Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000273482
Ethics application status
Approved
Date submitted
25/02/2016
Date registered
1/03/2016
Date last updated
1/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility and potential benefits of high-intensity interval cycling for knee osteoarthritic patients: a randomised control feasibility trial?
Scientific title
Is high-intensity interval cycling feasible and more beneficial than continuous cycling for knee osteoarthritic patients: a randomised control feasibility trial?
Secondary ID [1] 288631 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 297789 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297974 297974 0 0
Other physical medicine / rehabilitation
Musculoskeletal 297993 297993 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomised control trial study was conducted to gain some preliminary data on the feasibility and efficacy of high-intensity interva;l training (HIIT) vs moderate intensity continuous training (MICT) cycling for improving measures of body composition, physical function and disability in middle-aged and older knee OA patients. It was hypothesised that both forms of home-based exercise would be feasible and produce a range of functional and health benefits.
The participants were requested to perform four cycle sessions per week over the course of eight weeks, with each session lasting approximately 25 minutes. As a home-based intervention, there was no supervsion of the exercise sessions or quantitative assessment of exercise intensity performed by either group. The cycling program for the moderate intensity continuous training (MICT) group commenced with a 3 minute warm-up at a light intensity, followed by 20 minutes at a moderate intensity in which the participant was encouraged to cycle between 60-80 rpm at an appropriate workload and then to finish the training session with a 2 minute cool-down at a light intensity. Moderate intensity was defined as being “able to speak in complete sentences during the exercise. If you find yourself getting too ”puffed” or out of breath - slow down a little”. For those in the high-intensity interval training (HIIT) group, their training sessions commenced with a 7 minute warm-up of gradually increasing intensity and concluded with a 6 to 7 minute cool-down of light to moderate cycling. The HIIT component of the training session involved five series, with each series commencing with 45 s at a moderately high to high intensity followed by 90 s at moderately low intensity. For the 45 second high-intensity bouts, the participants were requested to cycle at a higher cadence (70-90 rpm) and resistance than they used in the 90 s recovery bouts, with the intensity of the high-intensity bouts being described as “an intensity at which you felt it was quite difficult to complete sentences during the exercise”.
To monitor adherence, participants completed a training diary in which they stated the dates they performed exercise each week; with the explicit aim provided to the participants being to perform four sessions per week over the course of the eight week trial.
Intervention code [1] 294038 0
Rehabilitation
Intervention code [2] 294057 0
Treatment: Other
Comparator / control treatment
The MICT group will act as the comparator group.
Control group
Active

Outcomes
Primary outcome [1] 297495 0
Feasibility of both home-based (MICT and HIIT) exercise programs was assessed by quantifying the adherence rate, dropout rate and number of adverse events. Adherence rate was assessed by review of the participants training diaries at the end of the intervention, and calculated by dividing the number of completed training sessions by the requested number of training sessions (n = 32), and expressed as a percentage. Dropout rates (also expressed as a percentage) were calculated by dividing the number of participants who failed to complete post-testing by the number of participants who completed baseline testing. Adverse effects was assessed by review of participants' adverse effects diary, with adverse effects defined as “an exercise-induced change that worsens an aspect of your condition that is greater than the expected day-to-day variation”. Participants were especially advised to note adverse effects including muscle soreness, knee pain or any cardiovascular complications.
Timepoint [1] 297495 0
Collected throughout the 8 weeks of training
Secondary outcome [1] 321210 0
WOMAC: The severity of knee OA was assessed by the WOMAC which is a 24 item OA health status questionnaire that assesses the patient’s degree of pain, stiffness and physical functional ability. Each of the 24 questions is graded on a five-point Likert scale from none (0), mild (1), moderate (2), severe (3) and extreme (4) that assesses the patient’s degree of difficulty when performing a range of activities of daily living. The maximum score obtainable is 96.
Timepoint [1] 321210 0
Post 8 weeks training
Secondary outcome [2] 321271 0
Lequesne index of severity for osteoarthritis of the knee: The Lequesne index is a disease-specific questionnaire comprising of 11 items that assess the patient’s perspective of their pain/discomfort, maximum walking distance with or without walking aids and physical function/disability. The score for each item is summed, with the maximum possible score being 24. Higher scores indicate decreased health, with the severity of the disability being described as small (1-4), intermediate (5-7), serious (8-10), very serious (11-13) and extremely serious (> 13).
Timepoint [2] 321271 0
Post 8 weeks training
Secondary outcome [3] 321272 0
Sit to stand (STS): The STS was used to assess the participants lower extremity strength and function, with the validity and reliability of this measure demonstrated in previous studies. The test was performed on a straight-backed, armless chair that was 43cm in height. Participants were asked to sit on the chair and keep their arms crossed across the chest throughout the test. On the word ‘go’, participants stood up and sat down as many times as possible in 30 seconds. Participants were allowed one practice trial in which they performed ~3-4 repetitions at a submaximal intensity. Due to the fatigue associated with this test, only one trial was performed.
Timepoint [3] 321272 0
Post 8 weeks training
Secondary outcome [4] 321273 0
Timed Up and Go (TUG): The TUG test is a valid and reliable measure of functional mobility in a range of older adult populations, in which the participants were asked to stand up from a 43 cm high, armless chair and then proceed to walk around a cone 3 m away before sitting back on the chair. The following instructions were given “stand-up and walk around the flagpole and sit back down on the chair at a pace comfortable for you”. Participants were allowed one practice trial, with the best time from three timed trials used for analysis.
Timepoint [4] 321273 0
Post 8 weeks training
Secondary outcome [5] 321274 0
Habitual gait speed: Habitual gait speed was quantified using the GaitMat II pressure mat system (Manufacturer is EQInc; Model is GaitMat II) 25. The following instructions were given, “Walk towards the end of the room at a pace that is comfortable for you”. All trials were initiated 2 m (6.56 ft.) before the GaitMat II platform (3.66 m long) and finished 2 m after the GaitMat II so to reduce the potential effect of acceleration and deceleration on the mean gait speed 26. The average gait speed from three attempts was used for data analysis.
Timepoint [5] 321274 0
Post 8 weeks training
Secondary outcome [6] 321275 0
Body composition: Body composition was assessed using the Tanita MC–980MA body composition analyser. The Tanita MC-980MA indirectly assesses body composition (muscle and fat mass) via the bioelectric impedance assessment (BIA) method. As the BIA method is sensitive to alteration is in hydration, all participants were requested to be normally hydrated and to have not even for a period of two hours before the BIA assessment. To determine the body composition, participants were asked to stand motionless in bare feet on the Tanita MC–980MA platform while holding the handles for a period of 30 s, during which time a very small electric current was transmitted through their body. The sensitivity of this device was 0.1 kg for total body mass, muscle mass and fat mass.
Timepoint [6] 321275 0
Post 8 weeks training

