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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02598804
Other study ID # CHU-251
Secondary ID 2015-A00831-48
Status Completed
Phase N/A
First received November 5, 2015
Last updated November 22, 2017
Start date July 2015
Est. completion date January 15, 2017

Study information

Verified date November 2017
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose is to evaluate the benefit of an education action of exercise on the level of physical activity in patients with knee osteoarthritis with the waning of a spa treatment for three weeks, three months after the start of the cure.


Description:

The aim of this study is to prove the effectiveness of an educational intervention in thermal environment on physical activity level with knee osteoarthritis patients.


Recruitment information / eligibility

Status Completed
Enrollment 172
Est. completion date January 15, 2017
Est. primary completion date January 15, 2017
Accepts healthy volunteers No
Gender All
Age group 50 Years to 75 Years
Eligibility Inclusion Criteria:

- Patients, male or female, aged 50 to 75 years.

- Patients with knee osteoarthritis clinical criteria of the American College of Rheumatology (ACR)

- Patient affiliated to a social security scheme (beneficiary entitled)

- Patient registered spa

- Patient has given its consent in writing to

Exclusion Criteria:

Study Design


Intervention

Other:
5 educational workshop

written information booklet


Locations

Country Name City State
France CHU Clermont-Ferrand Clermont-Ferrand

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand Clermont Communauté, Innovatherm

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Level of physical activity at 3 month, with score on IPAQ Short form at 3 months
Secondary Self efficacy at 3 months with score on ASES at 3 months
Secondary Functional status at 3 months with score on WOMAC at 3 months
Secondary Fears and beliefs at 3 months with score on KOFBeQ at 3 months
Secondary Pain at 3 months with score on EVA at 3 months
Secondary Sarcopenia at 18 days at 18 days
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