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Physical Activity Intervention for Individuals Newly Diagnosed With MS (ActivNMS)

25. Juli 2026 aktualisiert von: Robert W Motl, University of Illinois at Chicago

Physical Activity Behavior Change Intervention in Persons Newly Diagnosed With Multiple Sclerosis - ActivNMS Trial - COM-B Construct Testing

The proposed study is a parallel-group randomized controlled trial (RCT) designed to establish the behavioral mechanism underlying a 16-week physical activity (PA) behavioral intervention through its effects on the Capability-Opportunity-Motivation-Behavior (COM-B) constructs. The success of this study will provide robust evidence for supporting its refinement via refined COM-B constructs and Behavior Change Techniques to facilitate or maximize the intervention effects on PA levels, which will be examined in the subsequent clinical trial. Such an approach will involve an RCT that examines the effects of a 16-week remotely delivered, Internet-based PA behavioral intervention via video behavioral coaching and newsletter compared with a waitlist control (WLC) condition for yielding improvements in the COM-B constructs among persons newly diagnosed with multiple sclerosis (PNDwMS, disease duration ≤ 2 years). The investigators hypothesize that participants in the PA behavioral intervention condition will demonstrate greater improvements in the COM-B constructs than those in the WLC condition. The investigators plan to recruit 50 PNDwMS, with a distribution of 25 participants in the PA behavioral intervention and 25 participants in the WLC condition. The primary outcomes are the self-report COM-B constructs (listed in the Outcomes section), which will be remotely assessed at baseline and post-intervention through an online battery of questionnaires via REDCap.

Specific Aim 1: to establish mechanisms for the behavior change intervention using a 2-arm pilot randomized controlled trial (RCT) of the intervention compared with the waitlist control (WLC) among PNDwMS. The investigators hypothesize that the 16-week COM-B-based behavioral intervention delivered by one-on-one behavior coaching and newsletters will result in larger changes in COM-B constructs (i.e., knowledge, outcome expectations, goal, intention, behavioral regulation, self-efficacy, fatigue, social support, and social and environmental barriers) than in the WLC group.

Specific Aim 2: to examine change in self-reported physical activity levels in PNDwMS who received the COM-B-based intervention compared with those who are in the waitlist control condition. The investigators hypothesize that the 16-week COM-B-based behavioral intervention will result in larger changes in self-reported physical activity outcomes than in the WLC group.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Multiple sclerosis (MS) is a prevalent neurological disease of the central nervous system that is the leading cause of neurological disability among young adults in the United States. This disease results in the progressive loss of walking, substantial worsening of cognition, symptoms of fatigue, as well as compromised quality of life (QoL). There is evidence that physical activity is beneficially associated with walking mobility, cognitive function, symptoms of fatigue, depression, anxiety, and pain in persons with MS. Nonetheless, this population is strikingly sedentary and physically inactive, including persons newly diagnosed with MS (diagnosed with MS for two years or less). Indeed, approximately 40% of persons with MS reported stopping physical activity after an MS diagnosis, and persons recently diagnosed with MS have not been included in physical activity intervention research. Yet, the early stage of MS represents an ideal time point for initiating physical activity for life-long benefits. There is further evidence that physical activity and exercise interventions delivered remotely can yield benefits in managing MS symptoms and comorbidities, and disability progression. In this study, the investigators aim to primarily test the effect of a 16-week remotely delivered behavioral intervention, compared with a control condition (i.e., waitlist control), on the psychological constructs based on the Capability-Opportunity-Motivation-Behavior model in persons newly diagnosed with MS (disease duration ≤ 2 years). Consequently, this could provide more evidence for the understanding of the intervention mechanism on physical activity behavior in people newly diagnosed with MS. Participants will complete a battery of questionnaires remotely over the internet before and immediately after the 16-week program. The first assessments occur upon enrollment in the study (Baseline Assessment) and the second occurs right after the intervention (16- week Assessment). In this study, participants will be randomly assigned into 1 of 2 conditions: a physical activity condition (receive the intervention immediately after baseline assessment) or a waitlist condition (receive the intervention after the 16-week assessment). Participants in both conditions will receive access to an Internet delivered program for 16 weeks as well as one-on-one coaching through Zoom. The participants could opt in/out of receiving the intervention after the follow-up assessment. The investigators will ask that participants in the physical activity condition wear a Fitbit (this is different from the accelerometer) for tracking physical activity daily during the 16- week period. The investigators will further ask that information from the Fitbit be recorded into a logbook daily.

Studientyp

Interventionell

Einschreibung (Geschätzt)

50

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60612
        • University of Illinois Chicago
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • aged 18 years or older
  • self-reported diagnosis of MS by a neurologist within the past 2 years
  • relapse-free for the past 30 days
  • ability to speak and read English as the primary language
  • internet and e-mail access
  • willingness to complete study protocol
  • ambulatory without an assistive device (PDDS < 3)
  • insufficiently active (Godin Leisure-Time Exercise Questionnaire (GLTEQ) < 14)
  • visual ability and literacy to read newsletter with font size 14 points
  • on a stable disease-modifying therapy for 6 months

Exclusion Criteria:

  • pregnant
  • have an elevated risk for undertaking strenuous or maximal exercise based on two or more affirmatives on the Physical Activity Readiness Questionnaire (PAR-Q)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Wartelistenkontrolle
Experimental: Treatment
COM-B-based Physical Activity Behavior Intervention
Verhalten: COM-B-based Physical Activity Behavior Change Intervention

Participants will receive a remote-delivered physical activity program for 16 weeks that includes access to electronic newsletters and regular chats over Zoom with a behavioral coach:

The newsletters provide behavioral strategies such as information on the benefits of physical activity, goal setting and monitoring, for increasing and maintaining physical activity levels.

