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Effect of Strengthening the Hip Abductor in Patients With Knee Osteoarthritis: Randomized Controlled Trial

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Hip Abductor Exercise
Hip Aductor Exercise
Sponsored by
Universidade Federal do Ceara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • OA knee radiograph grades 2 - 4 according to the Kellgren-Lawrence scale;
  • Reporting knee pain with minimum intensity of 3 on Numerical Pain Scale;
  • Complaints of pain and functional reduction in the last three months;
  • Meet at least one of the American College of Rheumatology classification criteria;
  • Deambulation independent;
  • Absence of prostheses or orthoses
  • Predominant pain in the medial aspect of the knee.

Exclusion Criteria:

  • Contraindications for physical exercises evaluated by the Physical Activity Readiness Questionnaire (PAR-Q);
  • Diabetes type I or decompensated;
  • Hypertension decompensated;
  • Cardiac pacemaker;
  • Cancer History
  • Neurological deficits (sensory or motor)
  • Body mass index above 40 kg / m2
  • Hip symptomatic osteoarthriti
  • Orthopedic surgery of the lower limbs
  • Systemic inflammatory disease
  • Can not walk.

Sites / Locations

  • Federal University of Ceara

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group Hip Abductor Exercise

Group Hip Aductor Exercise

Arm Description

12 treatments sessions at 6 weeks: Heating, lower limb stretching, tibiofemoral and patellofemoral mobilization, strengthening the quadriceps, hamstrings, triceps sural and hip abductors.

12 treatments sessions at 6 weeks: Heating, lower limb stretching, tibiofemoral and patellofemoral mobilization, strengthening the quadriceps, hamstrings, triceps sural and hip aductors.

Outcomes

Primary Outcome Measures

Numeric Pain Scale
Pain was assessed by use of an 11-point Numeric Pain Scale, where 0 corresponded to no pain and 10 corresponded to worst imaginable pain.
Pain and Function subscale - Knee Injury and Osteoarthritis Outcome Score
Pain and Function subscale - KOOS was assessed, where 0 corresponded to no pain and normal function and 100 corresponded to worst pain and function.

Secondary Outcome Measures

Others subscales - Knee Injury and Osteoarthritis Outcome Score
30 s Chair Stand Test
Timed Up & Go Test
Global Perceived Effect Scale
Numeric Pain Scale
Knee Injury and Osteoarthritis Outcome Score
Global Perceived Effect Scale

Full Information

First Posted
September 5, 2016
Last Updated
October 31, 2018
Sponsor
Universidade Federal do Ceara
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1. Study Identification

Unique Protocol Identification Number
NCT02901964
Brief Title
Effect of Strengthening the Hip Abductor in Patients With Knee Osteoarthritis: Randomized Controlled Trial
Official Title
Effect of Strengthening the Hip Abductor in Patients With Knee Osteoarthritis: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Ceara

