Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001358235
Ethics application status
Approved
Date submitted
8/08/2018
Date registered
13/08/2018
Date last updated
28/04/2022
Date data sharing statement initially provided
3/04/2019
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, HIIT & Home 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
Participants will be randomised to either heat therapy or HIIT of the intervention groups outlined below, and perform this intervention only. If they have not been scheduled for their surgery following the 12 week intervention, all participants will completed the Home-based maintenance phase for 12 weeks or, shorter if their surgery is scheduled before this time.

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: Participants will complete 12 weeks of heat therapy.

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, arm ergometer and / or cycle (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 60-s intervals, with recovery (90-120 s) in between intervals. Interval duration will remain constant throughout the intervention, with the aim of increasing the number of intervals to 8 and recovery duration decreasing to 60 sec, based on participant progress. Exercise intensity will initially be set at 85% of each participants VO2peak, before increasing each interval until a score of 7/10 on the rating of perceived exertion (RPE) scale is achieved; this corresponding workload will be used for subsequent intervals. As fitness increases, workload will increase to maintain this RPE,. Each session will last ~30 min and include a cool-down with light-intensity, whole-body flexibility exercise.
Duration: Participants will complete 12 weeks of upper-limb HIIT.

Home-based maintenance phase
Location: At the participant’s home, preferred exercise facility or in the community.
Supervision: Home-based maintenance sessions will be unsupervised. A registered CEP will design a personalised exercise programme and all participants will be educated on how to perform it safely and effectively. Participants will record a log of daily step count.
Exposure: The personalised exercise programme will be based on the participant’s fitness, joint pain levels and their access to exercise equipment / facilities. The training regimen will follow ACSM recommendations for aerobic exercise in those with osteoarthritis, which recommend accumulating at least 150 minutes of activity each week. All participants will be provided an RPE scale and instructed to progress exercise intensity to a limit of 5/10 (i.e., “Hard”), and avoid excessive increases in acute joint pain. Where a participant has no access to exercise equipment / facilities, a pedometer will be provided; advice will be to steadily increase daily step count (determined from 12-week reassessment) by 10% every 4 weeks.
Duration: The maintenance phase will last for 12 weeks or until one week prior to surgery (whichever is sooner).
Intervention code [1] 302017 0
Treatment: Other
Intervention code [2] 312104 0
Prevention
Comparator / control treatment
Home-based exercise
Location: The participants home or exercise location of their choosing.
Supervision: Participants will initially be taken through their home-based exercise programme by an ACSM registered CEP, the PI or a research assistant, who will demonstrate and explain how to perform the exercise safely. A supervising researcher will provide fortnightly phone calls to provide support and answer any questions. Participants will record via an exercise log details (i.e., number of repetitions) about the exercises they perform.
Exposure: Home-based exercise sessions will be performed 3 times per week. Participants will perform 9 different strength and flexibility exercises, initially aiming for 2 sets of 8 repetitions per exercise; this will progress as their strength increases. A resistance band will also be provided to be used for some exercises. Each session will last 15-30 minutes.
Duration: Participants will complete 12 weeks of home-based exercise. If still awaiting surgery after 12 weeks, they will continue with the home-based maintenance programme.
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, 12-weeks and end of home-based maintenance phase.
Secondary outcome [1] 350161 0
Body mass (assessed via digital scales)
Timepoint [1] 350161 0
Baseline, 12-weeks, end of home-based maintenance phase and 6-weeks post-surgery.
Secondary outcome [2] 350227 0
Height (assessed via stadiometer)
Timepoint [2] 350227 0
Baseline, 12-weeks, end of home-based maintenance phase and 6-weeks post-surgery.
Secondary outcome [3] 350228 0
Body composition (assessed via bioelectrical impedance analysis)
Timepoint [3] 350228 0
Baseline, 12-weeks, end of home-based maintenance phase and 6-weeks post-surgery.
Secondary outcome [4] 350229 0
Muscular endurance (assessed via 30 s sit-to-stand and 30 s arm curl test)
Timepoint [4] 350229 0
Baseline, 12-weeks, end of home-based maintenance phase and 6-weeks post-surgery.
Secondary outcome [5] 350231 0
Seven day physical activity levels (assessed via accelerometry)
Timepoint [5] 350231 0
Baseline, 12-weeks, end of home-based maintenance phase and 6-weeks post-surgery.
Secondary outcome [6] 350233 0
Resting blood pressure (assessed via auscultatory method)
Timepoint [6] 350233 0
Baseline, 12-weeks, end of home-based maintenance phase and 6-weeks post-surgery.
Secondary outcome [7] 350234 0
Resting heart rate (assessed via electrocardiogram)
Timepoint [7] 350234 0
Baseline, 12-weeks and end of home-based maintenance phase..
Secondary outcome [8] 350237 0
Autonomic function (assessed via heart rate variability using an ECG)
Timepoint [8] 350237 0
Baseline, 12-weeks and end of home-based maintenance phase..
Secondary outcome [9] 350238 0
Quality of life (assessed via Short-Form 12 and EQ-5D questionnaires)
Timepoint [9] 350238 0
Baseline, 12-weeks, end of home-based maintenance phase and 6-weeks post-surgery.
Secondary outcome [10] 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 [10] 350239 0
Baseline, 12-weeks, end of home-based maintenance phase and 6-weeks post-surgery.
Secondary outcome [11] 350240 0
Blood glucose regulation (assessed via 7 day continuous blood glucose monitoring in a subset [n = 10 per group])
Timepoint [11] 350240 0
Baseline and 12-weeks.
Secondary outcome [12] 350241 0
Postoperative Morbidity Scale
Timepoint [12] 350241 0
Documented 3 days post-surgery
Secondary outcome [13] 350242 0
Surgery Recovery Score
Timepoint [13] 350242 0
Documented 7 days and 6-weeks post-surgery.
Secondary outcome [14] 350243 0
Length of hospital stay (assessed via hospital records)
Timepoint [14] 350243 0
Documented at the time of discharge from hospital
Secondary outcome [15] 350244 0
Blood metabolic markers (HbA1c)
Timepoint [15] 350244 0
Baseline, 12-weeks, and end of home-based maintenance phase.
Secondary outcome [16] 350246 0
Blood vascular adaptation markers (vascular endothelial growth factor)
Timepoint [16] 350246 0
Baseline, 12-weeks, and end of home-based maintenance phase.
Secondary outcome [17] 350247 0
Blood lipid concentration
Timepoint [17] 350247 0
Baseline, 12-weeks, and end of home-based maintenance phase.
Secondary outcome [18] 350504 0
Muscular strength (assessed via and hand-held muscle dynamometery)
Timepoint [18] 350504 0
Baseline, 12-weeks, end of home-based maintenance phase and 6-weeks post-surgery.
Secondary outcome [19] 350505 0
Exercising blood pressure (assessed via auscultatory method)
Timepoint [19] 350505 0
Baseline, 12-weeks and end of home-based maintenance phase.
Secondary outcome [20] 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 [20] 350506 0
Baseline, 12-weeks, end of home-based maintenance phase and 6-weeks post-surgery.
Secondary outcome [21] 350526 0
Knee joint range of motion (assessed via goniometer, only in those undergoing knee arthroplasty)
Timepoint [21] 350526 0
Baseline, 12-weeks, end of home-based maintenance phase and 6-weeks post-surgery.
Secondary outcome [22] 374157 0
Anaerobic threshold (assessed via the collection of expired gases [O2 & CO2] during cardiopulmonary exercise testing)
Timepoint [22] 374157 0
Baseline, 12-weeks and end of home-based maintenance phase.
Secondary outcome [23] 374158 0
Acute hypotensive response to heat / HIIT (difference is pre-intervension and post-intervention session blood pressure; assessed via auscultatory method).
Timepoint [23] 374158 0
First intervention session
Secondary outcome [24] 374159 0
DASI questionnaire
Timepoint [24] 374159 0
Baseline, 12-weeks, end of home-based maintenance phase and 6-weeks post-surgery.
Secondary outcome [25] 374160 0
Time to use one crutch (assessed via follow-up phone call)
Timepoint [25] 374160 0
Post-surgery
Secondary outcome [26] 374161 0
Time to use no crutches (assessed via follow-up phone call)
Timepoint [26] 374161 0
Post-surgery
Secondary outcome [27] 374162 0
Blood inflammatory cytokines (exploratory outcome)
Timepoint [27] 374162 0
Baseline, 12-weeks and end of home-based maintenance phase.
Secondary outcome [28] 374163 0
24 h accelerometry
Timepoint [28] 374163 0
24 h prior and 24 h post, first and final intervention sessions
Secondary outcome [29] 409164 0
Physical function (assessed via timed up and go test)
Timepoint [29] 409164 0
Baseline, 12-weeks, end of home-based maintenance phase and 6-weeks post-surgery.

