OsteoarthritisTherExercOANCT02560831
Effects of Therapeutic Exercises in Elderly Women With Knee Osteoarthritis
A study testing Therapeutic exercise and Pompage and Educational lectures in people with Osteoarthritis, run by Universidade Federal de Pernambuco.
Trial summary
Knee Osteoarthritis is a degenerative disease associated with muscle weakness, arthralgia, rigidity and postural instability. Therapeutic exercise can reduce pain and improve muscle strength and postural balance, however benefits from association with pompage is not known. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women only
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Therapeutic exercise and Pompage and Educational lectures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Dec 2014
- Phase
- Interventional
- 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 60 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Aged between 60 and 80 years
- Diagnosed with knee's osteoarthritis according to clinical and radiographic criteria of the American College of Rheumatology.
Who cannot join
- Cardiovascular and/or unstable respiratory diseases
- Knee or hip arthroplasty; in the last 6 months: surgery on lower limbs, intraarticular corticosteroid injection in the knee, physical therapy
- Associated diseases that contribute to the balance disorders (for example ankylosing spondylitis, rheumatoid arthritis, diabetes mellitus, neurological diseases, Parkinson's disease, cerebral palsy and vestibular).
About this study
Official title: Assessment of the Effects of Therapeutic Exercises Associated With Pompage Technique on Pain, Muscle Strength and Postural Balance in Older Women With Knee Osteoarthritis: a Randomized Clinical Trial
Knee Osteoarthritis is a degenerative disease associated with muscle weakness, arthralgia, rigidity and postural instability. Therapeutic exercise can reduce pain and improve muscle strength and postural balance, however benefits from association with pompage is not known. This study aims to evaluate the effects of therapeutic exercise on pain, muscle strength and postural balance in elderly women with knee osteoarthritis. Methodology: Almost randomized controlled trial, in which were included elderly between 60 and 80 years diagnosed with knee osteoarthritis, randomized into two groups with 11 participants each. Intervention group held strengthening exercises for flexors and knee extensors, balance training, and manual knee pompage for 12 weeks. Control Group received educational lectures. Arthralgia was estimated by pain subscale of the questionnaire Western Ontario McMaster Universities Osteoarthritis Index and (WOMAC); muscle strength was assessed by the isokinetic dynamometer HUMAC® NORM Testing \& Rehabilitation System and the postural balance by the Biodex Balance SD postural stability protocol (Biodex Medical Systems, Inc. New York, USA). The Student t test was used for statistical analysis.
- Conditions
- Osteoarthritis
- Being tested
- Therapeutic exercise and Pompage, Educational lectures
- Keywords
- Osteoarthritis, Therapeutic exercises, Pain, Muscle strength, Postural balance
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exercise and PompageBehavioural
Strengthening exercises for flexors and knee extensors, balance training, knee's pompage twice per week for 12 weeks.
Educational lecturesBehavioural
Educational lectures in four meetings for 12 weeks (Control Group)
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic exercise and Pompage | Experimental | strengthening exercises, balance training and knee's pompage Receives: Behavioral: Therapeutic exercise and Pompage |
| Control | Active comparator | Educational lectures. Receives: Behavioral: Educational lectures |
What is being measured
The primary outcome is the main question the study is designed to answer.
The concentric muscular peak torque of the knee extensors
By isokinetic dynamometer HUMAC® NORM Testing \& Rehabilitation System. It was rated the peak concentric muscle torque of knee extensors of both lower limbs at the speed of 120º/s. Patients were instructed to perform the knee extension at maximum amplitude pain-free permitted, then the maximum pain-free range in flexion. Movements of extension and flexion were performed five times for the participants to familiarize themselves with the procedure before the test. Then, five replicates were performed, and the highest amount recorded as peak muscle torque. All data were corrected by gravity. The values recorded in Newton-meters (Nm) were adjusted for body weight (kg) and presented as a percentage. For better analysis of peak concentric muscle torque of the knee extensors, the more symptomatic knee was assessed using the Visual Analogue Scale (VAS).
Measured: 3 months
Postural stability
We used the Postural Stability Protocol, bipedal evaluation, eyes open eight resistance level and three repetitions of 20s with 10s rest. To mark the position of the feet, was adopted as the reference line of the heel and toe of the average tendon. The patient is positioned in front of a monitor containing a target and a cursor and Postural Stability protocol information. The therapist effected verbal command for the patient to keep a point at the center of the target, in which a lowest score (least deviation from the center) was desirable. The hand support or withdrawal of the platform legs was not allowed. Before the test, a simulation of the procedure was performed.
