NCT02901964

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

September 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

November 2, 2018

Status Verified

October 1, 2018

Enrollment Period

1.7 years

First QC Date

September 5, 2016

Last Update Submit

October 31, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (7)

  • Others subscales - Knee Injury and Osteoarthritis Outcome Score

    Six weeks

  • 30 s Chair Stand Test

    Six weeks

  • Timed Up & Go Test

    Six weeks

  • Global Perceived Effect Scale

    Six weeks

  • Numeric Pain Scale

    Six months

  • +2 more secondary outcomes

Study Arms (2)

Group Hip Abductor Exercise

EXPERIMENTAL

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

Other: Hip Abductor Exercise

Group Hip Aductor Exercise

ACTIVE COMPARATOR

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

Other: Hip Aductor Exercise

Interventions

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

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 aductors.

Group Hip Aductor Exercise

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Ceara

Fortaleza, Ceará, 60430-160, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Gabriel Peixoto Leão Almeida, PhD student

    Federal University of Ceará (UFC), Brazil.

    PRINCIPAL INVESTIGATOR

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
Professor

Study Record Dates

First Submitted

September 5, 2016

First Posted

September 15, 2016

Study Start

September 1, 2016

Primary Completion

May 1, 2018

Study Completion

November 1, 2018

Last Updated

November 2, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

IPD will not be shared.

Locations