Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of Aquatic Physical Therapy for Knee Osteoarthritis Patients (RCT-OA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02247882
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : May 25, 2017
Sponsor:
Collaborators:
Ministry of Health, Brazil
Fundação Araucária
Information provided by (Responsible Party):
Jefferson Rosa Cardoso, Universidade Estadual de Londrina

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Other: Patient Education Other: Aquatic Physical Therapy Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Health Education Compared to Aquatic Physical Therapy for Patients With Knee Osteoarthritis: a Randomized Clinical Trial
Actual Study Start Date : February 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patient Education
Health Education.
Other: Patient Education

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.

Other Name: Health Education

Active Comparator: Aquatic Physical Therapy
Protocol of aquatic physical therapy exercises.
Other: Aquatic Physical Therapy
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).
Other Name: Aquatic Exercise




Primary Outcome Measures :
  1. Pain [ Time Frame: up to 3 months ]
    Evaluation of pain - EVA


Secondary Outcome Measures :
  1. Function [ Time Frame: 2 and 3 months ]
    Physical Function - WOMAC Index

  2. Balance [ Time Frame: 2 and 3 months ]
    ABC Scale and postural balance

  3. Quality Of Live [ Time Frame: 2 and 3 months ]
    SF-36 Questionaire

  4. kinetic [ Time Frame: 2 and 3 months ]
    Ground Reaction Forces and postural balance



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247882


Locations
Layout table for location information
Brazil
Aquatic Physical Therapy Center "Paulo A. Seibert"
Londrina, Pr, Brazil, 86038440
Sponsors and Collaborators
Universidade Estadual de Londrina
Ministry of Health, Brazil
Fundação Araucária
Investigators
Layout table for investigator information
Principal Investigator: Ligia M Facci, PT, PhD Adjunct Professor

Publications:
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.
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.
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.

Layout table for additonal information
Responsible Party: Jefferson Rosa Cardoso, Ligia Maria Facci, Universidade Estadual de Londrina
ClinicalTrials.gov Identifier: NCT02247882     History of Changes
Other Study ID Numbers: RCTOA14
1406 ( Registry Identifier: Ligia Facci )
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jefferson Rosa Cardoso, Universidade Estadual de Londrina:
Osteoarthritis
Patient Education
Aquatic Exercise
kinetic
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases