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Implementation Intention for Physical Activity in Multiple Sclerosis (apsep)

Primary Purpose

Motivation, Mindfulness

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Motivation
Sponsored by
University of Paris 5 - Rene Descartes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Motivation focused on measuring Physical activity, Multiple sclerosis, Motivation, Intention, Mindfulness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult aged between 18 and 65 years
  • Multiple sclerosis
  • Recruited from CHU Poissy saint germain or Hôpital Raymond-Poincaré
  • Informed consent provided during inclusion interview

Exclusion Criteria:

  • Already participating in a clinical trial
  • Cognitive dysfunctions in understanding simple guidelines
  • Treatment reducing fatigue since less than 3 months
  • Psychiatric disorders
  • Unability to exercise
  • Previous cardiovascular diseases
  • Regular physical activity practice

Sites / Locations

  • Hôpital Raymond-PoincaréRecruiting
  • CHU Poissy Saint germainRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Motivation

Mindfulness

Treatment as usual

Arm Description

Using implementation intention techniques such as action planning. Every week, participants state when, where, and what kind of prescribed exercises they will do.

10 minutes of audio recordings daily. Recordings contain: awareness of the breath, acceptation of thoughts and emotions, awareness of postures, awareness during stretching, awareness of a single movement (moving legs up while standing).

Physical activity prescribe 120 minutes per week.

Outcomes

Primary Outcome Measures

Change in physical activity
Accelerometer on a daily basis for 7 days

Secondary Outcome Measures

Change in self-reported anxiety and depression (HADS)
Hospital Anxiety and Depression Scale (2 subscales): anxiety (7 items) and depression (7 items) rated on a Likert-type scale ranging from 0 to 3. Total score for each subscale is the sum of each subscale's items. Higher scores indicate higher risks of anxiety and depression.
Change in self-reported mindfulness skills (FFMQ)
Five-Facets Mindfulness Questionnaire (5 subscales): observing, describing, non-judging, non-reacting, acting with awareness. Each subscale is composed of 3 items rated on a Likert-type scale ranging from 1 to 5. Total score for each subscale is the sum of each subscale's items. Total mindfulness score is the sum of all subscales' scores. Higher scores indicate higher mindfulness skills.
Change in self-reported motivational regulation toward exercise (BREQ)
Behavioral Regulation in Exercise Questionnaire (6 subscales): amotivation, external regulation, introjected regulation, integrated regulation, identified regulation, intrinsic regulation. Each subscale is composed of 3 items rated on a Likert-type scale ranging from 1 to 7. Total score for each subscale is the mean of each subscale's items. Higher scores indicate higher motivational regulation.
Change in self-reported beliefs toward physical activity (TPB).
Theory of Planned Behavior constructs (4 concepts): attitudes (5 items), subjective norm (4 items), perceived behavioral control (2 items), intentions (3 items). All items are rated on a Likert-type scale ranging from 1 to 7. Total score for each subscale is the mean of each subscale's items. Higher scores indicate higher beliefs toward physical activity/

Full Information

First Posted
December 21, 2018
Last Updated
December 22, 2018
Sponsor
University of Paris 5 - Rene Descartes
Collaborators
CeRSM, COMUE, Poissy-Saint Germain Hospital, Hôpital Raymond Poincaré, Paris West University Nanterre La Défense, Cite Sep
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1. Study Identification

Unique Protocol Identification Number
NCT03785483
Brief Title
Implementation Intention for Physical Activity in Multiple Sclerosis
Acronym
apsep
Official Title
Controlled Trial Testing the Effectiveness of Motivational Support on Physical Activity and Fatigue of Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 30, 2018 (Anticipated)
Primary Completion Date
June 15, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Paris 5 - Rene Descartes
Collaborators
CeRSM, COMUE, Poissy-Saint Germain Hospital, Hôpital Raymond Poincaré, Paris West University Nanterre La Défense, Cite Sep

