Implementation Intention for Physical Activity in Multiple Sclerosis

Study Overview
=================
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.

Official Title
-----------------
Controlled Trial Testing the Effectiveness of Motivational Support on Physical Activity and Fatigue of Patients With Multiple Sclerosis

Conditions
-----------------
Motivation, Mindfulness

Intervention / Treatment
-----------------
* Behavioral: Motivation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 groups: motivation, mindfulness, and treatment as usual
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivation<br>Using implementation intention techniques such as action planning. Every week, participants state when, where, and what kind of prescribed exercises they will do. | Behavioral: Motivation<br>* 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.<br>* Other names: Mindfulness;|
| Active Comparator: Mindfulness<br>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). | Behavioral: Motivation<br>* 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.<br>* Other names: Mindfulness;|
| No Intervention: Treatment as usual<br>Physical activity prescribe 120 minutes per week. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical activity | Accelerometer on a daily basis for 7 days | From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up. | 
| 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. | From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up. | 
| 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. | From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up. | 
| 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/ | From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical activity, Multiple sclerosis, Motivation, Intention, Mindfulness