Resistive Exercise for Arthritic Cartilage Health (REACH)

Osteoarthritis Clinical Trial

Official title:

The Effect of 6 Month High Intensity Progressive Resistance Training on Knee Articular Cartilage Morphology in Female Osteoarthritic Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00465660
• Other study ID #: ACTRN012605000116628
• Status: Active, not recruiting
• Phase: Phase 2
• First received: April 24, 2007
• Last updated: April 24, 2007
• Start date: April 2005
• Est. completion date: July 2009

Study information

• Verified date: December 2006
• Source: University of Sydney
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Behavioral:
• Progressive resistance training

Locations

Country	Name	City	State
Australia	University of Sydney	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
University of Sydney

Country where clinical trial is conducted

Australia, 

Outcome

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