- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02048956
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
Intervention / Treatment
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
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Granada, Spain, 18071
- Faculty of Health Sciences. University of Granada
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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.
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Participants randomized to the exercise programme received a training in a swimming pool focused on dance therapy.
Other Names:
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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.
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Standard exercises of hydrotherapy
Other Names:
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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.
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baseline, 8 weeks
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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.
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baseline, 8 weeks
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Dual task
Time Frame: baseline, 8 weeks
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Dual task is going to be measured using the Timed Up & Go.
It assesses basic mobility skill as well as strength, balance, and agility.
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baseline, 8 weeks
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Functional ability
Time Frame: baseline, 8 weeks
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Functional ability was assessed by the Western Ontario and McMaster Universities Osteoarthritis Index.
Higher scores on the this questionnaire represent greater limitations in function.
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baseline, 8 weeks
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Changes in balance
Time Frame: baseline, 8 weeks
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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
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baseline, 8 weeks
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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.
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baseline, 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DF0049UG
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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