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OsteoarthritisRCT-OANCT02247882

Effectiveness of Aquatic Physical Therapy for Knee Osteoarthritis Patients

A study testing Patient Education and Aquatic Physical Therapy in people with Osteoarthritis, run by Universidade Estadual de Londrina at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 85 years
Conditions the study is for
Osteoarthritis
What is being tested?
Patient Education and Aquatic Physical Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBrazil
Study dates
Feb 2015to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Aquatic Physical Therapy Center "Paulo A. Seibert"

    Londrina, Paraná, 86038440

Other trials in Brazil

About this study

Official title: Effectiveness of Health Education Compared to Aquatic Physical Therapy for Patients With Knee Osteoarthritis: a Randomized Clinical Trial

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.

Read the detailed description

Sixty patients will be recruited from clinics and through printed newspaper. Physicians who routinely evaluate patients with this diagnosis will be informed of the study, and the same will be announced by television call.

After passing a medical examination confirming the clinical diagnosis of knee osteoarthritis by American College of Rheumatology and other criteria, the elect will be informed of the objectives of the study and invited to participate.

After evaluation of the records of referrals of knee OA, patients receive phone calls, will be informed of the research objectives, questioned regarding the inclusion and exclusion criteria of the study and invited to participate in the study.

Upon study entry, personal information (name, age, gender, address and telephone) will be confirmed by a secretary, who will give the registration number of the patient. Personal information, as well as their radiographs, will be kept in personal form, with number of study enrollment.

Before and after implementation of treatment protocols, as well as after three months, all patients will be assessed by an independent examiner, ie, that have no knowledge about the intervention with respect to different variables. The independent examiner will have been previously trained for this role to become fit to do so.

Individuals will be assessed using the rubric for the outcomes of pain intensity using a Visual Analogue Scale (VAS); functional capacity of the Western Ontario and McMaster Universities Index (WOMAC); balance the Activities-specific Balance Confidence (ABC) and by static posturography and reaction forces to the ground by static force platform. Body weight will be checked by portable scale; height, and waist circumference with tape measure to calculate BMI.

After evaluation, patients will be divided by the numbers generated by the computer through the site (www.random.org) in both treatment groups with 30 patients. After the generation of numbers, they will be transformed into a card with the assigned treatment (1- Patient Education; 2 Aquatic Physiotherapy) and then placed in sealed, opaque, sequentially numbered envelopes. Thus, it prevented the evaluator and the therapist choose the group to which the patient is assigned. Procedures for randomization and allocation, as well as assessments and interventions will be blinded.

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, lasting two hours, to be held in the Parlor of Our Lady of Grace Church, belonging to the scope of the Health Unit Vila Brazil.

The program will include education, following the suggestions of Coleman et al. 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. Following, practical activities on the themes will be addressed.

To enhance the information at the end, patients will receive printed material with the guidelines given by the professional. Still, the first and last day of the education program, patients will respond a questionnaire addressing their knowledge about the disease developed by the researchers.

Supervised aquatic exercise will run individually, twice a week, lasting 60 minutes, for eight weeks, totaling 16 sessions at the Center for Aquatic Physical Therapy Professor Paulo Armindo Seibert, Universidade Estadual de Londrina. The water temperature will be maintained at approximately 32 degrees, with a depth of 1.20m. 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 water running); 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).

Both groups will receive guidance home exercises two to three times a week, and reinforced by familiar previously illustrated booklets, which include the same goals of aquatic exercises: heating, self stretching of the lower limb muscles, isometric and dynamic exercises of the lower limbs , proprioceptive and functional exercises, aerobic exercises is relaxation.

Three months after the end of intervention protocols, ie, at the end of follow-up, patients in the group Education will be invited to perform aquatic therapy and patients in group aquatic therapy will receive the manual of educational guidelines.

Conditions
Osteoarthritis
Being tested
Patient Education, Aquatic Physical Therapy
Keywords
Osteoarthritis, Patient Education, Aquatic Exercise, kinetic
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient EducationOther

    Also called Health 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.

  • Aquatic Physical TherapyOther

    Also called Aquatic Exercise

    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).

Study groups in NCT02247882
Study groupRoleWhat they receive
Patient EducationExperimentalHealth Education.
Receives: Other: Patient Education
Aquatic Physical TherapyActive comparatorProtocol of aquatic physical therapy exercises.
Receives: Other: Aquatic Physical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain

    Evaluation of pain - EVA

    Measured: up to 3 months

Secondary outcomes (4)
  1. Function

    Physical Function - WOMAC Index

    Measured: 2 and 3 months

  2. Balance

    ABC Scale and postural balance

    Measured: 2 and 3 months

  3. Quality Of Live

    SF-36 Questionaire

    Measured: 2 and 3 months

  4. kinetic

    Ground Reaction Forces and postural balance

    Measured: 2 and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2014 (estimated)
  2. Study startFeb 2015
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02247882
Sponsor's protocol ID
RCTOA14
Other IDs
1406
Acronym
RCT-OA
Status last verified
May 2017
First submitted
21 Sep 2014
Last updated
25 May 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 20541439
  • 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.

    PubMed 6226917
  • 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.

  • 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.

    PubMed 23778771
  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Patient Education and Aquatic Physical Therapy in people with Osteoarthritis, run by Universidade Estadual de Londrina at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain (time frame: up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02247882, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2017.

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