search
Back to results

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

Primary Purpose

Knee Osteoarthritis, Physical Activity, Education

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
5 educational workshop
written information booklet
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Knee Osteoarthritis focused on measuring 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

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention group

control group

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Level of physical activity at 3 month, with score on IPAQ Short form

Secondary Outcome Measures

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

Full Information

First Posted
November 5, 2015
Last Updated
November 22, 2017
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Clermont Communauté, Innovatherm
search

1. Study Identification

Unique Protocol Identification Number
NCT02598804
Brief Title
Evaluation of the Effectiveness of Self Management Program on Changes in Physical Activity Level of Knee Osteoarthritis Patients in Spa Therapy
Acronym
GEET One
Official Title
Evaluation of the Effectiveness of Self Management Program on Changes in Physical Activity Level of Knee Osteoarthritis Patients in Spa Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
January 15, 2017 (Actual)
Study Completion Date
January 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Clermont Communauté, Innovatherm

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Physical Activity, Education, Self-management, Exercise
Keywords
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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)
Arm Title
control group
Arm Type
Other
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
5 educational workshop
Intervention Type
Other
Intervention Name(s)
written information booklet
Primary Outcome Measure Information:
Title
Level of physical activity at 3 month, with score on IPAQ Short form
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
Self efficacy at 3 months with score on ASES
Time Frame
at 3 months
Title
Functional status at 3 months with score on WOMAC
Time Frame
at 3 months
Title
Fears and beliefs at 3 months with score on KOFBeQ
Time Frame
at 3 months
Title
Pain at 3 months with score on EVA
Time Frame
at 3 months
Title
Sarcopenia at 18 days
Time Frame
at 18 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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: -
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
30326906
Citation
Gay C, Guiguet-Auclair C, Pereira B, Goldstein A, Bareyre L, Coste N, Coudeyre E. Efficacy of self-management exercise program with spa therapy for behavioral management of knee osteoarthritis: research protocol for a quasi-randomized controlled trial (GEET one). BMC Complement Altern Med. 2018 Oct 16;18(1):279. doi: 10.1186/s12906-018-2339-x.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs