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

N/ANot Yet RecruitingNCT07831928

University of Iowa118 enrolled

Overview

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.

Detailed Description Multiple sclerosis (MS) is a chronic neurodegenerative disease that affects nearly one million individuals in the United States. Progressive forms of the disease, including Primary Progressive Multiple Sclerosis (PPMS) and Secondary Progressive Multiple Sclerosis (SPMS), account for approximately 400,000 cases and are associated with substantial disability, fatigue, reduced quality of life, impaired mobility, mood disturbances, and cognitive challenges. Existing disease-modifying therapies have demonstrated effectiveness in reducing inflammatory disease activity but have limited impact on common disabling symptoms such as fatigue, anxiety, depression, and reduced health-related quality of life. Observational studies and preliminary intervention trials suggest that lifestyle factors, particularly diet quality, physical activity, and stress management practices, may improve symptoms and quality of life in people living with MS. However, high-quality randomized controlled trials evaluating integrated multimodal wellness interventions in individuals with progressive MS remain limited. This gap is particularly important because individuals with PPMS and SPMS often face barriers to in-person rehabilitation and wellness programs due to mobility limitations, transportation challenges, bowel and bladder dysfunction, and residence in rural communities. The purpose of the Evaluation of an Online, On demand Multimodal Wellness Program to Reduce Fatigue and Improve Quality of Life in Progressive Multiple Sclerosis: A Randomized Waitlist controlled Trial (DEW Study) is to evaluate the effectiveness of a fully online, on-demand multimodal wellness intervention designed to reduce fatigue and improve quality of life among adults with progressive multiple sclerosis with significant fatigue disability. The intervention combines dietary education, structured exercise programming, stress management training, and behavioral support delivered through accessible virtual platforms. The DEW intervention consists of three primary components: 1. Creating Health Online Wellness Course * Delivered through the University of Iowa Canvas platform. * Provides education regarding a modified Paleolithic dietary approach, with a Mediterranean dietary pathway available as an alternative. * Emphasizes increased intake of nutrient-dense foods, including vegetables, and reduction of ultra-processed foods. * Includes practical resources related to meal planning, cooking skills, behavior change, and self-management strategies. 2. MS Gym Online Exercise Program * A commercially available exercise platform specifically designed for individuals with multiple sclerosis. * Provides mobility-level specific aerobic, resistance, balance, and functional movement exercises. * Includes adaptations for seated and standing participation to accommodate varying levels of disability. 3. Stress Management Training o Participants are instructed in the 4-7-8 breathing technique, a structured breathing exercise intended to reduce stress and anxiety while supporting relaxation and sleep quality. Participants randomized to the intervention arm will also have access to monthly virtual group support sessions conducted via Zoom and facilitated by study personnel. These sessions utilize behavioral support and motivational interviewing principles to enhance adherence and self-efficacy. Participants may additionally communicate with the research team by email or text messaging for support throughout the intervention period. This study employs a randomized, waitlist-controlled design. Following informed consent, participants complete a 7-day run-in period designed to assess their ability to complete study procedures and baseline questionnaires. Participants who successfully complete baseline assessments will be randomized in a 1:1 ratio to either the intervention arm or a waitlist-control arm. Randomization is stratified by baseline fatigue severity. Participants assigned to the waitlist-control group will continue their usual diet, medical care, and lifestyle practices throughout the initial study period. They will receive general wellness information and monthly educational communications but will not have access to the wellness intervention during the primary comparison period. Following completion of the study assessments, waitlist participants will receive access to the Creating Health wellness course, the MS Gym exercise program, and a coaching session. Assessments are conducted electronically at baseline, Month 3, and Month 6 using validated patient-reported outcome measures. The primary outcome is change in fatigue severity, assessed using the Fatigue Severity Scale (FSS) at Month 3. Secondary outcomes include fatigue impact, health-related quality of life, mood, physical activity, dietary adherence, self-efficacy, social support, and participant acceptability of the intervention. Measures include the Modified Fatigue Impact Scale (MFIS), Multiple Sclerosis Quality of Life-54 (MSQOL-54), Hospital Anxiety and Depression Scale (HADS), Godin Leisure Time Exercise Questionnaire (GLTEQ), Physical Activity Vital Signs (PAVS), Mediterranean Diet Adherence Screener (MEDAS-14), Paleolithic Diet Adherence Screener (PDAS-12), Multiple Sclerosis Self-Efficacy Scale (MSSE), Multidimensional Scale of Perceived Social Support (MSPSS), Theoretical Framework of Acceptability questionnaire, and a Process Evaluation Questionnaire. The primary hypothesis is that participants receiving the DEW intervention will demonstrate greater improvements in fatigue at 3 months compared with participants receiving usual care. Secondary hypotheses are that intervention participants will experience improvements in quality of life, mood, physical activity, dietary adherence, self-efficacy, and perceived social support. Process evaluation measures will be used to identify barriers and facilitators to implementation and inform future dissemination of the intervention. By evaluating a scalable, fully virtual wellness program targeting fatigue and quality of life in progressive MS, this trial seeks to establish an accessible, non-pharmacologic approach that may help address important unmet needs among individuals living with progressive forms of multiple sclerosis

