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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
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Therapeutic exercises, Pain, Muscle strength, Postural balance

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    September 22, 2015
    Last Updated
    September 24, 2015
    Sponsor
    Universidade Federal de Pernambuco
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    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

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    Effects of Therapeutic Exercises in Elderly Women With Knee Osteoarthritis

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