ClinicalTrials.gg
CompletedNCT03366701Updated Dec 8, 2017

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

An observational study in Health Behavior, sponsored by 5 Santé. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-12-08.

Sponsored by 5 Santé · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
450
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Health Behavior

Keywords

  • physical activity
  • sedentary behavior
  • implicit attitudes
  • self regulation
  • intention
  • chronic diseases
03

In context

Health Behavior

967 studies on the registry are indexed under Health Behavior; 165 are open to participants now.

This study's enrollment of 450 is above the median of 219 across 131 observational studies indexed under Health Behavior.

Browse Health Behavior studies →

Lead sponsor

5 Santé is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Person with chronic illness such cardio-respiratory and metabollic diseases

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Over 18 years old
  • Under health care coverage

Exclusion criteria

Exclusion Criteria:

  • medical to exercise
  • concerned by acute health procedure
  • enable to completed computerised tests and questionnaires
  • Under psychiatric treatment
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
450 participants (actual)
Patient registry
No

Groups and cohorts

  • Patient during rehabilitation program

    Patient performing a 5 weeks inpatient pulmonary rehabilitation program

    Other: Rehabilitation

  • Patient after the rehabilitation program

    Patient in their domicile after the 5 weeks program

    Other: Rehabilitation

Interventions

  • OtherRehabilitation

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: This measure will be performed 6 months after the program during one week.

Secondary outcomes

  1. 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.

    Time frame: At the inclusion (T0)

  2. 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.

    Time frame: At the inclusion (T0)

  3. 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.

    Time frame: At the inclusion (T0) and 6 months after

  4. Self-regulatory capacities

    Self-regulatory capacities: impulsivity measured by questionnaire, a score comprise between 20 (low score of impulsivity) and 80 is computed.

    Time frame: at the inclusion (T0)

  5. Self-report sedentary behavior

    Self-report Sedentary Behavior is measured by questionnaire. The score reflect a cumulative score in hour / week..

    Time frame: this measure will be performed 6 months after the program

  6. 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).

    Time frame: this measure will be performed 6 months after the program

07

Study locations

1 site
  • Chevance
    Montpellier, Herault 34000, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2015 to primary completion in May 2016, 14 months.

Of 52 non-industry observational studies under Health Behavior, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 55. This study's 14 months is below that.

Counting every sponsor, half of 54 studies reached it within 22 months; a quarter within 4 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 30, 2015
First posted
Dec 8, 2017
StartActual
Mar 2015
Primary completionActual
May 2016
CompletionActual
Jun 2017
Last update
Dec 8, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03366701
Lead sponsor
5 Santé
Responsible party
Sponsor
First posted
Dec 8, 2017
Start date
Mar 2015
Primary completion
May 2016
Completion
Jun 2017
Last update
Dec 8, 2017

Study contacts

Nelly HERAUD, Ph-D
study director · 5 Santé

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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