- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00465660
Resistive Exercise for Arthritic Cartilage Health (REACH)
The Effect of 6 Month High Intensity Progressive Resistance Training on Knee Articular Cartilage Morphology in Female Osteoarthritic Patients
Female subjects over the age of 40 will be recruited and 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.
It is hypothesised that high intensity PRT will decelerate the tibial and femoral cartilage degeneration in the knee affected most by OA.
Primary Outcome:
Articular cartilage morphology following 6 months high intensity progressive resistance training
Secondary Outcomes:
Muscle and fat cross-sectional area (CSA) (pre and post) Muscle strength, power, endurance, and contraction velocity (pre, 3 months, & post) Medications (pre, 3 months, & post) Body composition (pre, 3 months, & post) Balance; Physical function (pre, 3 months, & post) Questionnaires (pre, 3 months, & post)
- Habitual exercise (PASE) -WOMAC index (pain, stiffness and functional ability)
- Depressive symptoms (Depression Scale) -Quality of life (SF36)
- Confidence performing physical activity (Ewart) -Demographics
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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New South Wales
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Sydney, New South Wales, Australia, 2140
- University of Sydney
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Articular cartilage morphology following 6 months high intensity progressive resistance training
|
Secondary Outcome Measures
Outcome Measure |
---|
Muscle and fat cross-sectional area (CSA) (pre and post)
|
Muscle strength, power, endurance, and contraction velocity (pre, 3 months, & post)
|
Medications (pre, 3 months, & post)
|
Body composition (pre, 3 months, & post)
|
Balance; Physical function (pre, 3 months, & post)
|
Questionnaires (pre, 3 months, & post):
|
Habitual exercise (PASE)
|
WOMAC index (pain, stiffness and functional ability)
|
Depressive symptoms (Depression Scale)
|
Quality of life (SF36)
|
Confidence performing physical activity (Ewart)
|
Demographics
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Benedicte Vanwanseele, PhD, University of Sydney
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACTRN012605000116628
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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