OsteoarthritisPhase 2NCT00465660
Resistive Exercise for Arthritic Cartilage Health (REACH)
A Phase 2 study testing Progressive resistance training in people with Osteoarthritis, run by University of Sydney at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Progressive resistance training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2005to Jul 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of 6 Month High Intensity Progressive Resistance Training on Knee Articular Cartilage Morphology in Female Osteoarthritic Patients
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.
Read more
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
- Conditions
- Osteoarthritis
- Being tested
- Progressive resistance training
- Keywords
- Osteoarthritis, Cartilage, Exercise, Progressive Resistance Training
- Medical subject headings
- Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive resistance trainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Articular cartilage morphology following 6 months high intensity progressive resistance training
Secondary outcomes (12)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study startApr 2005
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Investigators
- Benedicte Vanwanseele, PhD, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465660
- Sponsor's protocol ID
- ACTRN012605000116628
- Status last verified
- Dec 2006
- First submitted
- 24 Apr 2007
- Last updated
- 25 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 6 Month High Intensity Progressive Resistance Training on Knee Articular Cartilage Morphology in Female Osteoarthritic Patients
- ClinicalTrials.gov ID
- NCT00465660
- Acronym / sponsor ID
- ACTRN012605000116628
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Cartilage, Exercise, Progressive Resistance Training
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Jul 2009
- First posted
- 25 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive resistance training | Behavioural | – |
Primary outcome
Articular cartilage morphology following 6 months high intensity progressive resistance training
12 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benedicte Vanwanseele, PhD principal investigator
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Progressive resistance training in people with Osteoarthritis, run by University of Sydney at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Articular cartilage morphology following 6 months high intensity progressive resistance training. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2007.