Hydrotherapy Intervention in Elderly With Knee Osteoarthritis

November 1, 2016 updated by: Marie Carmen Valenza, Universidad de Granada

8-weeks Hydrotherapy Intervention in Patients With Knee Osteoarthritis.

Knee osteoarthritis is a common condition characterized by pain and functional disability in older people. Prevalence increases with age and is more frequent in older women. The aim of this study was to assess the effects of an 8-weeks hydrotherapy training with elastic bands on pain and functional disability in old people with knee osteoarthritis.

Study Overview

Status

Completed

Conditions

Detailed Description

The main symptoms of knee osteoarthritis are pain and functional disability. These symptoms are caused by a progressive loss and deterioration of articular cartilage with reactive new bone formation at the joint's surface and margins involving articular cartilage, soft tissues and bone damage. Many treatment programs have been developed, including medication with nonsteroidal anti-inflammatory drugs, physical modalities, and therapeutic exercises. It is hypothesized that a hydrotherapy treatment during 8 weeks would benefit patients with knee osteoarthritis.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Granada, Spain, 18071
        • Faculty of Health Sciences. University of Granada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • confirmed clinical diagnosis of knee osteoarthritis

Exclusion Criteria:

  • total knee arthroplasty
  • inability to co-operate or follow instructions.
  • a major neurological disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hydrotherapy intervention
30 people will be recruited in order to the inclusion criteria for the study and they will receive an hydrotherapy intervention.
Participants randomized to the exercise programme received a training in a swimming pool focused on dance therapy.
Other Names:
  • Exercise program
  • Swimming pool training
ACTIVE_COMPARATOR: Control group
30 people will be recruited and included in this control group. The are not going to receive hydrotherapy treatment, only the treatment they receive as usual.
Standard exercises of hydrotherapy
Other Names:
  • Standard hydrotherapy intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in pain pressure threshold
Time Frame: baseline, 8 weeks
The pain pressure threshold is defined as the minimum amount of pressure necessary to induce pain or tenderness . It was measured using a pressure algometer (Somedic AB, Sweden), which is a device with a 1 cm diameter rubber disc at the end on quadriceps muscle.
baseline, 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in lower extremity strength
Time Frame: baseline, 8 weeks
Changes in the strength of lower limbs is going to be assessed using the Stairs Climbing Test. This test assesses the ability to ascend and descend a flight of stairs, as well as lower extremity strength, power, and balance.
baseline, 8 weeks
Dual task
Time Frame: baseline, 8 weeks
Dual task is going to be measured using the Timed Up & Go. It assesses basic mobility skill as well as strength, balance, and agility.
baseline, 8 weeks
Functional ability
Time Frame: baseline, 8 weeks
Functional ability was assessed by the Western Ontario and McMaster Universities Osteoarthritis Index. Higher scores on the this questionnaire represent greater limitations in function.
baseline, 8 weeks
Changes in balance
Time Frame: baseline, 8 weeks
The in balance after the treatment is going to be assessed using the single leg stance. This is a clinical tool that is often used to assess balance and postural steadiness. Subjects are asked to lift one leg off the floor based on their preference and keep the leg raised as long as possible without touching the other leg or the floor
baseline, 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of sleep
Time Frame: baseline, 8 weeks
Quality of sleep was assessed by Pittsburgh Sleep Quality Index, a self-reported questionnaire.
baseline, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

January 27, 2014

First Submitted That Met QC Criteria

January 27, 2014

First Posted (ESTIMATE)

January 29, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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