Throughout the 16-week period, the investigators will ask participants to wear a Fitbit and record step count into a logbook daily for tracking physical activity.

The newsletter will be emailed to participants weekly throughout the program. The newsletters include knowledge, skills, and resources related to physical activity in the early stages of MS.

The program also involves 7 1-on-1 coaching chats with a coach to guide participants through the program and navigate challenges. These chats are conducted over Zoom and generally last about 15 - 30 minutes each. These sessions will not be recorded.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Knowledge and Information Provision Questionnaire (NIP)
Zeitfenster: Baseline and week 16

The Knowledge and Information Provision questionnaire will be administered remotely for self-report assessment of knowledge about physical activity.

3 items; Likert scale 1 - 4 (No - Yes, comprehensively)
Baseline and week 16
Multidimensional Outcome Expectations for Exercise Scale (MOEES)
Zeitfenster: Baseline and week 16

The MOEES will be administered remotely for self-report assessment of outcome expectations for physical activity/exercise.

15 items; Likert scale 1 - 5 (Strongly disagree - Strongly agree)
Baseline and week 16
Behavioral Intention
Zeitfenster: Baseline and week 16

The behavioral intention will be administered remotely for physical activity behavioral intentions.

5 items; Likert scale 1- 4 (Not true - Completely true)
Baseline and week 16
Exercise Goal Setting Scale (EGS)
Zeitfenster: Baseline and week 16
The EGS will be administered remotely to capture goal-setting skills. It includes 10 items rates on a Likert scale with anchors of 1 (Does not describe) and 5 (Describes completely)
Baseline and week 16
Behavioral Regulation Action Planning (BRAP) Subscale
Zeitfenster: Baseline and week 16
The BRAP will be administered remotely for capturing the action planning construct. 5 items; Likert scale 1 - 4 (Not true - Completely true)
Baseline and week 16
Behavioral Regulation Action Control (BRAC) Subscale
Zeitfenster: Baseline and week 16
The BRAC will be administered remotely for capturing the action control construct. 6 items; Likert scale 1 - 4 (Not true - Completely true)
Baseline and week 16
HAPA Self-efficacy Subscales (Action, Recovery, Maintenance Subscale)
Zeitfenster: Baseline and week 16
The Self-efficacy subscales will be administered remotely for capturing the self-efficacy levels in physical activity action, recovery, and maintenance. 9 items; Likert scale 1 - 4 (Not true - Exactly true)
Baseline and week 16
Hamburg Quality of Life Questionnaire Multiple Sclerosis - Fatigue Subscale (HAQUAMSF)
Zeitfenster: Baseline and week 16
The HAQUAMSF will be administered remotely for measuring fatigue 4 items; Likert scale 1 - 5 (Not at all - Very much)
Baseline and week 16
The PA-Related Social Support Scale (PASS)
Zeitfenster: Baseline and week 16
The PA-Related Social Support Scale will be administered remotely for capturing physical activity social support 7 items; Likert scale 1 - 4 (Almost never - Almost always)
Baseline and week 16
The Physical and Social Environment Barriers - Self-developed questionnaire
Zeitfenster: Baseline and week 16

The Physical and Social Environment Barriers will be administered remotely for capturing barriers in physical and social environment.

9 items; Likert scale 1 - 4 (Is not applicable - Applicable)
Baseline and week 16

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Physical Activity Behavior
Zeitfenster: Baseline and week 16
Godin Leisure-Time Exercise Questionnaire (GLTEQ); scores range between 0 (min) and 119 (max), higher scores indicate greater engagement in physical activity behavior.
Baseline and week 16
Physical Activity Behavior
Zeitfenster: Baseline and week 16
International Physical Activity Questionnaire (IPAQ); scores range between 0 (min) and 107 (max), higher scores indicate greater engagement in physical activity behavior.
Baseline and week 16
Formative Evaluation
Zeitfenster: Week 16
Self-report survey to assess participant satisfaction and collect feedback from participant.
Week 16

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Demographic information
Zeitfenster: Baseline
Self-report questionnaire will be administered remotely to capture age, sex, race, ethnicity, education, marital status, income
Baseline
Clinical characteristics
Zeitfenster: Baseline and week 16
Self-report questionnaire will be administered remotely to capture MS type, disease duration, Patient Determined Disease Steps (PDDS)
Baseline and week 16

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Illinois at Chicago

Ermittler

  • Hauptermittler: Robert Motl, PhD, University of Illinois at Chicago

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

1. Oktober 2028

Studienabschluss (Geschätzt)

1. Oktober 2028

Studienanmeldedaten

Zuerst eingereicht

22. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Juli 2026

Zuerst gepostet (Tatsächlich)

28. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • STUDY2026-0787

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Individual participant data will not be shared. The data will be analyzed after follow-up data collection, and findings will be published on scientific journals

IPD-Sharing-Zeitrahmen

Pre-enrollment on ClinicalTrials.gov

IPD-Sharing-Zugriffskriterien

No Criterial for access

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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