Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000153910
Ethics application status
Approved
Date submitted
15/01/2020
Date registered
13/02/2020
Date last updated
2/07/2021
Date data sharing statement initially provided
13/02/2020
Date results information initially provided
13/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
How should we measure fitness in patients scheduled for knee and hip replacement surgery?
Scientific title
A crossover comparison of four cardiopulmonary exercise testing modalities to assess peak oxygen consumption in severe lower-limb osteoarthritis patients
Secondary ID [1] 300265 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 315844 0
Condition category
Condition code
Musculoskeletal 314126 314126 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will conduct a four-arm crossover (within participants) study, measuring peak oxygen consumption across cycle, treadmill, cross-trainer and arm ergometer modalities, in those with severe hip or knee osteoarthritis.

Fifteen participants will be recruited to perform maximal, symptom-limited exercise testing on each exercise modality utilising an incremental protocol. Participants will complete a 3-5 minute warm-up, before exercise intensity increases every 1-2 minutes, until volitional fatigue or test termination; each exercise test takes approximately 8-12 minutes (excluding warm-up). The testing will be administered and supervised by a registered clinical exercise physiologist (with 12 years experience), who is also a university research student. Testing will be conducted at the Dunedin Public Hospital. Tests will be one-on-one sessions, separated by at least 4 days to ensure adequate washout between exercise tests.

Participants will be reimbursed $5 per visit to cover travel expenses.
Intervention code [1] 316542 0
Diagnosis / Prognosis
Comparator / control treatment
Active control (crossover study)
Control group
Active

Outcomes
Primary outcome [1] 322514 0
Oxygen consumption, assessed via metabolic cart.
Timepoint [1] 322514 0
Peak exercise across all four exercise tests.
Secondary outcome [1] 378768 0
Oxygen consumption at the anaerobic threshold, assessed via metabolic cart.
Timepoint [1] 378768 0
Across all four exercise tests
Secondary outcome [2] 378769 0
Anaerobic threshold as a percentage of peak oxygen consumption, assessed via metabolic cart.
Timepoint [2] 378769 0
Across all four exercise tests
Secondary outcome [3] 378770 0
Heart rate, assessed via 12-lead electrocardiogram and heart rate band.
Timepoint [3] 378770 0
Peak exercise across all four exercise tests
Secondary outcome [4] 378771 0
Respiratory exchange ratio, assessed via metabolic cart.
Timepoint [4] 378771 0
Peak exercise across all four exercise tests
Secondary outcome [5] 378772 0
Systolic blood pressure, assessed via aneroid sphygmomanometer.
Timepoint [5] 378772 0
Prior to initial exercise test and peak exercise across all four exercise tests
Secondary outcome [6] 378773 0
Diastolic blood pressure, assessed via aneroid sphygmomanometer.
Timepoint [6] 378773 0
Prior to initial exercise test and peak exercise across all four exercise tests
Secondary outcome [7] 378774 0
Heart rate as a percentage of predicted maximum heart rate, assessed via 12-lead electrocardiogram and heart rate band.
Timepoint [7] 378774 0
Peak exercise across all four exercise tests
Secondary outcome [8] 378775 0
Minute ventilation, assessed via metabolic cart.
Timepoint [8] 378775 0
Peak exercise across all four exercise tests
Secondary outcome [9] 378776 0
Oxygen uptake efficiency slope, assessed via metabolic cart.
Timepoint [9] 378776 0
Across all four exercise tests
Secondary outcome [10] 378777 0
Rating of percieved exertion, assessed via Borg Rating of Percieved Exertion scale.
Timepoint [10] 378777 0
Peak exercise across all four exercise tests
Secondary outcome [11] 378778 0
Pain score, assessed via Visual Analogue Scale.
Timepoint [11] 378778 0
Pre-exercise and post-exercise across all four exercise tests
Secondary outcome [12] 378779 0
Maximal exercise test acceptability questionnaire
Timepoint [12] 378779 0
Post exercise test following all four exercise tests

Eligibility
Key inclusion criteria
- Patient meets the threshold for elective arthroplasty at Dunedin Public Hospital or is expected to meet the threshold within the next year;
- Patient is able to travel to the study centre to complete all sessions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Contraindication to maximal exercise testing;
- Angina;
- Recent myocardial infarction (< 3 months ago);
- Implanted cardiac device (i.e. ICD, pacemaker etc.);
- Charnley C type patients;
- Staged bilateral total joint replacement;
- Upper-limb pathology that limits upper-limb exercise, e.g., shoulder-joint osteoarthritis;
- Any other medical condition deemed a significant risk to study participation;
- Scheduled arthroplasty precluding completion of all four maximal exercise tests.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will involve contacting the holder of the allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All initial exercise tests performed on a cycle ergometer. Exercise modality for the following three maximal exercise tests will be randomised by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A sample size of 15 has been selected based on consultation with a biostatistician and previous literature.

