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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03366701
Other study ID # 5S_AUTAP
Secondary ID
Status Completed
Phase N/A
First received December 30, 2015
Last updated December 4, 2017
Start date March 2015
Est. completion date June 2017

Study information

Verified date December 2017
Source 5 Santé
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 450
Est. completion date June 2017
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Over 18 years old

- Under health care coverage

Exclusion Criteria:

- medical contra-indication to exercise

- concerned by acute health procedure

- enable to completed computerised tests and questionnaires

- Under psychiatric treatment

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Rehabilitation
The intervention (routine care) correspond to five weeks rehabilitation program

Locations

Country Name City State
France Chevance Montpellier Herault

Sponsors (1)

Lead Sponsor Collaborator
5 Santé

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. This measure will be performed 6 months after the program during one week.
Secondary 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. At the inclusion (T0)
Secondary 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. At the inclusion (T0)
Secondary 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. At the inclusion (T0) and 6 months after
Secondary Self-regulatory capacities Self-regulatory capacities: impulsivity measured by questionnaire, a score comprise between 20 (low score of impulsivity) and 80 is computed. at the inclusion (T0)
Secondary Self-report sedentary behavior Self-report Sedentary Behavior is measured by questionnaire. The score reflect a cumulative score in hour / week.. this measure will be performed 6 months after the program
Secondary 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). this measure will be performed 6 months after the program
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