Evaluation of the Effectiveness of Self Management Program on Changes in Physical Activity Level of Knee Osteoarthritis Patients in Spa Therapy (GEET One)

November 22, 2017 updated by: University Hospital, Clermont-Ferrand
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

172

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

  • France
      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand

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

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group

No single group but 2 groups :

  • Intervention group (5 educational workshop in addition to spa therapy)
  • Control group (Written information booklet in addition to spa therapy)
Other: 5 educational workshop
Other: control group

No single group but 2 groups :

  • Intervention group (5 educational workshop in addition to spa therapy)
  • Control group (Written information booklet in addition to spa therapy)
Other: written information booklet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of physical activity at 3 month, with score on IPAQ Short form
Time Frame: at 3 months
at 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Self efficacy at 3 months with score on ASES
Time Frame: at 3 months
at 3 months
Functional status at 3 months with score on WOMAC
Time Frame: at 3 months
at 3 months
Fears and beliefs at 3 months with score on KOFBeQ
Time Frame: at 3 months
at 3 months
Pain at 3 months with score on EVA
Time Frame: at 3 months
at 3 months
Sarcopenia at 18 days
Time Frame: at 18 days
at 18 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Innovatherm
Clermont Communauté

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

July 1, 2015

Primary Completion (Actual)

January 15, 2017

Study Completion (Actual)

January 15, 2017

Study Registration Dates

First Submitted

November 5, 2015

First Submitted That Met QC Criteria

November 5, 2015

First Posted (Estimate)

November 6, 2015

Study Record Updates

Last Update Posted (Actual)

November 24, 2017

Last Update Submitted That Met QC Criteria

November 22, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-251
  • 2015-A00831-48 (Registry Identifier: 2015-A00831-48)

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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