NCT03366701

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
Last Updated

December 8, 2017

Status Verified

December 1, 2017

Enrollment Period

1.2 years

First QC Date

December 30, 2015

Last Update Submit

December 4, 2017

Conditions

Keywords

physical activitysedentary behaviorimplicit attitudesself regulationintentionchronic diseases

Outcome Measures

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.

    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

    At the inclusion (T0)

  • controlled psychological processes associated to physical activity and sedentary behaviors

    At the inclusion (T0)

  • Executive functions

    At the inclusion (T0) and 6 months after

  • Self-regulatory capacities

    at the inclusion (T0)

  • Self-report sedentary behavior

    this measure will be performed 6 months after the program

  • +1 more secondary outcomes

Study Arms (2)

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

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

Patient after the rehabilitation programPatient during rehabilitation program

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Person with chronic illness such cardio-respiratory and metabollic diseases

You may qualify if:

  • Over 18 years old
  • Under health care coverage

You may not qualify if:

  • medical contra-indication to exercise
  • concerned by acute health procedure
  • enable to completed computerised tests and questionnaires
  • Under psychiatric treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chevance

Montpellier, Herault, 34000, France

Location

MeSH Terms

Conditions

Health BehaviorMotor ActivitySedentary BehaviorSelf-ControlChronic Disease

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

BehaviorSocial BehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Nelly HERAUD, Ph-D

    5 Santé

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2015

First Posted

December 8, 2017

Study Start

March 1, 2015

Primary Completion

May 1, 2016

Study Completion

June 1, 2017

Last Updated

December 8, 2017

Record last verified: 2017-12

Locations