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Trial registered on ANZCTR


Registration number
ACTRN12618001358235p
Ethics application status
Not yet submitted
Date submitted
8/08/2018
Date registered
13/08/2018
Date last updated
13/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of preoperative heat therapy and high-intensity interval training for prehabilitation in patients awaiting hip or knee arthroplasties
Scientific title
Optimisation of preoperative cardiovascular fitness in patients awaiting hip or knee arthroplasty: The heat vs. HIIT study
Secondary ID [1] 295697 0
None
Universal Trial Number (UTN)
U1111-1218-7859
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 309079 0
Prehabilitation 309080 0
Arthroplasty 309081 0
Condition category
Condition code
Musculoskeletal 307957 307957 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 308059 308059 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Heat Therapy
Location: School of Physical Education, Sport and Exercise Science Aquatic Facility (University of Otago, Dunedin).
Supervision: Heat sessions will be supervised by an American College of Sports Medicine (ACSM) registered clinical exercise physiologist (CEP), and the PI or a research assistant; all supervising researchers are first aid trained. Attendance and heat and exercise session particulars (i.e., duration in spa, type of exercise performed etc.) will be recorded at each session by the supervising researcher.
Exposure: Participants will complete 3 heat therapy sessions per week, with bathing duration progressively increasing from 20 to 30 min, as tolerable (20 minutes first week, 25 min second week and 30 min third and subsequent weeks). Participants will be seated (or semi-recumbent) in a heated spa (39-40 °C), with water approximately top-sternal level. Following bathing, participants will complete 20-30 min of light-intensity resistance exercise (i.e., bicep curls, chest press using therabands etc.). Participants will perform a series of whole body exercises in 1 min intervals, separated with 1 min recovery.
Duration: The waitlisting period prior to arthroplasty (2-5 months; average = ~3 months) will be used for the intervention. As there is no fixed waitlisting period, the exposure duration will vary between participants.

High intensity interval training (HIIT)
Location: School of Physical Education, Sport and Exercise Science Clinical Exercise Facility (University of Otago, Dunedin).
Supervision: HIIT sessions will be supervised by an American College of Sports Medicine (ACSM) registered clinical exercise physiologist (CEP), the PI or a research assistant; all supervising researchers are first aid trained. Attendance and exercise session data (i.e., exercise heart rate) will be recorded at each session by the supervising researcher.
Exposure: HIIT will be performed 3 times a week using a cross-trainer or arm ergometer (dependent on tolerance). Each session will begin with a 5-min warm-up on an exercise modality of the participants choosing. Initial sessions will begin with 6 x 20-s intervals; interval duration will increase fortnightly to a maximum of 1 min. Exercise intensity will be set at 90% of each participants VO2peak, aiming to exceed a HR 85% of mode-specific HRpeak, with active recovery (very light intensity; 90-120 s) in between intervals. Each session will last ~30 min and include a cool-down with light-intensity, whole-body flexibility exercise.
Weeks 1-2: 6 x 20 s; 120 s recovery; 3 times per week
Weeks 3-4: 6 x 30 s; 115 s recovery; 3 times per week
Weeks 5-6: 6 x 40 s; 110 s recovery; 3 times per week
Weeks 7-8: 6 x 50 s; 100 s recovery; 3 times per week
Weeks 9+: 6 x 60 s; 90 s recovery; 3 times per week
Duration: The waitlisting period prior to arthroplasty (2-5 months; average = ~3 months) will be used for the intervention. As there is no fixed waitlisting period, the exposure duration will vary between participants.
Intervention code [1] 302017 0
Treatment: Other
Intervention code [2] 312104 0
Prevention
Comparator / control treatment
The control group will receive 'usual care'. This involves receiving advice and encouragement to eat well and stay active throughout their surgical waiting period
Control group
Active

