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

Primary Purpose

Physical Activity, Chronic Diseases, Obesity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physical activity program after a balneotherapy
Sponsored by
Association Francaise pour la Recherche Thermale
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Physical Activity focused on measuring Web and smartphone-based physical activity program, Connected devices, Balneotherapy

Eligibility Criteria

50 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thermes CHEVALLEY
  • Centre thermal d'Amélie-les-Bains
  • Thermes de Bourbon-Lancy
  • Thermes de Brides-les-Bains
  • Caleden Complexe Thermal
  • Centre thermal d'Eugénie-les-Bains
  • Thermes du Boulou
  • Thermes de Vals-les-Bains
  • Thermes CALLOU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

Patients included in the control arm will receive a booklet including informations about physical activity recommendations and practice.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
Weight
Waist circumference
Quality of life
The quality of life will be measured thanks to the SF-12 questionnaire (Short Form Health Survey)
Captured physical activity
Physical activity will be measured thanks to accelerometers integrated into smartphones

Full Information

First Posted
February 18, 2016
Last Updated
June 28, 2018
Sponsor
Association Francaise pour la Recherche Thermale
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1. Study Identification

Unique Protocol Identification Number
NCT02694796
Brief Title
Impact of Web and Smartphone-based Physical Activity Program on Physical Activity Level 12 Months After a Balneotherapy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 20, 2017 (Actual)
Study Completion Date
December 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association Francaise pour la Recherche Thermale

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, Chronic Diseases, Obesity, Diabetes, Rheumatic Diseases, Cardiovascular Diseases, Breast Cancer, Chronic Obstructive Pulmonary Disease
Keywords
Web and smartphone-based physical activity program, Connected devices, Balneotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients included in the control arm will receive a booklet including informations about physical activity recommendations and practice.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity program after a balneotherapy
Intervention Description
workshop during the balneotherapy associated to an automated program of physical activity after the end of the balneotherapy available during 12 months
Primary Outcome Measure Information:
Title
Achievement of Physical activity recommendations
Description
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.
Time Frame
at 12 months of follow-up
Secondary Outcome Measure Information:
Title
Physical activity
Description
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)
Time Frame
at inclusion, 6 and 12 months of follow-up
Title
Weight
Time Frame
at inclusion, 6 and 12 months of follow-up
Title
Waist circumference
Time Frame
at inclusion, 6 and 12 months of follow-up
Title
Quality of life
Description
The quality of life will be measured thanks to the SF-12 questionnaire (Short Form Health Survey)
Time Frame
at inclusion, 6 and 12 months of follow-up
Title
Captured physical activity
Description
Physical activity will be measured thanks to accelerometers integrated into smartphones
Time Frame
at return home after the end of the balneotherapy, at 6 months and at 12 months of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine DUCLOS, MD-PhD
Organizational Affiliation
Centre Hospitalier Universitaire Gabriel Montpied, Clermont Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thermes CHEVALLEY
City
Aix-les-Bains
ZIP/Postal Code
73100
Country
France
Facility Name
Centre thermal d'Amélie-les-Bains
City
Amélie-les-Bains
ZIP/Postal Code
66110
Country
France
Facility Name
Thermes de Bourbon-Lancy
City
Bourbon Lancy
ZIP/Postal Code
71140
Country
France
Facility Name
Thermes de Brides-les-Bains
City
Brides-les-Bains
ZIP/Postal Code
73573
Country
France
Facility Name
Caleden Complexe Thermal
City
Chaudes-Aigues
ZIP/Postal Code
15110
Country
France
Facility Name
Centre thermal d'Eugénie-les-Bains
City
Eugénie-les-Bains
ZIP/Postal Code
40320
Country
France
Facility Name
Thermes du Boulou
City
Le Boulou
ZIP/Postal Code
66160
Country
France
Facility Name
Thermes de Vals-les-Bains
City
Vals-les-Bains
ZIP/Postal Code
07600
Country
France
Facility Name
Thermes CALLOU
City
Vichy
ZIP/Postal Code
03200
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26209025
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.
Results Reference
background
PubMed Identifier
21628005
Citation
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.
Results Reference
background
PubMed Identifier
23077157
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.
Results Reference
background
PubMed Identifier
26553211
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):e002239. doi: 10.1161/JAHA.115.002239.
Results Reference
background
PubMed Identifier
20558196
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.
Results Reference
background
PubMed Identifier
23470322
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.
Results Reference
background
PubMed Identifier
35708743
Citation
Fillol F, Paris L, Pascal S, Mulliez A, Roques CF, Rousset S, Duclos M. Possible Impact of a 12-Month Web- and Smartphone-Based Program to Improve Long-term Physical Activity in Patients Attending Spa Therapy: Randomized Controlled Trial. J Med Internet Res. 2022 Jun 16;24(6):e29640. doi: 10.2196/29640.
Results Reference
derived

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

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