NCT02560831

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Status
completed

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

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
Last Updated

September 25, 2015

Status Verified

September 1, 2015

Enrollment Period

9 months

First QC Date

September 22, 2015

Last Update Submit

September 24, 2015

Conditions

Keywords

OsteoarthritisTherapeutic exercisesPainMuscle strengthPostural balance

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

EXPERIMENTAL

strengthening exercises, balance training and knee's pompage

Behavioral: Therapeutic exercise and Pompage

Control

ACTIVE COMPARATOR

Educational lectures.

Behavioral: Educational lectures

Interventions

Strengthening exercises for flexors and knee extensors, balance training, knee's pompage twice per week for 12 weeks.

Therapeutic exercise and Pompage

Educational lectures in four meetings for 12 weeks (Control Group)

Control

Eligibility Criteria

Age60 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

OsteoarthritisPain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

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