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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02694796
Other study ID # C2015/02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date December 20, 2017

Study information

Verified date June 2018
Source Association Francaise pour la Recherche Thermale
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the impact of an intervention combining a workshop during a balneotherapy and the use after the end of the balneotherapy of a web and smartphone-based physical activity program using connected devices, on physical activity level among patients 12 months after they participated in a balneotherapy in thermal care center.

A multi center randomized controlled trial is setting to evaluate the impact of the intervention on physical activity recommendations achievement of the patients.

Investigators hypothesize that an intervention including a workshop during a balneotherapy and an automated physical activity program using web, mobile phone and connected devices will help patients to be engaged in more physical activities and to reach physical activity recommendations.


Description:

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Study Design


Intervention

Behavioral:
Physical activity program after a balneotherapy
workshop during the balneotherapy associated to an automated program of physical activity after the end of the balneotherapy available during 12 months

Locations

Country Name City State
France Thermes CHEVALLEY Aix-les-Bains
France Centre thermal d'Amélie-les-Bains Amélie-les-Bains
France Thermes de Bourbon-Lancy Bourbon Lancy
France Thermes de Brides-les-Bains Brides-les-Bains
France Caleden Complexe Thermal Chaudes-Aigues
France Centre thermal d'Eugénie-les-Bains Eugénie-les-Bains
France Thermes du Boulou Le Boulou
France Thermes de Vals-les-Bains Vals-les-Bains
France Thermes CALLOU Vichy

Sponsors (1)

Lead Sponsor Collaborator
Association Francaise pour la Recherche Thermale

Country where clinical trial is conducted

France, 

References & Publications (6)

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Outcome

Type Measure Description Time frame Safety issue
Primary Achievement of Physical activity recommendations Proportion of patients in each arm of the study (intervention and control) who achieve physical activity recommendations.
Physical activity will be measured by IPAQ questionnaire (International Physical Activity Questionnaire). Achievement of physical activity recommendations corresponds to 150 minutes of moderate physical activity per week.
To compare physical activity at 12 months, a constrained Longitudinal Data Analysis will be used involving the repeated measure of physical activity at inclusion and every 2 months until the end of the 12 months of follow-up.
at 12 months of follow-up
Secondary Physical activity IPAQ questionnaire to evaluate in each arm of the study physical activity (like physical activity level, sedentary time, the proportion of patients reporting an increase of at least 20 minutes of moderate physical activity per week) at inclusion, 6 and 12 months of follow-up
Secondary Weight at inclusion, 6 and 12 months of follow-up
Secondary Waist circumference at inclusion, 6 and 12 months of follow-up
Secondary Quality of life The quality of life will be measured thanks to the SF-12 questionnaire (Short Form Health Survey) at inclusion, 6 and 12 months of follow-up
Secondary Captured physical activity Physical activity will be measured thanks to accelerometers integrated into smartphones at return home after the end of the balneotherapy, at 6 months and at 12 months of follow-up
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