Evaluation of the Effectiveness of Self Management Program on Changes in Physical Activity Level of Knee Osteoarthritis Patients in Spa Therapy
GEET One
2 other identifiers
interventional
172
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Jul 2015
Typical duration for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 5, 2015
CompletedFirst Posted
Study publicly available on registry
November 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2017
CompletedNovember 24, 2017
November 1, 2017
1.5 years
November 5, 2015
November 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Level of physical activity at 3 month, with score on IPAQ Short form
at 3 months
Secondary Outcomes (5)
Self efficacy at 3 months with score on ASES
at 3 months
Functional status at 3 months with score on WOMAC
at 3 months
Fears and beliefs at 3 months with score on KOFBeQ
at 3 months
Pain at 3 months with score on EVA
at 3 months
Sarcopenia at 18 days
at 18 days
Study Arms (2)
Intervention group
EXPERIMENTALNo 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)
control group
OTHERNo 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)
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Clermont-Ferrandlead
- Clermont Communautécollaborator
- Innovathermcollaborator
Study Sites (1)
CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France
Related Publications (1)
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.
PMID: 30326906DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2015
First Posted
November 6, 2015
Study Start
July 1, 2015
Primary Completion
January 15, 2017
Study Completion
January 15, 2017
Last Updated
November 24, 2017
Record last verified: 2017-11