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NCT Number: NCT02694796

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

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.

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Key information

Conditions

Physical Activity Behavior Body Weight Breast Cancer Breast Diseases Breast Neoplasms Cardiovascular Diseases Chronic Disease Chronic Diseases Chronic Obstructive Pulmonary Disease Connective Tissue Diseases Diabetes Diabetes Mellitus Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Lung Diseases Lung Diseases, Obstructive Metabolic Diseases Motor Activity Musculoskeletal Diseases Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Rheumatic Diseases Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

50 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thermes CHEVALLEY, Aix-les-Bains, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity program after a balneotherapy

Behavioral

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

Primary outcomes

  1. Achievement of Physical activity recommendations

    Time frame: at 12 months of follow-up

    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.

Secondary outcomes

  1. Physical activity

    Time frame: at inclusion, 6 and 12 months of follow-up

    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)

  2. Weight

    Time frame: at inclusion, 6 and 12 months of follow-up

  3. Waist circumference

    Time frame: at inclusion, 6 and 12 months of follow-up

  4. Quality of life

    Time frame: at inclusion, 6 and 12 months of follow-up

    The quality of life will be measured thanks to the SF-12 questionnaire (Short Form Health Survey)

  5. Captured physical activity

    Time frame: at return home after the end of the balneotherapy, at 6 months and at 12 months of follow-up

    Physical activity will be measured thanks to accelerometers integrated into smartphones

Sponsors and collaborators

Lead sponsor

Association Francaise pour la Recherche Thermale

Other

Registry information

Official study 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

Acronym: THERMACTIVE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 1, 2016
Registry last updated
Jun 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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