Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Motivational Parameters Associated With Physical Activity and Sedentary Behaviors Among Persons With Chronic Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03366701
Recruitment Status : Completed
First Posted : December 8, 2017
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
5 Santé

Brief 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.

Condition or disease Intervention/treatment
Health Behavior Other: Rehabilitation

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : March 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2017


Group/Cohort Intervention/treatment
Patient during rehabilitation program
Patient performing a 5 weeks inpatient pulmonary rehabilitation program
Other: Rehabilitation
The intervention (routine care) correspond to five weeks rehabilitation program

Patient after the rehabilitation program
Patient in their domicile after the 5 weeks program
Other: Rehabilitation
The intervention (routine care) correspond to five weeks rehabilitation program




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. automatic psychological processes associated to physical activity and sedentary behaviors [ Time Frame: At the inclusion (T0) ]
    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.

  2. controlled psychological processes associated to physical activity and sedentary behaviors [ Time Frame: At the inclusion (T0) ]
    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.

  3. Executive functions [ Time Frame: At the inclusion (T0) and 6 months after ]
    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.

  4. Self-regulatory capacities [ Time Frame: at the inclusion (T0) ]
    Self-regulatory capacities: impulsivity measured by questionnaire, a score comprise between 20 (low score of impulsivity) and 80 is computed.

  5. Self-report sedentary behavior [ Time Frame: this measure will be performed 6 months after the program ]
    Self-report Sedentary Behavior is measured by questionnaire. The score reflect a cumulative score in hour / week..

  6. Self-report physical activity [ Time Frame: this measure will be performed 6 months after the program ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Person with chronic illness such cardio-respiratory and metabollic diseases
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03366701


Locations
Layout table for location information
France
Chevance
Montpellier, Herault, France, 34000
Sponsors and Collaborators
5 Santé
Investigators
Layout table for investigator information
Study Director: Nelly HERAUD, Ph-D 5 Santé
Layout table for additonal information
Responsible Party: 5 Santé
ClinicalTrials.gov Identifier: NCT03366701    
Other Study ID Numbers: 5S_AUTAP
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
Keywords provided by 5 Santé:
physical activity
sedentary behavior
implicit attitudes
self regulation
intention
chronic diseases
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Disease
Disease Attributes
Pathologic Processes