Eligibility
Key inclusion criteria
A confirmed diagnosis of knee osteoarthritis by an orthopaedic surgeon; were provided clearance by their physician to participate in the study and who were unlikely to change their osteoarthritic management during the course of the study were eligible to participate.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any other chronic diseases that pose contraindications for performing a home-based home exercise program e.g. unstable cardiac conditions; not having access to a stationary bicycle to perform the home-based program.

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)
The lead investigator who did not interact with the participants in relation to their assessments used a computer-generated randomisation sequence (see below) and provided this to the research assistant who gave the participants their allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of participants to either of two groups was performed via https://www.random.org/
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Centrality and dispersion of the continuous data was reported as means and standard deviations, whereas categorical measures were reported as number and percentage. Within-group changes were analysed with a two tail paired t-test; with between group changes analysed for two tail independent t-test with unequal variance. All statistical analyses will be performed in SPSS or Microsoft Excel 2010, with statistical significance set at p = 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/05/2014
Date of last participant enrolment
Anticipated
Actual
17/11/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 292989 0
Self funded/Unfunded
Name [1] 292989 0
Country [1] 292989 0
Primary sponsor type
University
Name
Bond University
Address
14 University Drv
Robina
QLD 4229
Country
Australia
Secondary sponsor category [1] 291761 0
None
Name [1] 291761 0
Address [1] 291761 0
Country [1] 291761 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294497 0
Bond University Research Ethics Committee
Ethics committee address [1] 294497 0
Ethics committee country [1] 294497 0
Australia
Date submitted for ethics approval [1] 294497 0
18/11/2013
Approval date [1] 294497 0
07/01/2014
Ethics approval number [1] 294497 0
RO1776

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63914 0
A/Prof Justin Keogh
Address 63914 0
Faculty of Health Sciences and Medicine
Bond university
14 University Drv
Robina
QLD 4229
Country 63914 0
Australia
Phone 63914 0
+617 5595 4487
Fax 63914 0
Email 63914 0
[email protected]
Contact person for public queries
Name 63915 0
Justin Keogh
Address 63915 0
Faculty of Health Sciences and Medicine
Bond university
14 University Drv
Robina
QLD 4229
Country 63915 0
Australia
Phone 63915 0
+617 5595 4487
Fax 63915 0
Email 63915 0
[email protected]
Contact person for scientific queries
Name 63916 0
Justin Keogh
Address 63916 0
Faculty of Health Sciences and Medicine
Bond university
14 University Drv
Robina
QLD 4229
Country 63916 0
Australia
Phone 63916 0
+617 5595 4487
Fax 63916 0
Email 63916 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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIs home-based, high-intensity interval training cycling feasible and safe for patients with knee osteoarthritis?: Study protocol for a randomized pilot study.2017https://dx.doi.org/10.1177/2325967117694334
N.B. These documents automatically identified may not have been verified by the study sponsor.