Eligibility
Key inclusion criteria
- Patient meets the threshold for elective primary arthroplasty at Dunedin Public Hospital or is expected to meet the threshold within the next year;
- Patient has radiographic evidence of severe OA (Kellgren Lawrence grade 3 or 4);
- 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
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.);
- Revision arthroplasty;
- Charnley C type patients
- Staged bilateral total joint replacement
- 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).

Statistical analysis will be performed using SPSS (v23.0, IBM, USA) and Prism (v7.0, GraphPad, USA). The D’Agostino and Pearson omnibus test will be used to test for normality of the data. Normally distributed data will be expressed as mean ? standard deviation and non-parametric data expressed as median and interquartile range (25th to 75th percentile). Between-group differences in baseline variables will be assessed using a one-way analysis of variance (ANOVA). An analysis of covariance (ANCOVA), using baseline fitness and number of intervention sessions as the covariate will test for significant between-group differences in baseline and 12-week follow-up primary (i.e., VO2peak) and secondary (i.e., other CPET, cardiovascular, metabolic, anthropometric, functional and qualitative) variables. A dependent t-test will test for significant differences in 12-week follow-up and post home-based maintenance phase variables. A dependent t-test will compare preoperative variables with variables measured at 6-weeks postoperatively. Non-parametric testing will test for significant differences between nonnormally distributed variables. Categorical data (i.e., SRS and POMs) will be analysed using the Chi-square test or with Fisher’s exact test. A significance level of 0.05 will be used for all tests.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/09/2019
Actual
2/09/2019
Date of last participant enrolment
Anticipated
30/10/2020
Actual
27/04/2021
Date of last data collection
Anticipated
29/01/2021
Actual
14/10/2021
Sample size
Target
90
Accrual to date
Final
93
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
Country [1] 300284 0
New Zealand
Funding source category [2] 300289 0
University
Name [2] 300289 0
University of Otago - Department of Surgical Sciences
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
Approved
Ethics committee name [1] 301094 0
Health and Disability Ethics Committee
Ethics committee address [1] 301094 0
Ethics committee country [1] 301094 0
New Zealand
Date submitted for ethics approval [1] 301094 0
13/08/2018
Approval date [1] 301094 0
31/10/2018
Ethics approval number [1] 301094 0
18/NTA/148

Summary
Brief summary
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
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
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

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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAcute and adaptive cardiovascular and metabolic effects of passive heat therapy or high-intensity interval training in patients with severe lower-limb osteoarthritis.2023https://dx.doi.org/10.14814/phy2.15699
N.B. These documents automatically identified may not have been verified by the study sponsor.