Outcomes
Primary outcome [1] 306939 0
Peak oxygen consumption (assessed via the collection of expired gases [O2 & CO2] during cardiopulmonary exercise testing)
Timepoint [1] 306939 0
Baseline and one week pre-surgery
Secondary outcome [1] 350161 0
Body mass (assessed via digital scales)
Timepoint [1] 350161 0
Baseline, one week pre-surgery, 6 and 12 weeks post-surgery
Secondary outcome [2] 350227 0
Height (assessed via stadiometer)
Timepoint [2] 350227 0
Baseline, one week pre-surgery, 6 and 12 weeks post-surgery
Secondary outcome [3] 350228 0
Body composition (assessed via bioelectrical impedance analysis)
Timepoint [3] 350228 0
Baseline, one week pre-surgery, 6 and 12 weeks post-surgery
Secondary outcome [4] 350229 0
Muscular endurance (assessed via 30 s sit-to-stand test)
Timepoint [4] 350229 0
Baseline, one week pre-surgery, 6 and 12 weeks post-surgery
Secondary outcome [5] 350230 0
Hip joint range of motion (assessed via goniometer, only in those undergoing hip arthroplasty)
Timepoint [5] 350230 0
Baseline, one week pre-surgery, 6 and 12 weeks post-surgery
Secondary outcome [6] 350231 0
Seven day physical activity levels (assessed via accelerometry)
Timepoint [6] 350231 0
Baseline, the final week of the intervention, 6 and 12 weeks post-surgery
Secondary outcome [7] 350233 0
Resting blood pressure (assessed via auscultatory method)
Timepoint [7] 350233 0
Baseline and one week pre-surgery
Secondary outcome [8] 350234 0
Resting heart rate (assessed via electrocardiogram)
Timepoint [8] 350234 0
Baseline and one week pre-surgery
Secondary outcome [9] 350237 0
Autonomic function (assessed via heart rate variability using an ECG)
Timepoint [9] 350237 0
Baseline and one week pre-surgery
Secondary outcome [10] 350238 0
Quality of life (assessed via Short-Form 12 and EQ-5D questionnaires)
Timepoint [10] 350238 0
Baseline, one week pre-surgery, 6 and 12 weeks post-surgery
Secondary outcome [11] 350239 0
Subjective impact of knee osteoarthritis (assessed via Oxford knee score and Western Ontario and Macmaster Universities Osteoarthritis Index [WOMAC]). Composite secondary outcome.
Timepoint [11] 350239 0
Baseline, one week pre-surgery, 6 and 12 weeks post-surgery
Secondary outcome [12] 350240 0
Blood glucose regulation (assessed via 24 hour continuous blood glucose monitoring in a subset [n = 10 per group])
Timepoint [12] 350240 0
Baseline and one week pre-surgery
Secondary outcome [13] 350241 0
Postoperative Morbidity Scale
Timepoint [13] 350241 0
Documented 5 days post-surgery
Secondary outcome [14] 350242 0
Surgery Recovery Score
Timepoint [14] 350242 0
Documented 7 days post-surgery
Secondary outcome [15] 350243 0
Length of hospital stay (assessed via hospital records)
Timepoint [15] 350243 0
Documented at the time of discharge from hospital
Secondary outcome [16] 350244 0
Blood metabolic markers (HbA1c)
Timepoint [16] 350244 0
Baseline and one week pre-surgery
Secondary outcome [17] 350245 0
Haemaglobin concentration
Timepoint [17] 350245 0
Baseline and one week pre-surgery
Secondary outcome [18] 350246 0
Blood vascular adaptation markers (vascular endothelial growth factor)
Timepoint [18] 350246 0
Baseline and one week pre-surgery
Secondary outcome [19] 350247 0
Blood lipid concentration
Timepoint [19] 350247 0
Baseline and one week pre-surgery
Secondary outcome [20] 350504 0
Muscular strength (assessed via and hand-held muscle dynamometery)
Timepoint [20] 350504 0
Baseline, one week pre-surgery, 6 and 12 weeks post-surgery
Secondary outcome [21] 350505 0
Exercising blood pressure (assessed via auscultatory method)
Timepoint [21] 350505 0
Baseline and one week pre-surgery
Secondary outcome [22] 350506 0
Subjective impact of hip osteoarthritis (assessed via Oxford hip score and Western Ontario and Macmaster Universities Osteoarthritis Index [WOMAC]). Composite secondary outcome.
Timepoint [22] 350506 0
Baseline, one week pre-surgery, 6 and 12 weeks post-surgery
Secondary outcome [23] 350526 0
Knee joint range of motion (assessed via goniometer, only in those undergoing knee arthroplasty)
Timepoint [23] 350526 0
Baseline, one week pre-surgery, 6 and 12 weeks post-surgery

Eligibility
Key inclusion criteria
- Patient meets the threshold for elective primary arthroplasty at Dunedin Public Hospital;
- Patient gives written consent;
- Patient is able to travel to the study centre to complete all sessions.
Minimum age
18 Years
Maximum age
No limit
Gender
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.);
- Revision arthroplasty;
- Upper-limb pathology that limits upper-limb exercise, e.g., shoulder-joint osteoarthritis;
- Heat intolerance;
- Any other medical condition deemed a significant risk to study participation.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be performed by a colleague independant of the study using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A colleague independant of the study will allocate randomisation using a computer-generated list involving block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We have used data from a pilot study of preoperative HIIT in general surgery patients to conduct a power analysis. A sample size of 27 patients per group (81 total) is required to achieve an 80% probability of detecting a 2.0 ml.kg-1.min-1 difference in VO2peak at follow-up, if the type I error rate is controlled at 5%. Data on attrition rates from previous exercise intervention studies in arthritis cohorts is limited, but range 0-18%. Furthermore, recent intervention studies from our lab on heat therapy in PAD patients and HIIT in general surgery patients had attrition rates of 0% and ~ 20% respectively. We are minimising barriers to participation (i.e., transport reimbursement, direct supervision during all intervention sessions) and researchers will be promoting the benefits of study participation, therefore anticipate participant attrition of 10% and will recruit 30 participants per group (90 total).

