Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001224718
Ethics application status
Approved
Date submitted
5/11/2013
Date registered
6/11/2013
Date last updated
6/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of a bout of resistance exercise on pressure pain sensitivity in knee osteoarthritis
Scientific title
Does a bout of resistance exercise evoke an analgesic response in individuals with knee osteoarthritis and young and old healthy individuals
Secondary ID [1] 283499 0
Nil
Universal Trial Number (UTN)
U1111-1149-9258
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 290417 0
Condition category
Condition code
Musculoskeletal 290808 290808 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single bout of resistance exercise (i.e. strength training) comprising 3 exercise, 3 sets of 10 repetitions at 60% of maximum (i.e. 60% of 1 repetition maximum), 1 minute rest between sets. This intervention was delivered under 2 conditions, either 3 lower body exercises (leg press, leg curl, calf raise) or 3 upper body exercises (chest press, supported row, lat pulldown). Upper and lower body exercise bouts were completed separately with 1 week washout in between bouts.
Intervention code [1] 288205 0
Treatment: Other
Comparator / control treatment
This study will examine pain sensitivity pre and post-exercise therefore the participants' baseline measures will act as their own controls for comparison with each of lower body and upper body exercise. There are 3 groups of participants, one group diagnosed with knee osteoarthritis, 1 old healthy group (50+ yrs) and 1 young healthy group (18-35).
Control group
Active

Outcomes
Primary outcome [1] 290803 0
Pressure pain threshold will be assessed via a force algometer, which measure pressure through a rubber tip. This pressure will be slowly increased until the participant indicates they feel pain.
Timepoint [1] 290803 0
Baseline and immediately post exercise
Secondary outcome [1] 305331 0
Pressure pain tolerance will be assessed via a novel device that will place a constant pressure (at 90% of their threshold) on the medial aspect of a participant's knee. This pressure will be maintained for 5 min or until the participant can no longer tolerate the pain. Pain ratings will be taken every 30 sec via a 0-10 pain scale.
Timepoint [1] 305331 0
Baseline and immediately post exercise

Eligibility
Key inclusion criteria
Any individual diagnosed with knee osteoarthritis by a general practitioner or rheumatologist (i.e. osteoarthritis group).
For the healthy control groups, young (18-35) and older (50 and older) people who are unaffected by osteoarthritis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
A history of chronic pain or musculoskeletal or neuromuscular disorders with the exception of osteoarthritis of one or both knees only (osteoarthritis of other joints will mean exclusion). Any absolute or uncontrolled cardiovascular contraindications

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)
Participants will be recruited via posters placed at the university and in the reception areas of various gyms and exercise physiology clinics. The onus will be on potential participants to approach researchers to seek further information about the study. Once recruited they will provide informed consent and undergo baseline testing. They will then be randomised to perform upper or lower body exercise first and the other intervention will follow a week later. Therefore it is not necessary or possible to blind the participants to their randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Repeated measures ANOVAs will be performed using IBM Statistical Package for Social Sciences (SPSS, version 20) to assess an effect of exercise type (within subjects: baseline, post lower-body exercise, post upper-body exercise) and group (between subjects: OA, old healthy, young healthy) at the level of P equals 0.05. For pressure pain threshold data the ANOVA models also will include the location of these measures as an additional within subjects factor, either for all 8 sites or for the mean of the 4 lower limb or 4 upper limb measures. T-tests willl be used to assess group differences at baseline (unpaired) as well as within-participant differences between baseline and post-exercise (paired). The number of subjects was calculated via a power analysis based on previous results of post exercise pressure pain thresholds in young healthy populations. As we anticipated a greater variance in older and osteoarthitic populations we were conservative and an n greater than 13 was needed to reach statistical significance with 80% power. As there are 3 groups we anticipated 15 for each group amounting to 45.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2011
Actual
8/09/2011
Date of last participant enrolment
Anticipated
30/11/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 7526 0
2052 - Unsw Sydney
Recruitment postcode(s) [2] 7527 0
2088 - Mosman
Recruitment postcode(s) [3] 7528 0
2093 - Manly Vale

Funding & Sponsors
Funding source category [1] 288199 0
Self funded/Unfunded
Name [1] 288199 0
None
Country [1] 288199 0
Australia
Primary sponsor type
Individual
Name
Benjamin Barry
Address
Exercise Physiology, School of Medical Sciences, Faculty of Medicine. University of New South Wales, Sydney 2052, NSW
Country
Australia
Secondary sponsor category [1] 286925 0
Individual
Name [1] 286925 0
Nicholas Burrows
Address [1] 286925 0
Exercise Physiology, School of Medical Sciences, Faculty of Medicine. University of New South Wales, Sydney 2052, NSW
Country [1] 286925 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290110 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 290110 0
Ethics committee country [1] 290110 0
Australia
Date submitted for ethics approval [1] 290110 0
Approval date [1] 290110 0
17/08/2011
Ethics approval number [1] 290110 0
11277

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

Contacts
Principal investigator
Name 44030 0
Mr Nicholas Burrows
Address 44030 0
Exercise Physiology, School of Medical Sciences, Faculty of Medicine. University of New South Wales, Sydney 2052, NSW
Country 44030 0
Australia
Phone 44030 0
61425322515
Fax 44030 0
Email 44030 0
[email protected]
Contact person for public queries
Name 44031 0
Benjamin Barry
Address 44031 0
Exercise Physiology, School of Medical Sciences, Faculty of Medicine. University of New South Wales, Sydney 2052, NSW
Country 44031 0
Australia
Phone 44031 0
+612 9385 8709
Fax 44031 0
Email 44031 0
[email protected]
Contact person for scientific queries
Name 44032 0
Benjamin Barry
Address 44032 0
Exercise Physiology, School of Medical Sciences, Faculty of Medicine. University of New South Wales, Sydney 2052, NSW
Country 44032 0
Australia
Phone 44032 0
+612 9385 8709
Fax 44032 0
Email 44032 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
No additional documents have been identified.