Effects of Therapeutic Exercises in Elderly Women With Knee Osteoarthritis
TherExercOA
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
1 other identifier
interventional
22
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 22, 2015
CompletedFirst Posted
Study publicly available on registry
September 25, 2015
CompletedSeptember 25, 2015
September 1, 2015
9 months
September 22, 2015
September 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
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.
3 months
Secondary Outcomes (1)
Level of knee's pain
3 months
Study Arms (2)
Therapeutic exercise and Pompage
EXPERIMENTALstrengthening exercises, balance training and knee's pompage
Control
ACTIVE COMPARATOREducational lectures.
Interventions
Strengthening exercises for flexors and knee extensors, balance training, knee's pompage twice per week for 12 weeks.
Educational lectures in four meetings for 12 weeks (Control Group)
Eligibility Criteria
You may qualify if:
- Female
- Aged between 60 and 80 years
- Diagnosed with knee's osteoarthritis according to clinical and radiographic criteria of the American College of Rheumatology.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Profa. Dra.
Study Record Dates
First Submitted
September 22, 2015
First Posted
September 25, 2015
Study Start
March 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2014
Last Updated
September 25, 2015
Record last verified: 2015-09