Overview

This trial is active, not recruiting.

Condition osteoarthritis
Treatment progressive resistance training
Phase phase 2
Sponsor University of Sydney
Start date April 2005
End date July 2009
Trial size 60 participants
Trial identifier NCT00465660, ACTRN012605000116628

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind
Primary purpose treatment

Primary Outcomes

Measure
Articular cartilage morphology following 6 months high intensity progressive resistance training
time frame:

Secondary Outcomes

Measure
Muscle and fat cross-sectional area (CSA) (pre and post)
time frame:
Muscle strength, power, endurance, and contraction velocity (pre, 3 months, & post)
time frame:
Medications (pre, 3 months, & post)
time frame:
Body composition (pre, 3 months, & post)
time frame:
Balance; Physical function (pre, 3 months, & post)
time frame:
Questionnaires (pre, 3 months, & post):
time frame:
Habitual exercise (PASE)
time frame:
WOMAC index (pain, stiffness and functional ability)
time frame:
Depressive symptoms (Depression Scale)
time frame:
Quality of life (SF36)
time frame:
Confidence performing physical activity (Ewart)
time frame:
Demographics
time frame:

Eligibility Criteria

Female participants at least 40 years old.

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

Additional Information

Official title The Effect of 6 Month High Intensity Progressive Resistance Training on Knee Articular Cartilage Morphology in Female Osteoarthritic Patients
Principal investigator Benedicte Vanwanseele, PhD
Trial information was received from ClinicalTrials.gov and was last updated in April 2007.
Information provided to ClinicalTrials.gov by University of Sydney.