Knee OsteoarthritisPhase 2/3NCT01099371
Resistance Training in Knee Osteoarthritis
A Phase 2/3 study testing exercise in people with Knee Osteoarthritis, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether: 1. Progressive resistance training improves pain and disability 2. Progressive Resistance training improves muscular strength, ability to walk and quality of life Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2009to Feb 2011
- Phase
- Phase 2/3
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman
- Age between 40-70 years old
- Pain between 3 and 8 on a 10-point numeric pain scale
- Radiographically confirmed knee OA
Who cannot join
- Inflammatory diseases or any comorbidity that prohibit exercises, regular physical activity
- Trip plans for the next 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Progressive Resistance Training in Women With Knee Osteoarthritis
The purpose of this study is to determine whether:
- Progressive resistance training improves pain and disability
- Progressive Resistance training improves muscular strength, ability to walk and quality of life
Read the detailed description
Patients in experimental group participated in a 12-week progressive resistance training using a repetition maximum (RM) exercise in which patients performed 1RM with the maximum bearable weight. Once the 1RM was determined, training was divided into the following regimen: 2 series of 8 repetitions, the first with 50% and the second with 70% of 1RM.
The exercises were knee extension and flexion and hip abduction and adduction, all performed in machines. The 1RM load was reevaluated every 2 weeks.
The control group remained on a three-month waiting list for physiotherapy. Patients were assessed for pain, function, quality of life, muscle strength and six-minute walk test.
- Conditions
- Knee Osteoarthritis
- Being tested
- exercise
- Keywords
- Knee, Osteoarthritis, Exercise
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
progressive resistance training
| Study group | Role | What they receive |
|---|---|---|
| exercise | Experimental | Not described Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessed on a 10-point numeric pain scale
Scale: visual analog scale
Measured: week 0
Secondary outcomes (3)
Disability assessed on WOMAC
Western Ontario McMaster University Osteoarthritis Index Rheumatology An arthritic pain scoring system ranging from 0-no pain/disability to 100-most severe pain/disability
WOMAC-pain, WOMAC-function and WOMAC-stifness
Measured: week 6
Quality of life assessed on the SF-36
Questionnaire Short-form-36
Measured: week 6
Six-minute walk test
To assess distance walked in 6 minutes
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2010 (estimated)
- Study startFeb 2009
- Primary completionFeb 2009 (estimated)
- Study completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Jamil Natour, PhD, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099371
- Sponsor's protocol ID
- FDAAAA
- Status last verified
- Jan 2009
- First submitted
- 1 Apr 2010
- Last updated
- 7 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressive Resistance Training in Women With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01099371
- Acronym / sponsor ID
- FDAAAA
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee, Osteoarthritis, Exercise
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Feb 2009
- Primary completion
- Feb 2009 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 7 Apr 2010 (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.
The purpose of this study is to determine whether:
- Progressive resistance training improves pain and disability
- Progressive Resistance training improves muscular strength, ability to walk and quality of life
Detailed description
Patients in experimental group participated in a 12-week progressive resistance training using a repetition maximum (RM) exercise in which patients performed 1RM with the maximum bearable weight. Once the 1RM was determined, training was divided into the following regimen: 2 series of 8 repetitions, the first with 50% and the second with 70% of 1RM.
The exercises were knee extension and flexion and hip abduction and adduction, all performed in machines. The 1RM load was reevaluated every 2 weeks.
The control group remained on a three-month waiting list for physiotherapy. Patients were assessed for pain, function, quality of life, muscle strength and six-minute walk test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exercise | Experimental | Other: exercise |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Woman
- Age between 40-70 years old
- Pain between 3 and 8 on a 10-point numeric pain scale
- Radiographically confirmed knee OA
Key exclusion criteria (2 listed)
- Inflammatory diseases or any comorbidity that prohibit exercises, regular physical activity
- Trip plans for the next 12 months
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 |
|---|---|---|
| exerciseprogressive resistance training | Other | exercise |
Primary outcome
Pain assessed on a 10-point numeric pain scale
Time frame: week 0
Scale: visual analog scale
3 secondary outcomes
Disability assessed on WOMAC
Time frame: week 6
Quality of life assessed on the SF-36
Time frame: week 6
Six-minute walk test
Time frame: week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2010.
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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.
Jamil Natour, PhD study chair
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing exercise in people with Knee Osteoarthritis, run by Federal University of São Paulo at 1 site in Brazil.
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 4 inclusion and 2 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 7 May 2010. 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 Brazil. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Pain assessed on a 10-point numeric pain scale (time frame: week 0). 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 7 May 2010.