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Implementation Intention for Physical Activity in Multiple Sclerosis

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03785483
Acronym
apsep
Enrollment
45
Registered
2018-12-24
Start date
2018-12-30
Completion date
2019-06-30
Last updated
2018-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mindfulness, Motivation

Keywords

Physical activity, Multiple sclerosis, Motivation, Intention, Mindfulness

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.

Interventions

BEHAVIORALMotivation

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.

Sponsors

CeRSM
CollaboratorUNKNOWN
COMUE
CollaboratorUNKNOWN
Poissy-Saint Germain Hospital
CollaboratorOTHER
Hôpital Raymond Poincaré
CollaboratorOTHER
Paris West University Nanterre La Défense
CollaboratorOTHER
Cite Sep
CollaboratorOTHER
University of Paris 5 - Rene Descartes
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

3 groups: motivation, mindfulness, and treatment as usual

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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/

Countries

France

Contacts

Primary ContactGiovanni De Marco, Pr
demarco.giovanni@gmail.com0033140975755
Backup ContactJean F Fournier, PhD
jean.fournier@u-paris10.fr0033140975639

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026