Implementation Intention for Physical Activity in Multiple Sclerosis

Not Applicable

• Conditions: Motivation; Mindfulness
• Interventions: Behavioral: Motivation

• 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

Study Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-21
• Study First Submitted QC: 2018-12-21
• Last Update Submitted: 2018-12-22
• Study First Posted: 2018-12-24
• Last Update Posted: 2018-12-26
• Study Start: 2018-12-30
• Primary Completion: 2019-06-15
• Study Completion: 2019-06-30

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

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in physical activity	From 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

Name	Time	Method
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)

CHU Poissy Saint germain; 🇫🇷 Poissy, France

Hôpital Raymond-Poincaré; 🇫🇷 Garches, France