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Resistive Exercise for Arthritic Cartilage Health (REACH)

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ClinicalTrials.gov Identifier: NCT00465660
Recruitment Status : Unknown
Verified December 2006 by University of Sydney.
Recruitment status was:  Active, not recruiting
First Posted : April 25, 2007
Last Update Posted : April 25, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:

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

Condition or disease Intervention/treatment Phase
Osteoarthritis Behavioral: Progressive resistance training Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: The Effect of 6 Month High Intensity Progressive Resistance Training on Knee Articular Cartilage Morphology in Female Osteoarthritic Patients
Study Start Date : April 2005
Estimated Study Completion Date : July 2009

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Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Articular cartilage morphology following 6 months high intensity progressive resistance training

Secondary Outcome Measures :
  1. Muscle and fat cross-sectional area (CSA) (pre and post)
  2. Muscle strength, power, endurance, and contraction velocity (pre, 3 months, & post)
  3. Medications (pre, 3 months, & post)
  4. Body composition (pre, 3 months, & post)
  5. Balance; Physical function (pre, 3 months, & post)
  6. Questionnaires (pre, 3 months, & post):
  7. Habitual exercise (PASE)
  8. WOMAC index (pain, stiffness and functional ability)
  9. Depressive symptoms (Depression Scale)
  10. Quality of life (SF36)
  11. Confidence performing physical activity (Ewart)
  12. Demographics

Eligibility Criteria

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465660


Locations
Australia, New South Wales
University of Sydney
Sydney, New South Wales, Australia, 2140
Sponsors and Collaborators
University of Sydney
Investigators
Principal Investigator: Benedicte Vanwanseele, PhD University of Sydney
More Information

ClinicalTrials.gov Identifier: NCT00465660     History of Changes
Other Study ID Numbers: ACTRN012605000116628
First Posted: April 25, 2007    Key Record Dates
Last Update Posted: April 25, 2007
Last Verified: December 2006

Keywords provided by University of Sydney:
Osteoarthritis
Cartilage
Exercise
Progressive Resistance Training

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases