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

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ClinicalTrials.gov Identifier: NCT02598804
Recruitment Status : Completed
First Posted : November 6, 2015
Last Update Posted : November 24, 2017
Sponsor:
Collaborators:
Clermont Communauté
Innovatherm
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief 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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Physical Activity Education Self-management Exercise Other: 5 educational workshop Other: written information booklet Not Applicable

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  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of the Effectiveness of Self Management Program on Changes in Physical Activity Level of Knee Osteoarthritis Patients in Spa Therapy
Actual Study Start Date : July 2015
Actual Primary Completion Date : January 15, 2017
Actual Study Completion Date : January 15, 2017

Resource links provided by the National Library of Medicine


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
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



Primary Outcome Measures :
  1. Level of physical activity at 3 month, with score on IPAQ Short form [ Time Frame: at 3 months ]

Secondary Outcome Measures :
  1. Self efficacy at 3 months with score on ASES [ Time Frame: at 3 months ]
  2. Functional status at 3 months with score on WOMAC [ Time Frame: at 3 months ]
  3. Fears and beliefs at 3 months with score on KOFBeQ [ Time Frame: at 3 months ]
  4. Pain at 3 months with score on EVA [ Time Frame: at 3 months ]
  5. Sarcopenia at 18 days [ Time Frame: at 18 days ]


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:


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): NCT02598804


Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Clermont Communauté
Innovatherm

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02598804     History of Changes
Other Study ID Numbers: CHU-251
2015-A00831-48 ( Registry Identifier: 2015-A00831-48 )
First Posted: November 6, 2015    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

Keywords provided by University Hospital, Clermont-Ferrand:
Physical activity level
Knee osteoarthritis
Randomized controlled trials
Alternate month design study
Self-management
Self-care
Education and exercise in knee osteoarthritis
Education
Non pharmacological treatment

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases