Physical ActivityTHERMACTIVENCT02694796
Impact of Web and Smartphone-based Physical Activity Program on Physical Activity Level 12 Months After a Balneotherapy
A study testing Physical activity program after a balneotherapy in people with Physical Activity and Chronic Diseases, run by Association Francaise pour la Recherche Thermale at 9 sites in France.
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… Read more about this study
- Who is it for?
- Ages 50 to 79 years
- Conditions the study is for
- Physical Activity, Chronic Diseases, Obesity
- What is being tested?
- Physical activity program after a balneotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 9 sitesFrance
- Study dates
- Sep 2015to 20 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Thermes CHEVALLEY
Aix-les-Bains, 73100
Centre thermal d'Amélie-les-Bains
Amélie-les-Bains, 66110
Thermes de Bourbon-Lancy
Bourbon-Lancy, 71140
Thermes de Brides-les-Bains
Brides-les-Bains, 73573
Caleden Complexe Thermal
Chaudes-Aigues, 15110
Centre thermal d'Eugénie-les-Bains
Eugénie-les-Bains, 40320
Thermes du Boulou
Le Boulou, 66160
Thermes de Vals-les-Bains
Vals-les-Bains, 07600
Thermes CALLOU
Vichy, 03200
About this study
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
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.
Read the 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.
- Conditions
- Physical Activity, Chronic Diseases, Obesity, Diabetes, Rheumatic Diseases, Cardiovascular Diseases
- Being tested
- Physical activity program after a balneotherapy
- Keywords
- Web and smartphone-based physical activity program, Connected devices, Balneotherapy
- Medical subject headings
- Motor Activity, Chronic Disease, Obesity, Diabetes Mellitus, Rheumatic Diseases, Cardiovascular Diseases, Breast Neoplasms, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity program after a balneotherapyBehavioural
workshop during the balneotherapy associated to an automated program of physical activity after the end of the balneotherapy available during 12 months
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Physical activity program after a balneotherapy |
| Control | No intervention | Patients included in the control arm will receive a booklet including informations about physical activity recommendations and practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 12 months of follow-up
Secondary outcomes (5)
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)
Measured: at inclusion, 6 and 12 months of follow-up
Weight
Measured: at inclusion, 6 and 12 months of follow-up
Waist circumference
Measured: 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)
Measured: at inclusion, 6 and 12 months of follow-up
Captured physical activity
Physical activity will be measured thanks to accelerometers integrated into smartphones
Measured: at return home after the end of the balneotherapy, at 6 months and at 12 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startSep 2015
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Francaise pour la Recherche Thermale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martine DUCLOS, MD-PhD, Principal investigator, Centre Hospitalier Universitaire Gabriel Montpied, Clermont Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694796
- Sponsor's protocol ID
- C2015/02
- Acronym
- THERMACTIVE
- Status last verified
- Jun 2018
- First submitted
- 18 Feb 2016
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26209025Aalbers 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.
PubMed 21628005Ammann 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.
PubMed 23077157Martin 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.
PubMed 26553211Krebs 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.
PubMed 20558196Irvine 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.
PubMed 23470322Fillol 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.
PubMed 35708743
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02694796
- Acronym / sponsor ID
- THERMACTIVE / C2015/02
- Conditions
- Physical Activity, Chronic Diseases, Obesity, Diabetes, Rheumatic Diseases, Cardiovascular Diseases
- Keywords
- Web and smartphone-based physical activity program, Connected devices, Balneotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Association Francaise pour la Recherche ThermaleUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 1 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Physical activity program after a balneotherapyThe '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. |
| Control | No intervention | –Patients included in the control arm will receive a booklet including informations about physical activity recommendations and practice. |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity program after a balneotherapyworkshop during the balneotherapy associated to an automated program of physical activity after the end of the balneotherapy available during 12 months | Behavioural | Intervention |
Primary outcome
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.
5 secondary outcomes
Physical activity
Time frame: at inclusion, 6 and 12 months of follow-up
Weight
Time frame: at inclusion, 6 and 12 months of follow-up
Waist circumference
Time frame: at inclusion, 6 and 12 months of follow-up
Quality of life
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Background: PubMed 26209025van 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.
- Background: PubMed 21628005Aalbers 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.
- Background: PubMed 23077157Ammann 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.
- Background: PubMed 26553211Martin 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.
- Background: PubMed 20558196Krebs 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.
- Background: PubMed 23470322Irvine 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.
- Derived from this study: PubMed 35708743Fillol 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine DUCLOS, MD-PhD principal investigator
Centre Hospitalier Universitaire Gabriel Montpied, Clermont Ferrand
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity program after a balneotherapy in people with Physical Activity and Chronic Diseases, run by Association Francaise pour la Recherche Thermale at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of Physical activity recommendations (time frame: at 12 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02694796, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2018; AzTrials last refreshed its copy on 1 Nov 2026.