Running, not recruitingNot a drug-phase studyMS (type not specified)NCT06355804

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Physical activity condition
  • Waitlist condition

What it measured

Main measures

  • Physical Activity Behavior

    Changes in the GLTEQ scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)

    Physical function
  • Physical Activity Behavior

    Changes in the IPAQ scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)

    Physical function
  • Physical Activity Level (Light physical activity)

    Changes in time spent in LPA from Baseline (pre-intervention) and after 16 weeks (post-intervention)

    Physical function
  • Physical Activity Level (Moderate-to-vigorous physical activity)

    Changes in time spent in MVPA from Baseline (pre-intervention) and after 16 weeks (post-intervention)

    Physical function
  • Physical Activity Level (Daily step count)

    Changes in time spent in daily step count from Baseline (pre-intervention) and after 16 weeks (post-intervention)

    Physical function

Other measures (5)

  • Health-related quality of Life

    Changes in SF-12 scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)

    Quality of life (reported by participants)
  • Health-related Quality of Life

    Changes in MSIS-29 scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)

    Quality of life (reported by participants)
  • Fatigue Severity

    Changes in fatigue severity scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)

    Fatigue
  • Depressive Symptoms

    Changes in depressive symptoms scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)

    Mood and sleep
  • Anxiety

    Changes in anxiety scores from Baseline (pre-intervention) and after 16 weeks (post-intervention)

    Mood and sleep

Who could take part

MS (type not specified) · 18 and over

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 primary language * internet and e-mail access, and willingness to complete the testing and questionnaires * ambulatory without an assistive device (e.g., cane) * insufficiently active (Godin Leisure-Time Exercise Questionnaire (GLTEQ) \< 14) * visual ability and literacy to read newsletter with font size 14 points * on a disease-modifying therapy. Exclusion Criteria: * pregnant * have 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.

About this trial

In the sponsor's words

The overall objective of the current study is to determine the efficacy of a 16-week remotely delivered lifestyle behavioral intervention compared with a control condition (i.e., waitlist control) in persons newly diagnosed with MS (disease duration ≤ 2 years). Specific Aim 1: To evaluate the changes in self-report and device-measured physical activity after the 16-week remotely delivered physical activity behavior change intervention compared with a control condition (i.e., waitlist control) in persons who have diagnosed with MS within the past two years. The investigators hypothesize that the 16-week behavior change intervention will yield greater improvements in physical activity levels than the control condition immediately after the intervention. Specific Aim 2: To investigate the efficacy of the 16-week, remotely delivered physical activity behavior change intervention compared with the control condition for improvements in fatigue, depression, anxiety, and QoL in persons newly diagnosed with MS. The investigators hypothesize that there will be beneficial effects on the symptoms and QoL outcomes immediately after the physical activity intervention compared with minimal changes in the control condition.

Papers

Loading reviews and guidelines…

History

    1. Started

      Apr 2024

    2. Main results due

      Aug 2026

    3. Finished

      Dec 2026

    Assembled by software from public sources and not checked by people. Each record links to its source. Report an error