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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02048956
Other study ID # DF0049UG
Secondary ID
Status Completed
Phase N/A
First received January 27, 2014
Last updated November 1, 2016
Start date January 2014
Est. completion date August 2016

Study information

Verified date November 2016
Source Universidad de Granada
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date August 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 60 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Hydrotherapy intervention
Participants randomized to the exercise programme received a training in a swimming pool focused on dance therapy.
Control group
Standard exercises of hydrotherapy

Locations

Country Name City State
Spain Faculty of health Sciences. University of Granada Granada

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other Quality of sleep Quality of sleep was assessed by Pittsburgh Sleep Quality Index, a self-reported questionnaire. baseline, 8 weeks Yes
Primary 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. baseline, 8 weeks Yes
Secondary 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. baseline, 8 weeks Yes
Secondary 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. baseline, 8 weeks Yes
Secondary 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. baseline, 8 weeks Yes
Secondary 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 baseline, 8 weeks Yes
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