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Hydrotherapy Intervention in Elderly With Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02048956
Recruitment Status : Completed
First Posted : January 29, 2014
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: Hydrotherapy intervention Other: Control group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 8-weeks Hydrotherapy Intervention in Patients With Knee Osteoarthritis.
Study Start Date : January 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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.
Other: 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.
Other: Control group
Standard exercises of hydrotherapy
Other Name: Standard hydrotherapy intervention

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

Other Outcome Measures:
  1. 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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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • confirmed clinical diagnosis of knee osteoarthritis

Exclusion Criteria:

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

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): NCT02048956

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Faculty of health Sciences. University of Granada
Granada, Spain, 18071
Sponsors and Collaborators
Universidad de Granada
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Principal Investigator: Marie Carmen Valenza, PhD Universidad de Granada
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Responsible Party: Marie Carmen Valenza, assistant professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT02048956    
Other Study ID Numbers: DF0049UG
First Posted: January 29, 2014    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Marie Carmen Valenza, Universidad de Granada:
knee osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases