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Resistive Exercise for Arthritic Cartilage Health (REACH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
University of Sydney

Tracking Information
First Submitted Date  ICMJE April 24, 2007
First Posted Date  ICMJE April 25, 2007
Last Update Posted Date April 25, 2007
Study Start Date  ICMJE April 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2007)
Articular cartilage morphology following 6 months high intensity progressive resistance training
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2007)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Resistive Exercise for Arthritic Cartilage Health (REACH)
Official Title  ICMJE The Effect of 6 Month High Intensity Progressive Resistance Training on Knee Articular Cartilage Morphology in Female Osteoarthritic Patients
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE Behavioral: Progressive resistance training
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: April 24, 2007)
60
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE July 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00465660
Other Study ID Numbers  ICMJE ACTRN012605000116628
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Sydney
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Benedicte Vanwanseele, PhD University of Sydney
PRS Account University of Sydney
Verification Date December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP