Hydrotherapy Intervention in Elderly With Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Hydrotherapy intervention
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, hydrotherapy
Eligibility Criteria
Inclusion Criteria:
- confirmed clinical diagnosis of knee osteoarthritis
Exclusion Criteria:
- total knee arthroplasty
- inability to co-operate or follow instructions.
- a major neurological disorder
Sites / Locations
- Faculty of health Sciences. University of Granada
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hydrotherapy intervention
Control group
Arm Description
30 people will be recruited in order to the inclusion criteria for the study and they will receive an hydrotherapy intervention.
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.
Outcomes
Primary Outcome Measures
Changes in pain pressure threshold
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
Changes in lower extremity strength
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.
Dual task
Dual task is going to be measured using the Timed Up & Go. It assesses basic mobility skill as well as strength, balance, and agility.
Functional ability
Functional ability was assessed by the Western Ontario and McMaster Universities Osteoarthritis Index. Higher scores on the this questionnaire represent greater limitations in function.
Changes in balance
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
Full Information
NCT ID
NCT02048956
First Posted
January 27, 2014
Last Updated
November 1, 2016
Sponsor
Universidad de Granada
1. Study Identification
Unique Protocol Identification Number
NCT02048956
Brief Title
Hydrotherapy Intervention in Elderly With Knee Osteoarthritis
Official Title
8-weeks Hydrotherapy Intervention in Patients With Knee Osteoarthritis.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis, hydrotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydrotherapy intervention
Arm Type
Experimental
Arm Description
30 people will be recruited in order to the inclusion criteria for the study and they will receive an hydrotherapy intervention.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Hydrotherapy intervention
Other Intervention Name(s)
Exercise program, Swimming pool training
Intervention Description
Participants randomized to the exercise programme received a training in a swimming pool focused on dance therapy.
Intervention Type
Other
Intervention Name(s)
Control group
Other Intervention Name(s)
Standard hydrotherapy intervention
Intervention Description
Standard exercises of hydrotherapy
Primary Outcome Measure Information:
Title
Changes in pain pressure threshold
Description
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.
Time Frame
baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Changes in lower extremity strength
Description
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.
Time Frame
baseline, 8 weeks
Title
Dual task
Description
Dual task is going to be measured using the Timed Up & Go. It assesses basic mobility skill as well as strength, balance, and agility.
Time Frame
baseline, 8 weeks
Title
Functional ability
Description
Functional ability was assessed by the Western Ontario and McMaster Universities Osteoarthritis Index. Higher scores on the this questionnaire represent greater limitations in function.
Time Frame
baseline, 8 weeks
Title
Changes in balance
Description
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
Time Frame
baseline, 8 weeks
Other Pre-specified Outcome Measures:
Title
Quality of sleep
Description
Quality of sleep was assessed by Pittsburgh Sleep Quality Index, a self-reported questionnaire.
Time Frame
baseline, 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
confirmed clinical diagnosis of knee osteoarthritis
Exclusion Criteria:
total knee arthroplasty
inability to co-operate or follow instructions.
a major neurological disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Carmen Valenza, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of health Sciences. University of Granada
City
Granada
ZIP/Postal Code
18071
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Hydrotherapy Intervention in Elderly With Knee Osteoarthritis
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