Measured: 3 months
Secondary outcomes (1)
Level of knee's pain
Was estimated by pain subscale of the questionnaire Western Ontario McMaster Universities Osteoarthritis Index and (WOMAC). This questionnaire consists of three domains: pain (5 questions), stiffness (2 questions) and functionality (17 questions), whose questions are answered by the volunteer about their perception in the last 72 hours. Higher scores indicate worse pain frame, rigidity or functionality. In our study, we used the score of the WOMAC pain questionnaire section. The items were evaluated levels: none, low, moderate, severe and very intense. For data analysis, the levels were calculated using a Likert 5-point scale: 0, 25, 50, 75 and 100.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startMar 2013
- Primary completionDec 2013
- Study completionDec 2014
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcia Alessandra Carneiro Pedrosa de Castro, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560831
- Sponsor's protocol ID
- CAAE 02993812.3.0000.5208
- Acronym
- TherExercOA
- Status last verified
- Sep 2015
- First submitted
- 22 Sep 2015
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effects of Therapeutic Exercises Associated With Pompage Technique on Pain, Muscle Strength and Postural Balance in Older Women With Knee Osteoarthritis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02560831
- Acronym / sponsor ID
- TherExercOA / CAAE 02993812.3.0000.5208
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Therapeutic exercises, Pain, Muscle strength, Postural balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Sep 2015 (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.
Knee Osteoarthritis is a degenerative disease associated with muscle weakness, arthralgia, rigidity and postural instability. Therapeutic exercise can reduce pain and improve muscle strength and postural balance, however benefits from association with pompage is not known. This study aims to evaluate the effects of therapeutic exercise on pain, muscle strength and postural balance in elderly women with knee osteoarthritis. Methodology: Almost randomized controlled trial, in which were included elderly between 60 and 80 years diagnosed with knee osteoarthritis, randomized into two groups with 11 participants each. Intervention group held strengthening exercises for flexors and knee extensors, balance training, and manual knee pompage for 12 weeks. Control Group received educational lectures. Arthralgia was estimated by pain subscale of the questionnaire Western Ontario McMaster Universities Osteoarthritis Index and (WOMAC); muscle strength was assessed by the isokinetic dynamometer HUMAC® NORM Testing \& Rehabilitation System and the postural balance by the Biodex Balance SD postural stability protocol (Biodex Medical Systems, Inc. New York, USA). The Student t test was used for statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic exercise and Pompage | Experimental | Behavioral: Therapeutic exercise and Pompagestrengthening exercises, balance training and knee's pompage |
| Control | Active comparator | Behavioral: Educational lecturesEducational lectures. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- Aged between 60 and 80 years
- Diagnosed with knee's osteoarthritis according to clinical and radiographic criteria of the American College of Rheumatology.
Key exclusion criteria (3 listed)
- Cardiovascular and/or unstable respiratory diseases
- Knee or hip arthroplasty; in the last 6 months: surgery on lower limbs, intraarticular corticosteroid injection in the knee, physical therapy
- Associated diseases that contribute to the balance disorders (for example ankylosing spondylitis, rheumatoid arthritis, diabetes mellitus, neurological diseases, Parkinson's disease, cerebral palsy and vestibular).
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 |
|---|---|---|
| Therapeutic exercise and PompageStrengthening exercises for flexors and knee extensors, balance training, knee's pompage twice per week for 12 weeks. | Behavioural | Therapeutic exercise and Pompage |
| Educational lecturesEducational lectures in four meetings for 12 weeks (Control Group) | Behavioural | Control |
Primary outcome
The concentric muscular peak torque of the knee extensors
Time frame: 3 months
By isokinetic dynamometer HUMAC® NORM Testing \& Rehabilitation System. It was rated the peak concentric muscle torque of knee extensors of both lower limbs at the speed of 120º/s. Patients were instructed to perform the knee extension at maximum amplitude pain-free permitted, then the maximum pain-free range in flexion. Movements of extension and flexion were performed five times for the participants to familiarize themselves with the procedure before the test. Then, five replicates were performed, and the highest amount recorded as peak muscle torque. All data were corrected by gravity. The values recorded in Newton-meters (Nm) were adjusted for body weight (kg) and presented as a percentage. For better analysis of peak concentric muscle torque of the knee extensors, the more symptomatic knee was assessed using the Visual Analogue Scale (VAS).
Postural stability
Time frame: 3 months
We used the Postural Stability Protocol, bipedal evaluation, eyes open eight resistance level and three repetitions of 20s with 10s rest. To mark the position of the feet, was adopted as the reference line of the heel and toe of the average tendon. The patient is positioned in front of a monitor containing a target and a cursor and Postural Stability protocol information. The therapist effected verbal command for the patient to keep a point at the center of the target, in which a lowest score (least deviation from the center) was desirable. The hand support or withdrawal of the platform legs was not allowed. Before the test, a simulation of the procedure was performed.
1 secondary outcome
Level of knee's pain
Time frame: 3 months
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 25 Sep 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic exercise and Pompage and Educational lectures in people with Osteoarthritis, run by Universidade Federal de Pernambuco.
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 3 inclusion and 3 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 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The concentric muscular peak torque of the knee extensors (time frame: 3 months). The study lists 2 primary outcomes in all. 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 Sep 2015.