Evaluation of an Online, On Demand Multimodal Wellness Program to Reduce Fatigue and Improve Quality of Life in Progressive Multiple Sclerosis.

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
University of Iowa
Study ID
NCT07831928
Status
Not Yet Recruiting

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Conditions

  • Primary Progressive Multiple Sclerosis (PPMS)
  • Secondary Progressive Multiple Sclerosis (SPMS)

Eligibility Criteria

Sex
ALL
Age
45 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Online wellness course and online exercise platform — BEHAVIORAL
    An online wellness course that teaches participants about behavior change, nutrition, exercise, stress management, and other wellness behaviors. Also includes access to an online exercise platform.
  • Usual Care Group — OTHER
    Participant will continue with their usual diet and wellness behaviors.

Study Details

The goal of this clinical trial is to learn if an online wellness program can lower fatigue and improve mood and quality of life in people with progressive multiple sclerosis who are 45 to 70 years old and are experiencing significant fatigue disability. The main questions it aims to answer are: * Does the online wellness program lower fatigue after 3 months and further lower fatigue after 6 months? * Does the online wellness program improve anxiety, depression, and quality of life after 3 months and lead to additional improvements after 6 months? Researchers will compare participants who receive immediate access to the online wellness program with participants who continue their usual care and receive access to the program after the study ends. Participants will: * Complete online surveys at the start of the study, at 3 months, and at 6 months. Each survey session takes less than 1 hour. * Complete a 7-day run-in period before randomization to confirm their interest and ability to complete study activities. * Be assigned by chance to either the online wellness program group or the wait-list control group. Participants in the online wellness program group will: * Receive access to the "Creating Health" online course through the University of Iowa Canvas platform. * Work through five self-paced education modules over 6 months. Topics include nutrition, stress management, and physical activity. * Have access to monthly group coaching calls by Zoom. * Have access to an online exercise platform. * Have access to email and text support from the study team. Participants in the wait-list control group will: * Continue their usual diet, lifestyle, and medical care during the 6-month study period. * Complete the same study surveys as the intervention group. * Receive full access to the online wellness program, online exercise platform and support materials after completing their final 6-month surveys. At the end of the study, all participants will complete final surveys about their symptoms, quality of life, and their experience with the program. Active study participation ends after the 6-month assessments are completed.

Key Dates

First listed
Sep 21, 2026
Start date
Nov 15, 2026
Status verified
Sep 2026
Primary completion
Nov 15, 2029
Completion
Dec 15, 2030

Study Design

Enrollment
118 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention arm
    Wellness online program and virtual exercise platform
  • Placebo Comparator: Waitlist control
    Continues with usual care as directed by their neurologist

Primary Outcome Measure

Fatigue Severity Scale (FSS) Score [ Time Frame: Baseline to 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UI Health CareIowa CityIowa52242.-

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By research site
UI Health Care· Iowa City, IA

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