NCT02977325

Brief Summary

Questionnaires are often irreplaceable tools of collection of information in research and in the clinical practice. Coupled with other measures, they can be simple complementary tools, but questionnaires are sometimes the only way to collect data, such as self-service efficacy. The objective of this study is a validation of the French translation of the ASES. To guarantee the comparability between the original version and the translated version, the translation of a questionnaire supposes two essential stages: a literal translation and an adaptation to the cultural context, to the habits of life and to the idioms of the target population. This new version will afterward be validated with patient's troop.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
Last Updated

December 5, 2016

Status Verified

December 1, 2016

Enrollment Period

1.1 years

First QC Date

November 28, 2016

Last Update Submit

December 2, 2016

Conditions

Keywords

Physical activity levelPersonal efficacyKnee osteoarthritisSelf-managementSelf-careEducation and exercise in knee osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • personal efficacy by means of the French questionnaire ASES "Arthritis Self-Efficacy Scale"

    at 3 months

  • personal efficacy by means of the French questionnaire ASES "Arthritis Self-Efficacy Scale"

    at 3 months +15 days

Study Arms (2)

Physical activity

One group participated in therapeutic programs centered on the physical activity

Other: water cure

water cure exclusively

This group followed exclusively the water cure

Other: water cure

Interventions

Physical activitywater cure exclusively

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with knee osteoarthritis

You may qualify if:

  • Both sexes, 50-75 years old Knee osteoarthritis Patients affiliated to a social security scheme Patients realizing a Spa Therapy Acceptance to participate in the study

You may not qualify if:

  • \< 50-year-old patients or \> 75 years Inflammatory, tumoral, traumatic or infectious rheumatism Cardiac decompensation Disorders of the concentration or the compression of the written or oral French language.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Osteoarthritis, KneeMotor Activity

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • Emmanuel COUDEYRE

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2016

First Posted

November 30, 2016

Study Start

July 1, 2015

Primary Completion

August 1, 2016

Study Completion

November 1, 2016

Last Updated

December 5, 2016

Record last verified: 2016-12

Locations