Effects of Therapeutic Exercises in Elderly Women With Knee Osteoarthritis (TherExercOA)
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Therapeutic exercise and Pompage
Educational lectures
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Therapeutic exercises, Pain, Muscle strength, Postural balance
Eligibility Criteria
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Therapeutic exercise and Pompage
Control
Arm Description
strengthening exercises, balance training and knee's pompage
Educational lectures.
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02560831
First Posted
September 22, 2015
Last Updated
September 24, 2015
Sponsor
Universidade Federal de Pernambuco
1. Study Identification
Unique Protocol Identification Number
NCT02560831
Brief Title
Effects of Therapeutic Exercises in Elderly Women With Knee Osteoarthritis
Acronym
TherExercOA
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, Therapeutic exercises, Pain, Muscle strength, Postural balance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic exercise and Pompage
Arm Type
Experimental
Arm Description
strengthening exercises, balance training and knee's pompage
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Educational lectures.
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic exercise and Pompage
Intervention Description
Strengthening exercises for flexors and knee extensors, balance training, knee's pompage twice per week for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Educational lectures
Intervention Description
Educational lectures in four meetings for 12 weeks (Control Group)
Primary Outcome Measure Information:
Title
The concentric muscular peak torque of the knee extensors
Description
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).
Time Frame
3 months
Title
Postural stability
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Level of knee's pain
Description
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.
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
12. IPD Sharing Statement
Learn more about this trial
Effects of Therapeutic Exercises in Elderly Women With Knee Osteoarthritis
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