Clinical trial NCT00465660: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Cartilage
Exercise
Progressive Resistance Training
Lead sponsor: University of Sydney
Sponsor class: OTHER
First posted: 2007-04-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Articular cartilage morphology following 6 months high intensity progressive resistance training
Secondary outcomes:
measure: Muscle and fat cross-sectional area (CSA) (pre and post)
measure: Muscle strength, power, endurance, and contraction velocity (pre, 3 months, & post)
measure: Medications (pre, 3 months, & post)
measure: Body composition (pre, 3 months, & post)
measure: Balance; Physical function (pre, 3 months, & post)
measure: Questionnaires (pre, 3 months, & post):
measure: Habitual exercise (PASE)
measure: WOMAC index (pain, stiffness and functional ability)
measure: Depressive symptoms (Depression Scale)
measure: Quality of life (SF36)
measure: Confidence performing physical activity (Ewart)
measure: Demographics
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: University of Sydney
state: New South Wales
Study officials:
affiliation: University of Sydney
name: Benedicte Vanwanseele, PhD
role: PRINCIPAL_INVESTIGATOR
References: