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

June 28, 2018 updated by: Association Francaise pour la Recherche Thermale

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix-les-Bains, France, 73100
        • Thermes CHEVALLEY
      • Amélie-les-Bains, France, 66110
        • Centre thermal d'Amélie-les-Bains
      • Bourbon Lancy, France, 71140
        • Thermes de Bourbon-Lancy
      • Brides-les-Bains, France, 73573
        • Thermes de Brides-les-Bains
      • Chaudes-Aigues, France, 15110
        • Caleden Complexe Thermal
      • Eugénie-les-Bains, France, 40320
        • Centre thermal d'Eugénie-les-Bains
      • Le Boulou, France, 66160
        • Thermes du Boulou
      • Vals-les-Bains, France, 07600
        • Thermes de Vals-les-Bains
      • Vichy, France, 03200
        • Thermes CALLOU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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
workshop during the balneotherapy associated to an automated program of physical activity after the end of the balneotherapy available during 12 months
No Intervention: Control
Patients included in the control arm will receive a booklet including informations about physical activity recommendations and practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 12 months of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at inclusion, 6 and 12 months of follow-up
Weight
Time Frame: at inclusion, 6 and 12 months of follow-up
at inclusion, 6 and 12 months of follow-up
Waist circumference
Time Frame: at inclusion, 6 and 12 months of follow-up
at inclusion, 6 and 12 months of follow-up
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)
at inclusion, 6 and 12 months of follow-up
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
at return home after the end of the balneotherapy, at 6 months and at 12 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association Francaise pour la Recherche Thermale

Investigators

  • Principal Investigator: Martine DUCLOS, MD-PhD, Centre Hospitalier Universitaire Gabriel Montpied, Clermont Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

December 20, 2017

Study Completion (Actual)

December 20, 2017

Study Registration Dates

First Submitted

February 18, 2016

First Submitted That Met QC Criteria

February 29, 2016

First Posted (Estimate)

March 1, 2016

Study Record Updates

Last Update Posted (Actual)

June 29, 2018

Last Update Submitted That Met QC Criteria

June 28, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C2015/02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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