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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Physical Activity, Chronic Diseases, Obesity, Diabetes, Rheumatic Diseases, Cardiovascular Diseases, Breast Cancer, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Behavioral: Physical activity program after a balneotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The 'Physical activity program after a balneotherapy' intervention involves providing a workshop during a balneotherapy about physical activity and use of automated physical activity program including website, mobile app and connected devices, and after the balneotherapy, the access to the automated program during 12 months. | Behavioral: Physical activity program after a balneotherapy<br>* workshop during the balneotherapy associated to an automated program of physical activity after the end of the balneotherapy available during 12 months<br>|
| No Intervention: Control<br>Patients included in the control arm will receive a booklet including informations about physical activity recommendations and practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Weight |  | at inclusion, 6 and 12 months of follow-up | 
| Waist circumference |  | at inclusion, 6 and 12 months of follow-up | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Connected devices, Web and smartphone-based physical activity program, Balneotherapy