A repeated-measures analysis of variance (ANOVA) will be used to compare differences in the primary (i.e., VO2peak) and secondary (i.e., other CPET data, pain scores etc.) variables across the four exercise modalities. Post-hoc testing will be performed if statistical significance (p <0.05) is observed, to elucidate differences between groups. Non-parametric data will be analysed using the Friedman Test. If a statistical significance is observed, Wilcoxon signed rank tests will determine between group differences.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/01/2019
Date of last participant enrolment
Anticipated
Actual
31/07/2019
Date of last data collection
Anticipated
Actual
2/09/2019
Sample size
Target
15
Accrual to date
Final
15
Recruitment outside Australia
Country [1] 22224 0
New Zealand
State/province [1] 22224 0
Dunedin

Funding & Sponsors
Funding source category [1] 304689 0
University
Name [1] 304689 0
University of Otago
Country [1] 304689 0
New Zealand
Primary sponsor type
Individual
Name
Dr Kate Thomas
Address
Department of Surgical Sciences
Dunedin School of Medicine
PO Box 913
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 304998 0
Individual
Name [1] 304998 0
Brendon Roxburgh
Address [1] 304998 0
Department of Surgical Sciences
Dunedin School of Medicine
PO Box 913
Dunedin 9054
Country [1] 304998 0
New Zealand
Secondary sponsor category [2] 305000 0
Individual
Name [2] 305000 0
Assoc. Prof. David Gwynne-Jones
Address [2] 305000 0
Department of Surgical Sciences
Dunedin School of Medicine
PO Box 913
Dunedin 9054
Country [2] 305000 0
New Zealand
Secondary sponsor category [3] 305001 0
Individual
Name [3] 305001 0
Prof. Jim Cotter
Address [3] 305001 0
School of Physical Education, Sport and Exercise Sciences
University of Otago
46 Union St West
PO Box 913
Dunedin 9054
Country [3] 305001 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305109 0
Health and Disability Ethics Committee
Ethics committee address [1] 305109 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 305109 0
New Zealand
Date submitted for ethics approval [1] 305109 0
13/08/2018
Approval date [1] 305109 0
31/10/2018
Ethics approval number [1] 305109 0
18/NTA/148

Summary
Brief summary
Cardiopulmonary exercise testing (CPET) is the gold standard for cardiorespiratory fitness (VO2peak) assessment. CPET is increasingly being used as a preoperative assessment tool, due to its ability to identify and objectively risk stratify patients who may be more vulnerable to the stress of surgery, and those who may benefit from more intensive perioperative care. Traditionally performed on a cycle, CPET can be difficult to perform for those with lower-limb osteoarthritis (OA). Due to population increases in age and obesity, OA prevalence is predicted to continue increasing. These increases are also likely to result in more complex surgical procedures on higher risk individuals, resulting in greater need for CPET to risk stratify and assess patient suitability for surgery. Therefore, it is essential the optimal exercise modality for performing CPET in these patients in known, particularly if traditionally used cycle ergometry may not be the most suitable for those with mobility issues or pain. This study will compare CPET variables (i.e., peak oxygen consumption, anaerobic threshold) on four different exercise modalities (treadmill, cycle, arm ergometer and elliptical cross-trainer), in patients with severe lower-limb OA.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99294 0
Dr Kate Thomas
Address 99294 0
Department of Surgical Sciences
Dunedin School of Medicine
PO Box 913
Dunedin 9054
Country 99294 0
New Zealand
Phone 99294 0
+64 273527990
Fax 99294 0
Email 99294 0
[email protected]
Contact person for public queries
Name 99295 0
Dr Kate Thomas
Address 99295 0
Department of Surgical Sciences
Dunedin School of Medicine
PO Box 913
Dunedin 9054
Country 99295 0
New Zealand
Phone 99295 0
+64 273527990
Fax 99295 0
Email 99295 0
[email protected]
Contact person for scientific queries
Name 99296 0
Dr Kate Thomas
Address 99296 0
Department of Surgical Sciences
Dunedin School of Medicine
PO Box 913
Dunedin 9054
Country 99296 0
New Zealand
Phone 99296 0
+64 273527990
Fax 99296 0
Email 99296 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Roxburgh, B. H., H. A. Campbell, J. D. Cotter, U. ... [More Details]

Documents added automatically
No additional documents have been identified.