Health BehaviorNCT03366701
Motivational Parameters Associated With Physical Activity and Sedentary Behaviors Among Persons With Chronic Diseases
An observational study of Health Behavior, run by 5 Santé at 1 site in France.
Trial summary
The principal aim of these researches is to explored the role of motivational parameters, including: automatic and controlled psychological processes and self-regulatory capacities, in physical activity and sedentary behaviors adoption and maintenance. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Health Behavior
- What is being tested?
- Rehabilitation
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to Jun 2017
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Person with chronic illness such cardio-respiratory and metabollic diseases
Who may be able to join
- Over 18 years old
- Under health care coverage
Who cannot join
- medical contra-indication to exercise
- concerned by acute health procedure
- enable to completed computerised tests and questionnaires
- Under psychiatric treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Automatic Psychological Processes, Self-regulatory Capacities and Physical Activity and Sedentary Behaviors Adoption, Change and Maintenance Among Persons With Chronic Diseases
The principal aim of these researches is to explored the role of motivational parameters, including: automatic and controlled psychological processes and self-regulatory capacities, in physical activity and sedentary behaviors adoption and maintenance. Precisely investigators are interested in change in motivational and self-regulatory processes during rehabilitation programs and their prospective influences on self-reported and objective behaviors among persons with chronic diseases.
Read the detailed description
Automatic processes refered to implicit attitudes measured through the implicit association test (IAT) and single category (SC-IAT). Controlled processes refered to the variables of the Theory of Planned Behavior measured by questionnaire. Self regulatory capacities refered to the concept of impulsivity measured by questionnaire and executive functions measured through the STROOP task and Wisconsin Card Sorting Task.
Physical activity and sedentary behaviors are measured by questionnaire and accelerometry.
- Conditions
- Health Behavior
- Being tested
- Rehabilitation
- Keywords
- physical activity, sedentary behavior, implicit attitudes, self regulation, intention, chronic diseases
- Medical subject headings
- Health Behavior, Motor Activity, Sedentary Behavior, Self-Control, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
The intervention (routine care) correspond to five weeks rehabilitation program
| Study group | Role | What they receive |
|---|---|---|
| Patient during rehabilitation program | Patient performing a 5 weeks inpatient pulmonary rehabilitation program Receives: Other: Rehabilitation | |
| Patient after the rehabilitation program | Patient in their domicile after the 5 weeks program Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective physical activity and sedentary behaviors
Objective physical activity and sedentary behaviors are measured with accelerometers. Time spent in sedentary behaviors (less than 1,5 Metabolic equivalents) ; light physical activity (1,5 to 3 Mets), moderate physical activities (3 to 6 Mets) and high intensities (up to 6 Mets) are recorded by the monitors.
Measured: This measure will be performed 6 months after the program during one week.
Secondary outcomes (6)
automatic psychological processes associated to physical activity and sedentary behaviors
Automatic processes : implicit association test (IAT, Greenwald et al., 1998). Reaction time and percentage of errors is using for the scoring procedure. The score is comprised between -2 and +2.
Measured: At the inclusion (T0)
controlled psychological processes associated to physical activity and sedentary behaviors
Controlled processes: variables of the Theory of Planned Behavior measured by questionnaire (Likert scale 1 to 7 point). 4 scores comprise between 1 to 7.
Measured: At the inclusion (T0)
Executive functions
Executive functions: the STROOP task and Wisconsin Card Sorting Task (WCST) design on computer. For the STROOP task a subtraction of the mean reaction time of two specifics blocks is computed (unity: millisecond). The WCST provide a score in percentage of errors.
Measured: At the inclusion (T0) and 6 months after
Self-regulatory capacities
Self-regulatory capacities: impulsivity measured by questionnaire, a score comprise between 20 (low score of impulsivity) and 80 is computed.
Measured: at the inclusion (T0)
Self-report sedentary behavior
Self-report Sedentary Behavior is measured by questionnaire. The score reflect a cumulative score in hour / week..
