Implementation Intention for Physical Activity in Multiple Sclerosis

Mindfulness Clinical Trial

— apsep  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03785483
• Other study ID #: apsep-01
• Status: Recruiting
• Phase: N/A
• Start date: December 30, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: December 2018
• Source: University of Paris 5 - Rene Descartes
• Contact: Giovanni De Marco, Pr
• Phone: 0033140975755
• Email: demarco.giovanni[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 30, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Mindfulness
• Motivation
• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Motivation
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.

Locations

Country	Name	City	State
France	Hôpital Raymond-Poincaré	Garches
France	CHU Poissy Saint germain	Poissy

Sponsors (7)

Lead Sponsor	Collaborator
University of Paris 5 - Rene Descartes	CeRSM, Cite Sep, COMUE, Hôpital Raymond Poincaré, Paris West University Nanterre La Défense, Poissy-Saint Germain Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.