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Resistive Exercise for Arthritic Cartilage Health (REACH)

Primary Purpose

Osteoarthritis

Status
Unknown status
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Progressive resistance training
Sponsored by
University of Sydney
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Cartilage, Exercise, Progressive Resistance Training

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Sydney

Outcomes

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

Full Information

First Posted
April 24, 2007
Last Updated
April 24, 2007
Sponsor
University of Sydney
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1. Study Identification

Unique Protocol Identification Number
NCT00465660
Brief Title
Resistive Exercise for Arthritic Cartilage Health (REACH)
Official Title
The Effect of 6 Month High Intensity Progressive Resistance Training on Knee Articular Cartilage Morphology in Female Osteoarthritic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Unknown status
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2009 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sydney

4. Oversight

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, Cartilage, Exercise, Progressive Resistance Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Progressive resistance training
Primary Outcome Measure Information:
Title
Articular cartilage morphology following 6 months high intensity progressive resistance training
Secondary Outcome Measure Information:
Title
Muscle and fat cross-sectional area (CSA) (pre and post)
Title
Muscle strength, power, endurance, and contraction velocity (pre, 3 months, & post)
Title
Medications (pre, 3 months, & post)
Title
Body composition (pre, 3 months, & post)
Title
Balance; Physical function (pre, 3 months, & post)
Title
Questionnaires (pre, 3 months, & post):
Title
Habitual exercise (PASE)
Title
WOMAC index (pain, stiffness and functional ability)
Title
Depressive symptoms (Depression Scale)
Title
Quality of life (SF36)
Title
Confidence performing physical activity (Ewart)
Title
Demographics

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benedicte Vanwanseele, PhD
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sydney
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2140
Country
Australia

12. IPD Sharing Statement

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