Resistive Exercise for Arthritic Cartilage Health (REACH)

Sponsor

University of Sydney (Other)

Overall Status

Unknown status

CT.gov ID

NCT00465660

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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

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 :

Apr 1, 2005

Study Completion Date :

Jul 1, 2009

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Sydney	Sydney	New South Wales	Australia	2140

Sponsors and Collaborators

University of Sydney

Investigators

Principal Investigator: Benedicte Vanwanseele, PhD, University of Sydney

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00465660

Other Study ID Numbers:

ACTRN012605000116628

First Posted:

Apr 25, 2007

Last Update Posted:

Apr 25, 2007

Last Verified:

Dec 1, 2006

Keywords provided by , ,

Osteoarthritis

Cartilage

Exercise

Progressive Resistance Training

Additional relevant MeSH terms:

Osteoarthritis

Study Results

No Results Posted as of Apr 25, 2007