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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02901964
Other study ID # Doutorado
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date November 2018

Study information

Verified date October 2018
Source Universidade Federal do Ceara
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date November 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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.
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.

Locations

Country Name City State
Brazil Federal University of Ceara Fortaleza Ceará

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal do Ceara

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Six weeks
Primary 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. Six weeks
Secondary Others subscales - Knee Injury and Osteoarthritis Outcome Score Six weeks
Secondary 30 s Chair Stand Test Six weeks
Secondary Timed Up & Go Test Six weeks
Secondary Global Perceived Effect Scale Six weeks
Secondary Numeric Pain Scale Six months
Secondary Knee Injury and Osteoarthritis Outcome Score Six months
Secondary Global Perceived Effect Scale Six months
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