An analysis of covariance (ANCOVA), using baseline fitness and number of intervention sessions as the covariate will test for significant differences in variables, between baseline and follow-up preoperatively. Non-parametric testing will test for significant differences between groups for the SRS and LOS. Differences between groups in postoperative mortality, morbidity and complication rates will be tested using the chi-square test or with Fisher’s exact test. A significance level of 0.05 will be used for all tests. Data on session attendance will be kept for compliance and participant’s data analysed if they meet a 90% compliance rate.

Recruitment
Recruitment status
Not yet recruiting
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 outside Australia
Country [1] 10719 0
New Zealand
State/province [1] 10719 0
Otago

Funding & Sponsors
Funding source category [1] 300284 0
Government body
Name [1] 300284 0
Health Research Council
Address [1] 300284 0
PO Box 5541, Wellesley Street, Auckland 1141
Country [1] 300284 0
New Zealand
Funding source category [2] 300289 0
University
Name [2] 300289 0
University of Otago - Department of Surgical Sciences
Address [2] 300289 0
Department of Surgical Sciences
Dunedin School of Medicine
PO Box 913
Dunedin 9054
Country [2] 300289 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] 299713 0
Individual
Name [1] 299713 0
Brendon Roxburgh
Address [1] 299713 0
Department of Surgical Sciences
Dunedin School of Medicine
PO Box 913
Dunedin 9054
Country [1] 299713 0
New Zealand
Other collaborator category [1] 280270 0
Individual
Name [1] 280270 0
Prof. Jim Cotter
Address [1] 280270 0
School of Physical Education, Sport and Exercise Sciences
University of Otago
46 Union St West
PO Box 913
Dunedin 9054
Country [1] 280270 0
New Zealand
Other collaborator category [2] 280271 0
Individual
Name [2] 280271 0
Assoc Prof. David Gwynne-Jones
Address [2] 280271 0
Department of Surgical Sciences
Dunedin School of Medicine
PO Box 913
Dunedin 9054
Country [2] 280271 0
New Zealand
Other collaborator category [3] 280272 0
Individual
Name [3] 280272 0
Prof. Andre van Rij
Address [3] 280272 0
Department of Surgical Sciences
Dunedin School of Medicine
PO Box 913
Dunedin 9054
Country [3] 280272 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 301094 0
Health and Disability Ethics Committee
Ethics committee address [1] 301094 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 301094 0
New Zealand
Date submitted for ethics approval [1] 301094 0
13/08/2018
Approval date [1] 301094 0
Ethics approval number [1] 301094 0

Summary
Brief summary
Previous research has shown those with higher fitness levels, have better cardiovascular health, and following surgery they have fewer complications and recover faster. However, only one study has investigated if improving an individual’s fitness level prior to surgery, translates to better outcomes following surgery. In the months prior to surgery, participants will perform heat therapy or upper-limb high intensity interval training 3 times per week, aiming to improve preoperative fitness. We predict that by increasing fitness before surgery, patients will improve their cardiovascular and metabolic health, have a shorter stay in hospital and an improved recovery after surgery. The logical assumption is that this will translate to significant cost savings for the health care system. We hope the findings from this research lead to a significant change in clinical practice, ensuring patients are more active prior to various types of surgeries. Due to the nature of this research, the findings could be quickly and easily implemented in to everyday practice, ensuring better patient care and outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85866 0
Dr Kate Thomas
Address 85866 0
Department of Surgical Sciences
Dunedin School of Medicine
PO Box 913
Dunedin 9054
Country 85866 0
New Zealand
Phone 85866 0
+64 34709852
Fax 85866 0
Email 85866 0
kate.thomas@otago.ac.nz
Contact person for public queries
Name 85867 0
Dr Kate Thomas
Address 85867 0
Department of Surgical Sciences
Dunedin School of Medicine
PO Box 913
Dunedin 9054
Country 85867 0
New Zealand
Phone 85867 0
+64 34709852
Fax 85867 0
Email 85867 0
kate.thomas@otago.ac.nz
Contact person for scientific queries
Name 85868 0
Dr Kate Thomas
Address 85868 0
Department of Surgical Sciences
Dunedin School of Medicine
PO Box 913
Dunedin 9054
Country 85868 0
New Zealand
Phone 85868 0
+64 34709852
Fax 85868 0
Email 85868 0
kate.thomas@otago.ac.nz

No data has been provided for results reporting
Summary results
Not applicable