NCT03785483

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 24, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

December 30, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

December 26, 2018

Status Verified

December 1, 2018

Enrollment Period

6 months

First QC Date

December 21, 2018

Last Update Submit

December 22, 2018

Conditions

MotivationMindfulness

Keywords

Physical activityMultiple sclerosisMotivationIntentionMindfulness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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.

  • 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.

  • 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.

  • 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.

Study Arms (3)

Motivation

EXPERIMENTAL

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

Mindfulness

ACTIVE COMPARATOR

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

Treatment as usual

NO INTERVENTION

Physical activity prescribe 120 minutes per week.

Interventions

MotivationBEHAVIORAL

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.

Also known as: Mindfulness
MindfulnessMotivation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult aged between 18 and 65 years
  • Multiple sclerosis
  • Recruited from CHU Poissy saint germain or Hôpital Raymond-Poincaré

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Raymond-Poincaré

Garches, 92380, France

RECRUITING

CHU Poissy Saint germain

Poissy, 78300, France

RECRUITING

MeSH Terms

Conditions

Motor ActivityMultiple Sclerosis

Interventions

Information Motivation Behavioral Skills ModelMindfulness

Condition Hierarchy (Ancestors)

BehaviorDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Models, PsychologicalModels, TheoreticalInvestigative TechniquesCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Emilie Dematte, MSc

    Paris Nanterre University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni De Marco, Pr

CONTACT

0033140975755demarco.giovanni@gmail.com

Jean F Fournier, PhD

CONTACT

0033140975639jean.fournier@u-paris10.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 3 groups: motivation, mindfulness, and treatment as usual
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 21, 2018

First Posted

December 24, 2018

Study Start

December 30, 2018

Primary Completion

June 15, 2019

Study Completion

June 30, 2019

Last Updated

December 26, 2018

Record last verified: 2018-12

Locations

FR(2)