Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000655246
Ethics application status
Approved
Date submitted
19/04/2018
Date registered
24/04/2018
Date last updated
8/04/2019
Date data sharing statement initially provided
8/04/2019
Date results information initially provided
8/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of high versus low intensity exercise for symptoms of knee and hip osteoarthritis
Scientific title
Effect of high intensity resistance and impact training on symptoms of knee and hip osteoarthritis: the MOAST trial
Secondary ID [1] 294291 0
None
Universal Trial Number (UTN)
Trial acronym
MOAST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 306985 0
Condition category
Condition code
Musculoskeletal 306080 306080 0 0
Osteoarthritis
Public Health 306081 306081 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High intensity progressive resistance and impact loading exercise program (HiRIT)

- Two training sessions of 30-40 minutes per week on non-consecutive days for 6 months 
- Group exercise program with a maximum of 8 participants per class and trainer, led by an experienced instructor (the instructor is either an exercise scientist trained in power lifting or an exercise physiologist)
- The program consists of three weight lifting exercises and one impact exercise
- Load and intensity of the lifting and impact exercise are gradually and individually increased
- Five sets of five repetitions at 80-85% 1RM are performed for each of the three lifting exercises

- The classes take place at The Bone Clinic, Coorparoo, Brisbane, QLD 
- Adherence is tracked by the instructor and the study participants. Participants are given an exercise diary to report the sessions attended, weights lifted, any muscle soreness, injuries, falls and changes in medication, which the instructor monitors.
Intervention code [1] 300588 0
Lifestyle
Comparator / control treatment
Home exercise program

- Three sessions of approximately 20 minutes per week on non-consecutive days for 6 months 
- The home exercise program is carried out unsupervised at home
- The program includes resistance, balance, impact and mobility training
- To assess adherence, participants are given an exercise diary to report the sessions completed, any muscle soreness, injuries, falls and changes in medication.
Control group
Active

Outcomes
Primary outcome [1] 305116 0
Change in osteoarthritis symptoms: pain, stiffness and physical function (WOMAC score)
Timepoint [1] 305116 0
6 months post-enrolment
Primary outcome [2] 305117 0
Change in osteoarthritis pain (ICOAP score)
Timepoint [2] 305117 0
6 months post-enrolment
Secondary outcome [1] 344218 0
BMC at the total hip (DXA)
Timepoint [1] 344218 0
6 months post-enrolment
Secondary outcome [2] 344219 0
aBMD at the total hip (DXA)
Timepoint [2] 344219 0
6 months post-enrolment
Secondary outcome [3] 344220 0
BMC at the femoral neck (DXA)
Timepoint [3] 344220 0
6 months post-enrolment
Secondary outcome [4] 344221 0
aBMD at the femoral neck (DXA)
Timepoint [4] 344221 0
6 months post-enrolment
Secondary outcome [5] 344222 0
BMC at the lumbar spine, L2-L4 (DXA)
Timepoint [5] 344222 0
6 months post-enrolment
Secondary outcome [6] 344223 0
aBMD at the lumbar spine, L2-L4 (DXA)
Timepoint [6] 344223 0
6 months post-enrolment
Secondary outcome [7] 344224 0
Whole body BMC (DXA)
Timepoint [7] 344224 0
6 months post-enrolment
Secondary outcome [8] 344225 0
Whole body aBMD (DXA)
Timepoint [8] 344225 0
6 months post-enrolment
Secondary outcome [9] 344226 0
Lean mass (DXA)
Timepoint [9] 344226 0
6 months post-enrolment
Secondary outcome [10] 344227 0
Fat mass (DXA)
Timepoint [10] 344227 0
6 months post-enrolment
Secondary outcome [11] 344228 0
Mobility (timed up-and-go test)
Timepoint [11] 344228 0
6 months post-enrolment
Secondary outcome [12] 344229 0
Balance (functional reach test)
Timepoint [12] 344229 0
6 months post-enrolment
Secondary outcome [13] 344230 0
Dynamic balance (tandem walk test)
Timepoint [13] 344230 0
6 months post-enrolment
Secondary outcome [14] 344231 0
Back extensor strength (handheld dynamometer)
Timepoint [14] 344231 0
6 months post-enrolment
Secondary outcome [15] 344232 0
Lower extremity function (five times sit-to-stand test)
Timepoint [15] 344232 0
6 months post-enrolment
Secondary outcome [16] 344233 0
Posture/kyphosis (standing tragus to wall distance measure)
Timepoint [16] 344233 0
6 months post-enrolment
Secondary outcome [17] 344234 0
Posture/kyphosis (measure of degree of thoracic deformity using an inclinometer in relaxed and erect standing)
Timepoint [17] 344234 0
6 months post-enrolment
Secondary outcome [18] 344237 0
Physical activity enjoyment (PACES questionnaire)
Timepoint [18] 344237 0
6 months post-enrolment
Secondary outcome [19] 344238 0
Safety: number of adverse events (questionnaire specifically designed for this study)
Timepoint [19] 344238 0
6 months post-enrolment
Secondary outcome [20] 344239 0
Adherence: Number of exercise sessions attended (diaries)
Timepoint [20] 344239 0
6 months post-enrolment

