Breast Cancer Clinical Trial
— THERMACTIVEOfficial title:
Long Term Impact of a Physical Activity Intervention Combining Workshop During a Balneotherapy and a Web and Smartphone-based Physical Activity Program After Balneotherapy, on Physical Activity Level : a Randomized Control Trial
Verified date | June 2018 |
Source | Association Francaise pour la Recherche Thermale |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 230 |
Est. completion date | December 20, 2017 |
Est. primary completion date | December 20, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 79 Years |
Eligibility |
Inclusion Criteria: - age between 50 and 79 - BMI between 19 and 35 kg.m2 - stabilized chronic disease : cardiovascular disease, obesity, diabetes, chronic obstructive pulmonary disease, rheumatic diseases, breast cancer - practice of moderate physical activity less than 150 minutes per week - practice of sportive activity less than 2h per week - having access to internet - possessing a smartphone connected to internet - good comprehension of french - notice and informed consent signed - no contraindication to practice physical activity - subject to French Social Security Exclusion Criteria: - wearing a cardiac pacemaker - non-stabilized chronic disease - invalidating pathology of locomotor system - metastatic cancers - being in an exclusion period for participating in another study or having received more than 4500€ during the year due to participation in clinical studies - being under supervision - refusing to be register in the French National Volunteers Register |
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 |
Lead Sponsor | Collaborator |
---|---|
Association Francaise pour la Recherche Thermale |
France,
Aalbers T, Baars MA, Rikkert MG. Characteristics of effective Internet-mediated interventions to change lifestyle in people aged 50 and older: a systematic review. Ageing Res Rev. 2011 Sep;10(4):487-97. doi: 10.1016/j.arr.2011.05.001. Epub 2011 May 20. Review. — View Citation
Ammann R, Vandelanotte C, de Vries H, Mummery WK. Can a website-delivered computer-tailored physical activity intervention be acceptable, usable, and effective for older people? Health Educ Behav. 2013 Apr;40(2):160-70. doi: 10.1177/1090198112461791. Epub 2012 Oct 16. — View Citation
Irvine AB, Gelatt VA, Seeley JR, Macfarlane P, Gau JM. Web-based intervention to promote physical activity by sedentary older adults: randomized controlled trial. J Med Internet Res. 2013 Feb 5;15(2):e19. doi: 10.2196/jmir.2158. — View Citation
Krebs P, Prochaska JO, Rossi JS. A meta-analysis of computer-tailored interventions for health behavior change. Prev Med. 2010 Sep-Oct;51(3-4):214-21. doi: 10.1016/j.ypmed.2010.06.004. Epub 2010 Jun 15. — View Citation
Martin SS, Feldman DI, Blumenthal RS, Jones SR, Post WS, McKibben RA, Michos ED, Ndumele CE, Ratchford EV, Coresh J, Blaha MJ. mActive: A Randomized Clinical Trial of an Automated mHealth Intervention for Physical Activity Promotion. J Am Heart Assoc. 2015 Nov 9;4(11). pii: e002239. doi: 10.1161/JAHA.115.002239. — View Citation
van der Weegen S, Verwey R, Spreeuwenberg M, Tange H, van der Weijden T, de Witte L. It's LiFe! Mobile and Web-Based Monitoring and Feedback Tool Embedded in Primary Care Increases Physical Activity: A Cluster Randomized Controlled Trial. J Med Internet Res. 2015 Jul 24;17(7):e184. doi: 10.2196/jmir.4579. — View Citation
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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