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Osteoarthritis (OA) is a prevalent disease associated with significant morbidity and is one of the most common causes of joint pain. Characterized by their chronicity, slow and progressive evolution. The overall prevalence of symptomatic knee osteoarthritis is estimated at 3.8%, with peak prevalence in the population with an average age of 50 years. The main objectives of interventions in patients with knee OA are reduced pain and improved functional capacity and exercises are widely recommended. The literature shows a lack of clinical trials verifying the effect of strengthening the hip muscles in patients with knee osteoarthritis. Thus, the aim of this study is to assess the effect of strengthening the hip abductor muscles versus hip adductor muscles in patients with symptomatic OA of the knee.
Detailed Description
The physical therapy sessions will average duration of one hour, often twice a week for six weeks. The exercise intensity will be monitored by the physiotherapist as determined by the participant's ability to complete 10 repetitions for a particular exercise and its difficulty of execution perceived by the modified Borg scale (CR-10). The exercises are performed with load between 60-80% of their capacity, the load will be increased from 2 to 10% when the patient can perform 14 full repetitions in the last series (76). It will be set to 30 seconds of rest between reps and 2 minutes between sets of exercise. Both groups will perform prior heating exercises exercise bike for 10 minutes with moderate intensity with the Borg scale. Then there will be two stretches repetitions held for 30 seconds of muscle groups: hamstrings, quadriceps, abductors, adductors and gastrocnemius. Manual therapy for patellofemoral and tibiofemoral joint will be held after the completion of stretching. Recent clinical guidelines on knee OA strongly recommend the use of strengthening exercises of the lower limbs, both in closed kinetic chain and open. Thus, they will be performed strengthening exercises in extension and knee flexion in open kinetic chain, squat up and down a step and exercises to sural triceps. For symptom control during exercise in CKC will be used the numeric scale of pain before and after its execution. The GABQ add the hip abduction exercises in lateral decubitus, exercise "Clam" and pelvic elevation. Studies prior point out that these exercises are among those with higher electromyographic activity of the gluteus medius muscle. The GADQ add the adduction exercises hip in lateral recumbency, bilateral adduction with a ball between the legs and functional diagonal leg. The exercises will be carried out to load 60-80% of 1 repetition maximum 8-12 reps, 1-3 sets and 2-3 times a week. All exercises are performed without worsening pain and intensity of exercise will be controlled according to the perceived exertion scale of Borg.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Hip Abductor Exercise
Arm Type
Experimental
Arm Description
12 treatments sessions at 6 weeks: Heating, lower limb stretching, tibiofemoral and patellofemoral mobilization, strengthening the quadriceps, hamstrings, triceps sural and hip abductors.
Arm Title
Group Hip Aductor Exercise
Arm Type
Active Comparator
Arm Description
12 treatments sessions at 6 weeks: Heating, lower limb stretching, tibiofemoral and patellofemoral mobilization, strengthening the quadriceps, hamstrings, triceps sural and hip aductors.
Intervention Type
Other
Intervention Name(s)
Hip Abductor Exercise
Intervention Description
12 treatments sessions at 6 weeks: Heating, lower limb stretching, tibiofemoral and patellofemoral mobilization, strengthening the quadriceps, hamstrings, triceps sural and hip abductors.
Intervention Type
Other
Intervention Name(s)
Hip Aductor Exercise
Intervention Description
12 treatments sessions at 6 weeks: Heating, lower limb stretching, tibiofemoral and patellofemoral mobilization, strengthening the quadriceps, hamstrings, triceps sural and hip aductors.
Primary Outcome Measure Information:
Title
Numeric Pain Scale
Description
Pain was assessed by use of an 11-point Numeric Pain Scale, where 0 corresponded to no pain and 10 corresponded to worst imaginable pain.
Time Frame
Six weeks
Title
Pain and Function subscale - Knee Injury and Osteoarthritis Outcome Score
Description
Pain and Function subscale - KOOS was assessed, where 0 corresponded to no pain and normal function and 100 corresponded to worst pain and function.
Time Frame
Six weeks
Secondary Outcome Measure Information:
Title
Others subscales - Knee Injury and Osteoarthritis Outcome Score
Time Frame
Six weeks
Title
30 s Chair Stand Test
Time Frame
Six weeks
Title
Timed Up & Go Test
Time Frame
Six weeks
Title
Global Perceived Effect Scale
Time Frame
Six weeks
Title
Numeric Pain Scale
Time Frame
Six months
Title
Knee Injury and Osteoarthritis Outcome Score
Time Frame
Six months
Title
Global Perceived Effect Scale
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: OA knee radiograph grades 2 - 4 according to the Kellgren-Lawrence scale; Reporting knee pain with minimum intensity of 3 on Numerical Pain Scale; Complaints of pain and functional reduction in the last three months; Meet at least one of the American College of Rheumatology classification criteria; Deambulation independent; Absence of prostheses or orthoses Predominant pain in the medial aspect of the knee. Exclusion Criteria: Contraindications for physical exercises evaluated by the Physical Activity Readiness Questionnaire (PAR-Q); Diabetes type I or decompensated; Hypertension decompensated; Cardiac pacemaker; Cancer History Neurological deficits (sensory or motor) Body mass index above 40 kg / m2 Hip symptomatic osteoarthriti Orthopedic surgery of the lower limbs Systemic inflammatory disease Can not walk.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Peixoto Leão Almeida, PhD student
Organizational Affiliation
Federal University of Ceará (UFC), Brazil.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Ceara
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60430-160
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared.

Learn more about this trial

Effect of Strengthening the Hip Abductor in Patients With Knee Osteoarthritis: Randomized Controlled Trial

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