Eligibility
Key inclusion criteria
- Apparently healthy men and women
- Age 50+ years
- Hip or knee osteoarthritis based on medical records and/or on results from the WOMAC questionnaire. Participants were eligible if they scored at least one item in two different subdomains of WOMAC with a 2 (moderate symptoms)
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- walking aids
- malignancy or receiving radiation or chemotherapy
- current regular physical activity that includes strength training or intention to start any kind of exercise program during the 6-month study period
- medications known to affect bone health (e.g. bisphosphonates, denosumab, hormone therapy, vitamin D injections)
- conditions know to influence bone health (e.g. Paget’s disease)
- conditions prevention completion of either exercise program (e.g. spinal cord injury, nerve disorder, uncontrolled cardiovascular disease)
- inability or unwillingness to attend the supervised training program or the home program if assigned
- planned absence (e.g. holidays) of more than two weeks during the 6-month study period.
- three or more ionising radiation exposures in the previous 12 months (exceptions apply see below)
Participants who have had three or more x-ray examinationionising radiation exposures in the previous 12 months and wish to volunteer for the study regardless before enrolmentmust have to si sign an additional consent formstatement, confirming that they recognise and consent to the requirement agree to undergo baseline and follow-up DXA scanning in spite of other recent ionising radiation-based scanning exposure

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)
Allocation is not concealed but study hypotheses are not disclosed with respects to the expected most efficacious exercise program
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified block randomisation using a randomisation table created by computer software. Stratification variables were sex (male, female), age (50-64 years, 65+ years), joint(s) with most severe OA (knee, hip)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analyses will be performed using SPSS statistical software. In all analyses a p-value of 0.05 (two-sided) will be considered a threshold for statistical significance.
Descriptive analyses will be run for participant characteristics and biometrics. Repeated measures ANCOVA will be conducted to examine treatment effects on all outcome variables adjusting for any variables that differ between groups at baseline. Intention-to-treat analyses will be conducted along with per-protocol analyses to examine specific outcomes of participants completing the full 6 months of training with at least 80% compliance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/05/2016
Date of last participant enrolment
Anticipated
Actual
8/12/2017
Date of last data collection
Anticipated
11/06/2018
Actual
11/06/2018
Sample size
Target
70
Accrual to date
Final
74
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 22030 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 298937 0
University
Name [1] 298937 0
Griffith University
Country [1] 298937 0
Australia
Funding source category [2] 299274 0
Commercial sector/Industry
Name [2] 299274 0
The Bone Clinic
Country [2] 299274 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
58 Parklands Dr, Southport QLD 4215
Country
Australia
Secondary sponsor category [1] 298149 0
Commercial sector/Industry
Name [1] 298149 0
The Bone Clinic
Address [1] 298149 0
26 Turbo Drive Coorparoo QLD 4151
Country [1] 298149 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299873 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 299873 0
Human Research Ethics Committee
Level 0, Bray Centre (N54)
Griffith University
170 Kessels Road
Nathan Qld 4111
Ethics committee country [1] 299873 0
Australia
Date submitted for ethics approval [1] 299873 0
15/03/2016
Approval date [1] 299873 0
21/04/2016
Ethics approval number [1] 299873 0
2016/187

Summary
Brief summary
Osteoarthritis (OA) of the knee and the hip is an important health issue in the senior population since it causes chronic pain, reduces physical functioning and has a negative effect on quality of life. Different types of exercise intervention programs have shown a beneficial effect on OA symptoms. However, only few studies tested the effect of high load resistance training in OA patients. Observational data from The Bone Clinic suggests that our bone exercise program, consisting of high load resistance training plus impact weight bearing is not only beneficial for bone but also for OA symptoms. This study aims to formally test the effect of our bone exercise program in combination with balance exercises on pain, physical function and quality of life in people with knee or hip OA.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81830 0
Prof Belinda Beck
Address 81830 0
Griffith University Gold Coast
58 Parklands Dr, Southport QLD 4215
Country 81830 0
Australia
Phone 81830 0
+61 7 5552 8793
Fax 81830 0
Email 81830 0
b.beck@griffithu.edu.au
Contact person for public queries
Name 81831 0
Prof Belinda Beck
Address 81831 0
Griffith University Gold Coast
58 Parklands Dr, Southport QLD 4215
Country 81831 0
Australia
Phone 81831 0
+61 7 5552 8793
Fax 81831 0
Email 81831 0
melanie.fischbacher@griffithuni.edu.au
Contact person for scientific queries
Name 81832 0
Prof Belinda Beck
Address 81832 0
Griffith University Gold Coast
58 Parklands Dr, Southport QLD 4215
Country 81832 0
Australia
Phone 81832 0
+61 7 5552 8793
Fax 81832 0
Email 81832 0
melanie.fischbacher@griffithuni.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
HREC approval does not include sharing of IPD


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1821Informed consent form    374693-(Uploaded-08-04-2019-13-36-43)-Study-related document.pdf
1822Ethical approval    374693-(Uploaded-08-04-2019-13-37-07)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.