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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00465660




Registration number
NCT00465660
Ethics application status
Date submitted
24/04/2007
Date registered
25/04/2007
Date last updated
25/04/2007

Titles & IDs
Public title
Resistive Exercise for Arthritic Cartilage Health (REACH)
Scientific title
The Effect of 6 Month High Intensity Progressive Resistance Training on Knee Articular Cartilage Morphology in Female Osteoarthritic Patients
Secondary ID [1] 0 0
ACTRN012605000116628
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Articular cartilage morphology following 6 months high intensity progressive resistance training
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Muscle and fat cross-sectional area (CSA) (pre and post)
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Muscle strength, power, endurance, and contraction velocity (pre, 3 months, & post)
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Medications (pre, 3 months, & post)
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Body composition (pre, 3 months, & post)
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Balance; Physical function (pre, 3 months, & post)
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Questionnaires (pre, 3 months, & post):
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Habitual exercise (PASE)
Timepoint [7] 0 0
Secondary outcome [8] 0 0
WOMAC index (pain, stiffness and functional ability)
Timepoint [8] 0 0
Secondary outcome [9] 0 0
Depressive symptoms (Depression Scale)
Timepoint [9] 0 0
Secondary outcome [10] 0 0
Quality of life (SF36)
Timepoint [10] 0 0
Secondary outcome [11] 0 0
Confidence performing physical activity (Ewart)
Timepoint [11] 0 0
Secondary outcome [12] 0 0
Demographics
Timepoint [12] 0 0

Eligibility
Key inclusion criteria
* Female
* Aged over 40 years old
* 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
No limit
Sex
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
* Contraindications to MRI/Exercise

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2005
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)
NSW
Recruitment hospital [1] 0 0
University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2140 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Benedicte Vanwanseele, PhD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00465660