Resistive Exercise for Arthritic Cartilage Health (REACH) - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

April 24, 2007

Last Updated Date

April 24, 2007

Start Date ^†

April 2005

Current Primary Outcome Measures ^†

Articular cartilage morphology following 6 months high intensity progressive resistance training

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current 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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

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

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

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Osteoarthritis

Intervention ^†

Behavioral: Progressive resistance training

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Completion Date

July 2009

Primary Completion Date

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

Gender

Female

Ages

40 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Australia

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00465660

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

University of Sydney

Collaborators ^††

Investigators ^†

Principal Investigator:

Benedicte Vanwanseele, PhD

University of Sydney

Information Provided By

University of Sydney

Verification Date

December 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.