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Resistive Exercise for Arthritic Cartilage Health (REACH)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by University of Sydney.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Sydney
ClinicalTrials.gov Identifier:
NCT00465660
First received: April 24, 2007
Last updated: NA
Last verified: December 2006
History: No changes posted
  Purpose

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 Intervention Phase
Osteoarthritis
 Behavioral: Progressive resistance training
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: The Effect of 6 Month High Intensity Progressive Resistance Training on Knee Articular Cartilage Morphology in Female Osteoarthritic Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sydney:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 60
Study Start Date: April 2005
Estimated Study Completion Date: July 2009
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00465660     History of Changes
Other Study ID Numbers: ACTRN012605000116628
Study First Received: April 24, 2007
Last Updated: April 24, 2007
Health Authority: Australia: Human Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 22, 2013