Knee OsteoarthritisPhase 1NCT02295605
Comparison Between Land-based and Water-based Exercises for Knee Osteoarthritis: Randomized Controlled Trial
A Phase 1 study testing water-based exercises and land-based exercises in people with Knee Osteoarthritis, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Forty six patients with knee osteoarthritis will be randomly allocated into two groups: water-based exercises and land-based exercises. Both of them will receive a strengthening exercise protocol for lower limb muscles. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- water-based exercises and land-based exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2014to Nov 2015
- Phase
- Phase 1
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate knee osteoarthritis (grade 2 or 3 using the Kellgren-Lawrence radiograph classification), diagnosed based on clinical and radiological criteria of the American College of Rheumatology
- No other lower limb and spine musculoskeletal disorders
- Independent gait
- Body mass index below 32
- Minimum of 4 points in the pain numeric rating scale during climb and descend stairs activities
Who cannot join
- Cognitive or psychological disorders
- Neurological disorders
- History of post-traumatic knee osteoarthritis
- Knee pain at least 12 months
- Prior surgery of the lower limbs or spine
- Fibromyalgia
Show all 9Show fewer
- Rheumatoid arthritis
- Cardiovascular disease
- Participating in exercise programs and received treatment for the knee at least 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between a Land-based and Water-based Muscles Strengthening Program on Patients With Knee Osteoarthritis Randomized Controlled Trial
Forty six patients with knee osteoarthritis will be randomly allocated into two groups: water-based exercises and land-based exercises. Both of them will receive a strengthening exercise protocol for lower limb muscles. A blind investigator will assess the patients before and immediately after, 3 months and 6 months following the interventions. The main outcomes will be pain, function and strength.
Read the detailed description
Forty six patients with knee osteoarthritis will be randomly allocated into two groups: water-based exercises and land-based exercises. Both of them will receive a strengthening exercise protocol for lower limb muscles. A blind investigator will assess the patients before and immediately after, 3 months and 6 months following the interventions. The main outcomes will be pain, function, physical performance and strength.
- Conditions
- Knee Osteoarthritis
- Being tested
- water-based exercises, land-based exercises
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water-based exercisesOther
water-based exercise strengthening protocol for lower limb muscles
land-based exercisesOther
land-based exercise strengthening protocol for lower limb muscles
| Study group | Role | What they receive |
|---|---|---|
| Land-based exercises | Experimental | Land-based muscle strengthening exercises protocol Receives: Other: land-based exercises |
| Water-based exercises | Experimental | Water-based muscle strengthening exercises protocol Receives: Other: water-based exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function
Pain and Function scores on the Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC questionnaire)
Measured: 8 weeks
Secondary outcomes (4)
Physical Performance
Physical Performance scores on the Timed Up and GO test (TUG)
Measured: 8 weeks
Strength muscle
Strength muscle scores measured by heldheld dynamometer
Measured: 8 weeks
Lower Limbs Function
Function Scores on the Lower Extremity Functional Scale (LEFS)
Measured: 8 weeks
Pain
Pain Scores on the Numeric Pain Rating Scale
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2015
- Study completionNov 2015
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Serra Bley, University of Nove de Julho
- Investigators
- José Geraldo S Morelli, PhD student, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295605
- Sponsor's protocol ID
- University of Nove de Julho
- Status last verified
- Jul 2016
- First submitted
- 8 Nov 2014
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between a Land-based and Water-based Muscles Strengthening Program on Patients With Knee Osteoarthritis Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02295605
- Acronym / sponsor ID
- University of Nove de Julho
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 20 Nov 2014 (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.
Forty six patients with knee osteoarthritis will be randomly allocated into two groups: water-based exercises and land-based exercises. Both of them will receive a strengthening exercise protocol for lower limb muscles. A blind investigator will assess the patients before and immediately after, 3 months and 6 months following the interventions. The main outcomes will be pain, function and strength.
Detailed description
Forty six patients with knee osteoarthritis will be randomly allocated into two groups: water-based exercises and land-based exercises. Both of them will receive a strengthening exercise protocol for lower limb muscles. A blind investigator will assess the patients before and immediately after, 3 months and 6 months following the interventions. The main outcomes will be pain, function, physical performance and strength.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Land-based exercises | Experimental | Other: land-based exercisesLand-based muscle strengthening exercises protocol |
| Water-based exercises | Experimental | Other: water-based exercisesWater-based muscle strengthening exercises protocol |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Moderate knee osteoarthritis (grade 2 or 3 using the Kellgren-Lawrence radiograph classification), diagnosed based on clinical and radiological criteria of the American College of Rheumatology
- No other lower limb and spine musculoskeletal disorders
- Independent gait
- Body mass index below 32
- Minimum of 4 points in the pain numeric rating scale during climb and descend stairs activities
Key exclusion criteria (9 listed)
- Cognitive or psychological disorders
- Neurological disorders
- History of post-traumatic knee osteoarthritis
- Knee pain at least 12 months
- Prior surgery of the lower limbs or spine
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 |
|---|---|---|
| water-based exerciseswater-based exercise strengthening protocol for lower limb muscles | Other | Water-based exercises |
| land-based exercisesland-based exercise strengthening protocol for lower limb muscles | Other | Land-based exercises |
Primary outcome
Function
Time frame: 8 weeks
Pain and Function scores on the Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC questionnaire)
4 secondary outcomes
Physical Performance
Time frame: 8 weeks
Strength muscle
Time frame: 8 weeks
Lower Limbs Function
Time frame: 8 weeks
Pain
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2016.
- Individual participant dataSharing planned: Undecided
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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.
José Geraldo S Morelli, PhD student principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing water-based exercises and land-based exercises in people with Knee Osteoarthritis, run by University of Nove de Julho 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 2 Aug 2016. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Function (time frame: 8 weeks). 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 2 Aug 2016.