Measured: this measure will be performed 6 months after the program
Self-report physical activity
Self-report physical activity is measured by questionnaire. The scoring procedure requires to make the sum of the frequency by week (0 to 7days/weeks) with a score in minutes for those activities (1 point : less to 15 min ; 2 point : 16 to 30 ; 3 point : 31 to 60 ; 4 point : more than 60).
Measured: this measure will be performed 6 months after the program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study startMar 2015
- Primary completionMay 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- 5 Santé
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nelly HERAUD, Ph-D, Study director, 5 Santé
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366701
- Sponsor's protocol ID
- 5S_AUTAP
- Status last verified
- Dec 2017
- First submitted
- 30 Dec 2015
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Automatic Psychological Processes, Self-regulatory Capacities and Physical Activity and Sedentary Behaviors Adoption, Change and Maintenance Among Persons With Chronic Diseases
- ClinicalTrials.gov ID
- NCT03366701
- Acronym / sponsor ID
- 5S_AUTAP
- Conditions
- Health Behavior
- Keywords
- physical activity, sedentary behavior, implicit attitudes, self regulation, intention, chronic diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- 5 SantéUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 8 Dec 2017 (actual)
- 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 principal aim of these researches is to explored the role of motivational parameters, including: automatic and controlled psychological processes and self-regulatory capacities, in physical activity and sedentary behaviors adoption and maintenance. Precisely investigators are interested in change in motivational and self-regulatory processes during rehabilitation programs and their prospective influences on self-reported and objective behaviors among persons with chronic diseases.
Detailed description
Automatic processes refered to implicit attitudes measured through the implicit association test (IAT) and single category (SC-IAT). Controlled processes refered to the variables of the Theory of Planned Behavior measured by questionnaire. Self regulatory capacities refered to the concept of impulsivity measured by questionnaire and executive functions measured through the STROOP task and Wisconsin Card Sorting Task.
Physical activity and sedentary behaviors are measured by questionnaire and accelerometry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient during rehabilitation program | – | Other: RehabilitationPatient performing a 5 weeks inpatient pulmonary rehabilitation program |
| Patient after the rehabilitation program | – | Other: RehabilitationPatient in their domicile after the 5 weeks program |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Person with chronic illness such cardio-respiratory and metabollic diseases
Key inclusion criteria (2 listed)
- Over 18 years old
- Under health care coverage
Key exclusion criteria (4 listed)
- medical contra-indication to exercise
- concerned by acute health procedure
- enable to completed computerised tests and questionnaires
- Under psychiatric treatment
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 |
|---|---|---|
| RehabilitationThe intervention (routine care) correspond to five weeks rehabilitation program | Other | Patient after the rehabilitation program, Patient during rehabilitation program |
Primary outcome
Objective physical activity and sedentary behaviors
Time frame: This measure will be performed 6 months after the program during one week.
Objective physical activity and sedentary behaviors are measured with accelerometers. Time spent in sedentary behaviors (less than 1,5 Metabolic equivalents) ; light physical activity (1,5 to 3 Mets), moderate physical activities (3 to 6 Mets) and high intensities (up to 6 Mets) are recorded by the monitors.
6 secondary outcomes
automatic psychological processes associated to physical activity and sedentary behaviors
Time frame: At the inclusion (T0)
controlled psychological processes associated to physical activity and sedentary behaviors
Time frame: At the inclusion (T0)
Executive functions
Time frame: At the inclusion (T0) and 6 months after
Self-regulatory capacities
Time frame: at the inclusion (T0)
Self-report sedentary behavior
Time frame: this measure will be performed 6 months after the program
Self-report physical activity
Time frame: this measure will be performed 6 months after the program
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 8 Dec 2017.
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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.
Nelly HERAUD, Ph-D study director
5 Santé
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Behavior, run by 5 Santé at 1 site 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 2 inclusion and 4 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 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Objective physical activity and sedentary behaviors (time frame: This measure will be performed 6 months after the program during one week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2017.