Impact of Web and Smartphone-based Physical Activity Program on Physical Activity Level 12 Months After a Balneotherapy

Breast Cancer Clinical Trial

— THERMACTIVE  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02694796
• Other study ID #: C2015/02
• Status: Completed
• Phase: N/A
• 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
• 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:

New technologies such as mobile phone and connected devices have been recognized as useful tools to assist chronic patients in their disease's management. they are also considering as promising tools to help patients to change their lifestyle behavior.

Balneotherapy is a very special moment to initiate changes and to raise awareness about healthier behavior in terms of food and physical activity.

The objective of the intervention is to help patients with chronic diseases, taking part in a balneotherapy, to increase or maintain their physical activity level in the long term to reach the national recommendations of 150 minutes of moderate physical activity per week.

Patients will be randomized either in the intervention group or in the control group.

The intervention group will participate in a workshop during the balneotherapy providing them informations about physical activity and also about the way to use the web and smartphone-based physical activity program along with the use of the connected devices (scale and pedometer). After the end of the balneotherapy, the intervention group will have access to the web and smartphone-based physical activity program during 12 months.

The control group will receive a booklet including informations about physical activity practice.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Cardiovascular Diseases
• Chronic Disease
• Chronic Diseases
• Chronic Obstructive Pulmonary Disease
• Collagen Diseases
• Diabetes
• Lung Diseases
• Lung Diseases, Obstructive
• Obesity
• Physical Activity
• Pulmonary Disease, Chronic Obstructive
• Rheumatic Diseases

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)

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

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