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Implementation Intention for Physical Activity in Multiple Sclerosis

Not Applicable
Conditions
Motivation
Mindfulness
Registration Number
NCT03785483
Lead Sponsor
University of Paris 5 - Rene Descartes
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
45
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change in physical activityFrom baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.

Accelerometer on a daily basis for 7 days

Secondary Outcome Measures
NameTimeMethod
Change in self-reported anxiety and depression (HADS)From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.

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)From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.

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)From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.

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).From baseline to 3 months follow-up. Assessments at baseline, post-intervention (8 weeks), and 3 months follow-up.

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/

Trial Locations

Locations (2)

Hôpital Raymond-Poincaré

🇫🇷

Garches, France

CHU Poissy Saint germain

🇫🇷

Poissy, France

Hôpital Raymond-Poincaré
🇫🇷Garches, France
Emilie Dematte, MSc
Contact
emilie.dematte@wanadoo.fr

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