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effectiveness of an 8-week intervention based on implementation intention (motivation) in patients with multiple sclerosis on objectively measured physical activity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motivation, Mindfulness
Keywords
Physical activity, Multiple sclerosis, Motivation, Intention, Mindfulness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 groups: motivation, mindfulness, and treatment as usual
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motivation
Arm Type
Experimental
Arm Description
Using implementation intention techniques such as action planning. Every week, participants state when, where, and what kind of prescribed exercises they will do.
Arm Title
Mindfulness
Arm Type
Active Comparator
Arm Description
10 minutes of audio recordings daily. Recordings contain: awareness of the breath, acceptation of thoughts and emotions, awareness of postures, awareness during stretching, awareness of a single movement (moving legs up while standing).
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Physical activity prescribe 120 minutes per week.
Intervention Type
Behavioral
Intervention Name(s)
Motivation
Other Intervention Name(s)
Mindfulness
Intervention Description
8 weeks of either action planning or mindfulness in addition to a treatment as usual which is a physical activity program of 120 minutes per week.
Primary Outcome Measure Information:
Title
Change in physical activity
Description
Accelerometer on a daily basis for 7 days
Time Frame
From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.
Secondary Outcome Measure Information:
Title
Change in self-reported anxiety and depression (HADS)
Description
Hospital Anxiety and Depression Scale (2 subscales): anxiety (7 items) and depression (7 items) rated on a Likert-type scale ranging from 0 to 3. Total score for each subscale is the sum of each subscale's items. Higher scores indicate higher risks of anxiety and depression.
Time Frame
From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.
Title
Change in self-reported mindfulness skills (FFMQ)
Description
Five-Facets Mindfulness Questionnaire (5 subscales): observing, describing, non-judging, non-reacting, acting with awareness. Each subscale is composed of 3 items rated on a Likert-type scale ranging from 1 to 5. Total score for each subscale is the sum of each subscale's items. Total mindfulness score is the sum of all subscales' scores. Higher scores indicate higher mindfulness skills.
Time Frame
From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.
Title
Change in self-reported motivational regulation toward exercise (BREQ)
Description
Behavioral Regulation in Exercise Questionnaire (6 subscales): amotivation, external regulation, introjected regulation, integrated regulation, identified regulation, intrinsic regulation. Each subscale is composed of 3 items rated on a Likert-type scale ranging from 1 to 7. Total score for each subscale is the mean of each subscale's items. Higher scores indicate higher motivational regulation.
Time Frame
From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.
Title
Change in self-reported beliefs toward physical activity (TPB).
Description
Theory of Planned Behavior constructs (4 concepts): attitudes (5 items), subjective norm (4 items), perceived behavioral control (2 items), intentions (3 items). All items are rated on a Likert-type scale ranging from 1 to 7. Total score for each subscale is the mean of each subscale's items. Higher scores indicate higher beliefs toward physical activity/
Time Frame
From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult aged between 18 and 65 years Multiple sclerosis Recruited from CHU Poissy saint germain or Hôpital Raymond-Poincaré Informed consent provided during inclusion interview Exclusion Criteria: Already participating in a clinical trial Cognitive dysfunctions in understanding simple guidelines Treatment reducing fatigue since less than 3 months Psychiatric disorders Unability to exercise Previous cardiovascular diseases Regular physical activity practice
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giovanni De Marco, Pr
Phone
0033140975755
Email
demarco.giovanni@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jean F Fournier, PhD
Phone
0033140975639
Email
jean.fournier@u-paris10.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie Dematte, MSc
Organizational Affiliation
Paris Nanterre University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Raymond-Poincaré
City
Garches
ZIP/Postal Code
92380
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie Dematte, MSc
Email
emilie.dematte@wanadoo.fr
Facility Name
CHU Poissy Saint germain
City
Poissy
ZIP/Postal Code
78300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie Dematte, MSc
Email
emilie.dematte@wanadoo.fr

12. IPD Sharing Statement

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Implementation Intention for Physical Activity in Multiple Sclerosis

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