- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02560831
Effects of Therapeutic Exercises in Elderly Women With Knee Osteoarthritis (TherExercOA)
September 24, 2015 updated by: Marcia Alessandra Carneiro Pedrosa de Castro, Universidade Federal de Pernambuco
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female
- Aged between 60 and 80 years
- Diagnosed with knee's osteoarthritis according to clinical and radiographic criteria of the American College of Rheumatology.
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Therapeutic exercise and Pompage
strengthening exercises, balance training and knee's pompage
|
Strengthening exercises for flexors and knee extensors, balance training, knee's pompage twice per week for 12 weeks.
|
Active Comparator: Control
Educational lectures.
|
Educational lectures in four meetings for 12 weeks (Control Group)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
3 months
|
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.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of knee's pain
Time Frame: 3 months
|
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.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
September 22, 2015
First Submitted That Met QC Criteria
September 24, 2015
First Posted (Estimate)
September 25, 2015
Study Record Updates
Last Update Posted (Estimate)
September 25, 2015
Last Update Submitted That Met QC Criteria
September 24, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE 02993812.3.0000.5208
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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