NCT02919020

Brief Summary

To evaluate the effectiveness of the method Proprioceptive Neuromuscular Facilitation (PNF) as physical therapy approach to the reduction of pain and improvement in functional performance and quality of life in women with knee osteoarthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

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

First Submitted

Initial submission to the registry

September 24, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

1.9 years

First QC Date

September 24, 2016

Last Update Submit

July 17, 2021

Conditions

Osteoarthritis Knee

Keywords

Proprioceptive Neuromuscular Facilitation (PNF )resistance exercise

Outcome Measures

Primary Outcomes (6)

  • Change in pain

    "Pain control diary"

    "change from baseline in pain 6th - 12th week"

  • Quality of life

    Western Ontario and McMaster Universities Questionaire

    change from baseline in quality of life 6th-12th week

  • Functional performance

    "30 s -chair stand test"

    Change based on functional performance 6th - 12th week

  • Quality of life

    Medical Outcomes Study 36 - Item Short - Form Health Survey

    Change based on functional performance 6th - 12th week

  • Functional Performance

    "Walk Test of 40 meters at a rapid pace

    Change based on functional performance 6th - 12th week

  • Functional Performance

    "Stair climb test"

    "Walk Test of 40 meters at a rapid pace

Secondary Outcomes (2)

  • pain sensitivity threshold

    change from baseline in pain threshold 6th-12th week pressure

  • Range of motion

    "change from baseline in the range of knee flexion 6th-12th week"

Study Arms (2)

Proprioceptive neuromuscular facilitation (PNF);

EXPERIMENTAL

Proprioceptive neuromuscular facilitation, using the technique of rhythmic initiation and Combination of Isotonic on lower members

Other: Proprioceptive neuromuscular facilitation (PNF)

resistance exercise

EXPERIMENTAL

Resistance exercise to strengthen lower limbs

Other: Resistance exercise

Interventions

Proprioceptive neuromuscular facilitation (PNF)OTHER

Proprioceptive neuromuscular facilitation, using the technique of rhythmic initiation and Combination of Isotonic on lower members

Proprioceptive neuromuscular facilitation (PNF);
Resistance exerciseOTHER

resistance exercise to strengthen lower limbs

resistance exercise

Eligibility Criteria

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

You may qualify if:

  • Women;
  • Age between 50 and 80 years;
  • Clinical diagnosis of Osteoarthritis of knees ;
  • Patients with presence of at least 90 ° range of motion of knee flexion ;
  • Do not practitioners of physical exercise and physical therapy during the period of participation in the survey

You may not qualify if:

  • Diagnosis of other rheumatological and neurological diseases ;
  • orthopedic surgery History in the lower limbs ;
  • Individuals with muscle strength of the lower limbs \<3 ;
  • Cognitive impairment or neurological disease that compromises the understanding and implementation of the Protocol (Mini Mental State Examination \<18 for the illiterate and \<24 for others);
  • Body mass index ≥ 30.0 (obesity , according to the World Health Organization ) .
  • Individuals classified as physical activity level "very active" by the IPAQ (International Physical Activity Questionnaire ) .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitário Drº Washigton Antônio de Barros

Petrolina, Pernambuco, 50710430, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Muscle Stretching ExercisesResistance Training

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPhysical Conditioning, Human

Study Officials

  • Daniella A Oliveira

    Universidade Federal de Pernambuco

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigador Principal

Study Record Dates

First Submitted

September 24, 2016

First Posted

September 29, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2018

Study Completion

February 1, 2019

Last Updated

July 22, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)