Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00465660




Registration number
NCT00465660
Ethics application status
Date submitted
24/04/2007
Date registered
25/04/2007
Date last updated
25/04/2007

Titles & IDs
Public title
Resistive Exercise for Arthritic Cartilage Health (REACH)
Scientific title
The Effect of 6 Month High Intensity Progressive Resistance Training on Knee Articular Cartilage Morphology in Female Osteoarthritic Patients
Secondary ID [1] 0 0
ACTRN012605000116628
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Progressive resistance training

Behaviour: Progressive resistance training
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Articular cartilage morphology following 6 months high intensity progressive resistance training
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Muscle and fat cross-sectional area (CSA) (pre and post)
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Muscle strength, power, endurance, and contraction velocity (pre, 3 months, & post)
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Medications (pre, 3 months, & post)
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Body composition (pre, 3 months, & post)
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Balance; Physical function (pre, 3 months, & post)
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Questionnaires (pre, 3 months, & post):
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Habitual exercise (PASE)
Timepoint [7] 0 0
Secondary outcome [8] 0 0
WOMAC index (pain, stiffness and functional ability)
Timepoint [8] 0 0
Secondary outcome [9] 0 0
Depressive symptoms (Depression Scale)
Timepoint [9] 0 0
Secondary outcome [10] 0 0
Quality of life (SF36)
Timepoint [10] 0 0
Secondary outcome [11] 0 0
Confidence performing physical activity (Ewart)
Timepoint [11] 0 0
Secondary outcome [12] 0 0
Demographics
Timepoint [12] 0 0

Eligibility
Key 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
Minimum age
40 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2140 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00465660
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Benedicte Vanwanseele, PhD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00465660