH PR Protocol.doc

Contacts
Principal investigator
Name 49322 0
Dr Tanja Effing
Address 49322 0
Repatriation General Hospital
216 Daws Rd, Daw Park SA 5041
Country 49322 0
Australia
Phone 49322 0
+61 8 82751189
Fax 49322 0
Email 49322 0
[email protected]
Contact person for public queries
Name 49323 0
Dr Tanja Effing
Address 49323 0
Repatriation General Hospital
216 Daws Rd, Daw Park SA 5041
Country 49323 0
Australia
Phone 49323 0
+61 8 82751189
Fax 49323 0
Email 49323 0
[email protected]
Contact person for scientific queries
Name 49324 0
Dr Tanja Effing
Address 49324 0
Repatriation General Hospital
216 Daws Rd, Daw Park SA 5041
Country 49324 0
Australia
Phone 49324 0
+61 8 82751189
Fax 49324 0
Email 49324 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
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Documents added automatically
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