NCT02247882

Brief Summary

The purpose of this study is to determine whether education or aquatic physical therapy are effective in the treatment of osteoarthritis in Knee due to intensity of pain, function capacity, quality of life and kinetic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 25, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

September 21, 2014

Last Update Submit

May 23, 2017

Conditions

Osteoarthritis

Keywords

OsteoarthritisPatient EducationAquatic Exercisekinetic

Outcome Measures

Primary Outcomes (1)

  • Pain

    Evaluation of pain - EVA

    up to 3 months

Secondary Outcomes (4)

  • Function

    2 and 3 months

  • Balance

    2 and 3 months

  • Quality Of Live

    2 and 3 months

  • kinetic

    2 and 3 months

Study Arms (2)

Patient Education

EXPERIMENTAL

Health Education.

Other: Patient Education

Aquatic Physical Therapy

ACTIVE COMPARATOR

Protocol of aquatic physical therapy exercises.

Other: Aquatic Physical Therapy

Interventions

Patient EducationOTHER

The educational program will comprise a multidisciplinary team: doctor, pharmacist, nurse, nutritionist, psychologist, physiotherapist and physical educator. Classes will be weekly in groups for eight weeks, with a duration of two hours. The education program will include the following items: guidelines about the disease and its complications, strategies for pain management (pharmacological and cognitive), physical exercise, nutrition and weight control, medication (type, interactions, current trends, side effects ), balance, proprioception, fall prevention, coping with chronic pain.

Also known as: Health Education
Patient Education
Aquatic Physical TherapyOTHER

The exercise protocol will consist of: five minutes of heating with walking and patellar mobilization; ten minutes stretching the muscles of the lower limbs (quadriceps, gluteus, adductors and abductors of hip sural triceps and hamstrings); ten minutes isometric and dynamic exercises with elastic (quadriceps, gluteus, adductors and abductors of hip sural triceps and hamstrings); twenty minutes away from aerobic exercise (stationary running deep running water); ten minutes in functional training step and proprioceptive exercises; and five minutes of cooling with stretching of muscles of lower limbs (quadriceps, gluteus, adductors and abductors of hip sural triceps and hamstrings).

Also known as: Aquatic Exercise
Aquatic Physical Therapy

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients aged between 60 and 85 years;
  • patients with knee OA by a physician confirmed by the criteria of American College of Rheumatology;
  • patients with clinical and cognitive activities for the realization of the pool conditions, confirmed by the Mini-Exam Mental state.

You may not qualify if:

  • patients undergoing surgical procedures in the last six months;
  • patients with chronic diseases such as coronary, other rheumatic diseases such as rheumatoid arthritis; serious diseases such as cancer; chronic obstructive pulmonary diseases; uncontrolled hypertensive;
  • patients unable to walk without aid equipment;
  • patients who have contraindications to practice exercises;
  • patients who have contraindications for entry into the pool, such as urinary or fecal incontinence and skin problems;
  • patients participating in nutrition programs or physical activity in the last two months (or resisted aerobic activity more than once a week for at least two months);
  • patients with metal implants in the lower limbs;
  • patients with morbid obesity (body mass index (BMI)\> 40 kg / m 2);
  • Patients unable to continue the study by programmed change of address or hospitalization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aquatic Physical Therapy Center "Paulo A. Seibert"

Londrina, Paraná, 86038440, Brazil

Location

Related Publications (6)

  • Lyytinen T, Liikavainio T, Bragge T, Hakkarainen M, Karjalainen PA, Arokoski JP. Postural control and thigh muscle activity in men with knee osteoarthritis. J Electromyogr Kinesiol. 2010 Dec;20(6):1066-74. doi: 10.1016/j.jelekin.2010.05.005. Epub 2010 Jun 11.

    PMID: 20541439BACKGROUND

  • Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.

    PMID: 6226917BACKGROUND

  • Fernandes MI. Tradução e validação do questionário de qualidade de vida específico para osteoartrose WOMAC (Western Ontario McMasterUniversities) para a língua portuguesa. São Paulo, 2002. 103p. Tese de Mestrado - Universidade Federal de São Paulo - Escola Paulista de Medicina - Reumatologia.

    BACKGROUND

  • Marques AP, Mendes YC, Taddei U, Pereira CA, Assumpcao A. Brazilian-Portuguese translation and cross cultural adaptation of the activities-specific balance confidence (ABC) scale. Braz J Phys Ther. 2013 Mar-Apr;17(2):170-8. doi: 10.1590/S1413-35552012005000072.

    PMID: 23778771BACKGROUND

  • Duarte M, Freitas SMSF. Revisão sobre posturografia baseada em plataforma de força para avaliação do equilíbrio. Rev Bras Fisioter, São Carlos, v. 14, n. 3, p. 183-92, maio/jun. 2010.

    BACKGROUND

  • CICONELLI RM, FERRAZ MB, SANTOS W, MEINÃO I, QUARESMA MR. Tradução para a língua portuguesa e validação do questionário genérico de avaliação da qualidade de vida SF-36 (Brasil SF-36).RevBrasreumatol 1999; 39(3): 143-150.

    BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Patient Education as TopicAquatic Therapy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Ligia M Facci, PT, PhD

    Adjunct Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ligia Maria Facci

Study Record Dates

First Submitted

September 21, 2014

First Posted

September 25, 2014

Study Start

February 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 25, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will share

Locations

BR(1)