Physical Activity Intervention for Individuals Newly Diagnosed With MS

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

Not yet recruitingNot a drug-phase studyMS (type not specified)NCT07731659

What it found

Still running

No result yet.

What was tested

Treatment tested

  • COM-B-based Physical Activity Behavior Change Intervention

What it measured

Main measures

  • Knowledge and Information Provision Questionnaire (NIP)

    Baseline and week 16

    VisionPhysical function

  • Multidimensional Outcome Expectations for Exercise Scale (MOEES)

    Baseline and week 16

    Physical function

  • Behavioral Intention

    Baseline and week 16

    Physical function

  • Exercise Goal Setting Scale (EGS)

    Baseline and week 16

    Physical function

  • Behavioral Regulation Action Planning (BRAP) Subscale

    Baseline and week 16

  • Behavioral Regulation Action Control (BRAC) Subscale

    Baseline and week 16

  • HAPA Self-efficacy Subscales (Action, Recovery, Maintenance Subscale)

    Baseline and week 16

    Physical function

  • Hamburg Quality of Life Questionnaire Multiple Sclerosis - Fatigue Subscale (HAQUAMSF)

    Baseline and week 16

    FatigueQuality of life (reported by participants)

  • The PA-Related Social Support Scale (PASS)

    Baseline and week 16

    Physical function

  • The Physical and Social Environment Barriers - Self-developed questionnaire

    Baseline and week 16

Other measures (2)

  • Physical Activity Behavior

    Baseline and week 16

    Physical function

  • Formative Evaluation

    Week 16

    Quality of life (reported by participants)

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

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)

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

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History

    1. Started

      Oct 2026

    2. Main results due

      Oct 2028

    3. Finished

      Oct 2028

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