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Trial registered on ANZCTR


Trial ID
ACTRN12605000116628
Ethics application status
Approved
Date submitted
5/08/2005
Date registered
9/08/2005
Date last updated
20/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of progressive resistance training on knee articular cartilage morphology in osteoarthritic patients
Scientific title
The effect of 6 month high intensity progressive resistance training on knee articular cartilage morphology in female osteoarthritic patients
Universal Trial Number (UTN)
Trial acronym
REACH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 204 0
Condition category
Condition code
Musculoskeletal 228 228 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be randomised into a progressive resistance training (PRT) or sham-exercise group. The PRT group will train at 80% of their peak strength, using Keiser pneumatic resistance machines, and progress approximately 3% per session. Strength will be re-assessed fortnightly. Exercises will target muscles around the hip and knee. The sham-exercise group will train on the same equipment as the PRT group except hip adduction, but without added resistance or progression. Both groups will train 3 days per week for roughly 45 minutes for 6 months.
Intervention code [1] 132 0
Treatment: Other
Comparator / control treatment
Sham-exercise group.
Control group
Placebo

Outcomes
Primary outcome [1] 275 0
Articular cartilage morphology following 6 months high intensity progressive resistance training.
Timepoint [1] 275 0
Following 6 months high intensity progressive resistance training.
Secondary outcome [1] 614 0
Muscle and fat cross-sectional area (CSA)
Timepoint [1] 614 0
Pre and post
Secondary outcome [2] 615 0
Muscle strength, power, endurance, and contraction velocity
Timepoint [2] 615 0
Pre, 3 months, & post
Secondary outcome [3] 616 0
Medications
Timepoint [3] 616 0
Pre, 3 months, & post
Secondary outcome [4] 617 0
Body composition
Timepoint [4] 617 0
Pre, 3 months, & post
Secondary outcome [5] 618 0
Balance; Physical function
Timepoint [5] 618 0
Pre, 3 months, & post
Secondary outcome [6] 619 0
Questionnaires
-Habitual exercise (PASE) -WOMAC index (pain, stiffness and functional ability)
-Depressive symptoms (Depression Scale) -Quality of life (SF36)
-Confidence performing physical activity (Ewart) -Demographics
Timepoint [6] 619 0
Pre, 3 months, & post

Eligibility
Key inclusion criteria
Primary Osteoarthritis in at least one knee using standard criteria of the American College of Rheumatology (ACR) criteria for classification of clinical osteoarthritis -Ambulatory without human assistance-Willingness to be randomised to experiential or control group-Ability to attend scheduled exercise and testing sessions
Minimum age
40 Years
Maximum age
Not stated
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Regular exercise of any kind over the past 3 months (>1dpw). -Secondary osteoarthritis (traumatic or post-surgical), rheumatic disease, gouty or septic arthritis, Paget's disease, pseudogout, major congenital abnormalities, hemochromatosis, Wilson's disease and other rare forms of arthritis -Joint injury, injection or surgery within the past 6 months or knee joint replacement.

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)
Randomisation of subjects will be carried out using opaque envelopes with their exercise group assignment inside. The label in the envelope will only state Group A or Group B. Researchers will not disclose to subjects which group is hypothesized to be the preferential group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using randomisation software from www.randomization.com. Subjects will be stratified according to WOMAC scores (cut-off WOMAC difficulty score of 53) and whether or not they are currently taking and/or have taken (last 6 months) either glucosamine or chondroitin at any dosage (yes/no)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not 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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 289 0
University
Name [1] 289 0
Cumberland Grant Category B. University of Sydney
Address [1] 289 0
Faculty of Health Science University of Sydney PO Box 170 Lidcombe NSW 1825
Country [1] 289 0
Australia
Funding source category [2] 2485 0
University
Name [2] 2485 0
University of Sydney R & D Grant (S4201 U3301)
Address [2] 2485 0
Faculty of Health Science University of Sydney PO Box 170 Lidcombe NSW 1825
Country [2] 2485 0
Australia
Primary sponsor type
University
Name
University of Sydney, Faculty of Health Sciences, School of Exercise and Sport Science
Address
Faculty of Health Science University of Sydney PO Box 170 Lidcombe NSW 1825
Country
Australia
Secondary sponsor category [1] 220 0
None
Name [1] 220 0
no
Address [1] 220 0
Country [1] 220 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1142 0
University of Sydney Human Research Ethics Committee.
Ethics committee address [1] 1142 0
Ethics committee country [1] 1142 0
Australia
Date submitted for ethics approval [1] 1142 0
Approval date [1] 1142 0
Ethics approval number [1] 1142 0
Ethics committee name [2] 1143 0
Prince of Wales Medical Research Institute
Ethics committee address [2] 1143 0
Ethics committee country [2] 1143 0
Australia
Date submitted for ethics approval [2] 1143 0
Approval date [2] 1143 0
Ethics approval number [2] 1143 0

Summary
Brief summary
Trial website
http://www2.fhs.usyd.edu.au/ess/vanwanseele/reach.htm
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35541 0
Address 35541 0
Country 35541 0
Phone 35541 0
Fax 35541 0
Email 35541 0
Contact person for public queries
Name 9321 0
Ms. Angela Lange
Address 9321 0
School of Exercise and Sport Science
Faculty of Health Science
University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 9321 0
Australia
Phone 9321 0
+61 2 93519279
Fax 9321 0
+61 2 93519204
Email 9321 0
alan5625@mail.usyd.edu.au
Contact person for scientific queries
Name 249 0
Dr. Benedicte Vanwanseele
Address 249 0
School of Exercise and Sport Science
Faculty of Health Science
University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 249 0
Australia
Phone 249 0
+61 2 93519328
Fax 249 0
+61 2 93519204
Email 249 0
b.vanwanseele@usyd.edu.au