Implementation Intention for Physical Activity in Multiple Sclerosis

NCT ID: NCT03785483

Last Updated: 2018-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-30

Study Completion Date

2019-06-30

Brief Summary

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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

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Conditions

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Motivation Mindfulness

Keywords

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Physical activity Multiple sclerosis Motivation Intention Mindfulness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

3 groups: motivation, mindfulness, and treatment as usual
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Motivation

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

Group Type EXPERIMENTAL

Motivation

Intervention Type BEHAVIORAL

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.

Mindfulness

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).

Group Type ACTIVE_COMPARATOR

Motivation

Intervention Type BEHAVIORAL

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.

Treatment as usual

Physical activity prescribe 120 minutes per week.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Mindfulness

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CeRSM

UNKNOWN

Sponsor Role collaborator

COMUE

UNKNOWN

Sponsor Role collaborator

Poissy-Saint Germain Hospital

OTHER

Sponsor Role collaborator

Hôpital Raymond Poincaré

OTHER

Sponsor Role collaborator

Paris West University Nanterre La Défense

OTHER

Sponsor Role collaborator

Cite Sep

OTHER

Sponsor Role collaborator

University of Paris 5 - Rene Descartes

OTHER

Sponsor Role lead

Responsible Party

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Ruffault Alexis

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emilie Dematte, MSc

Role: PRINCIPAL_INVESTIGATOR

Paris Nanterre University

Locations

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Hôpital Raymond-Poincaré

Garches, , France

Site Status RECRUITING

CHU Poissy Saint germain

Poissy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Giovanni De Marco, Pr

Role: CONTACT

Phone: 0033140975755

Email: [email protected]

Jean F Fournier, PhD

Role: CONTACT

Phone: 0033140975639

Email: [email protected]

Facility Contacts

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Emilie Dematte, MSc

Role: primary

Emilie Dematte, MSc

Role: primary

Other Identifiers

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apsep-01

Identifier Type: -

Identifier Source: org_study_id