- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02901964
Effect of Strengthening the Hip Abductor in Patients With Knee Osteoarthritis: Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Ceará
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Fortaleza, Ceará, Brazil, 60430-160
- Federal University Of Ceara
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group Hip Abductor Exercise
12 treatments sessions at 6 weeks: Heating, lower limb stretching, tibiofemoral and patellofemoral mobilization, strengthening the quadriceps, hamstrings, triceps sural and hip abductors.
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12 treatments sessions at 6 weeks: Heating, lower limb stretching, tibiofemoral and patellofemoral mobilization, strengthening the quadriceps, hamstrings, triceps sural and hip abductors.
|
ACTIVE_COMPARATOR: Group Hip Aductor Exercise
12 treatments sessions at 6 weeks: Heating, lower limb stretching, tibiofemoral and patellofemoral mobilization, strengthening the quadriceps, hamstrings, triceps sural and hip aductors.
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12 treatments sessions at 6 weeks: Heating, lower limb stretching, tibiofemoral and patellofemoral mobilization, strengthening the quadriceps, hamstrings, triceps sural and hip aductors.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Pain Scale
Time Frame: Six weeks
|
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.
|
Six weeks
|
Pain and Function subscale - Knee Injury and Osteoarthritis Outcome Score
Time Frame: Six weeks
|
Pain and Function subscale - KOOS was assessed, where 0 corresponded to no pain and normal function and 100 corresponded to worst pain and function.
|
Six weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Others subscales - Knee Injury and Osteoarthritis Outcome Score
Time Frame: Six weeks
|
Six weeks
|
30 s Chair Stand Test
Time Frame: Six weeks
|
Six weeks
|
Timed Up & Go Test
Time Frame: Six weeks
|
Six weeks
|
Global Perceived Effect Scale
Time Frame: Six weeks
|
Six weeks
|
Numeric Pain Scale
Time Frame: Six months
|
Six months
|
Knee Injury and Osteoarthritis Outcome Score
Time Frame: Six months
|
Six months
|
Global Perceived Effect Scale
Time Frame: Six months
|
Six months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gabriel Peixoto Leão Almeida, PhD student, Federal University of Ceará (UFC), Brazil.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Doutorado
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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