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

December 4, 2017 updated by: 5 Santé

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Herault
      • Montpellier, Herault, France, 34000
        • Chevance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Person with chronic illness such cardio-respiratory and metabollic diseases

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
This measure will be performed 6 months after the program during one week.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At the inclusion (T0)
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.
At the inclusion (T0)
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.
At the inclusion (T0) and 6 months after
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.
at the inclusion (T0)
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..
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
5 Santé

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Nelly HERAUD, Ph-D, 5 Santé

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5S_AUTAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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