Eligibility

Sex: ALLMin age: 45 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Definitive diagnosis of Primary Progressive MS (PPMS) or Secondary Progressive MS (SPMS) based on the 2024 revised McDonald Criteria and confirmed by the treating neurologist who also approves participation. 2. Age 45 to 70 at the time of consent. 3. Must be fluent in both speaking and reading English. \*Study participant must be able to read and comprehend informed consent document and speak with study staff about study document content. Study staff will use discretion in determining whether the study participant can clearly communicate with staff and comprehend the study material during the consent call or prior to the call. 4. Fatigue Severity Scale (FSS) score of greater than or equal to 4. 5. Ability to prepare, or availability of someone in the household to prepare, home-cooked meals. 6. Willingness to commit to the study diet, 4-7-8 breathing technique, and a structured exercise program. 7. Access to high-speed internet with ownership of a device that can access the online programming and is capable of audio/video streaming. 8. Completion of online surveys at Month 0 (baseline), Month 3, \& Month 6. Exclusion Criteria: 1. Confirmation of taking insulin or coumadin. 2. Documentation of relapse during the prior 4 weeks. 3. Use of corticosteroids during the prior 4 weeks. 4. Change or initiation of Disease Modifying Treatment (DMT) during the prior 4 weeks. 5. Treatment for cancer by radiation or chemotherapy within the prior 12 months. 6. Diagnosis of clinically significant heart, liver, or kidney disease, or history of oxalate kidney stones. 7. Clinical diagnosis of psychiatric disease making study adherence difficult (e.g., schizophrenia) or an active eating disorder (anorexia, bulimia, binge eating, orthorexia). 8. Measurement of Body Mass Index (BMI) \< 19. 9. Initiation of or change in medication to treat mood disorders in the prior 12 weeks. 10. Documentation of moderate or severe mental impairment (greater than or equal to 5 errors) as measured by the validated Short Portable Mental Health Questionnaire (SPMHQ).

Outcomes

Primary Outcomes

Fatigue Severity Scale (FSS) Score

The Fatigue Severity Scale (FSS) is a 9-item patient-reported questionnaire that measures the impact and severity of fatigue on daily functioning. Participants rate each item on a scale from 1 (strongly disagree) to 7 (strongly agree). The total score is calculated as the mean of the 9 items. Higher scores indicate greater fatigue severity. An FSS score ≥4 is commonly used to identify clinically significant fatigue in multiple sclerosis

Time frame: Baseline to 3 months

Secondary Outcomes

Fatigue Severity Scale (FSS) Score

Time frame: Baseline to 6 months

Change in Modified Fatigue Impact Scale (MFIS) Score

The MFIS evaluates the impact of fatigue on physical, cognitive, and psychosocial functioning during the previous 4 weeks. Score Range: 0 to 84 Interpretation: Lower scores indicate less impact of fatigue. Higher scores indicate greater fatigue-related impairment. A decrease in score represents improvemen

Time frame: Baseline to month 3 and month 6.

Change in Multiple Sclerosis Quality of Life-54 (MSQOL-54) Physical Health Composite Score

The MSQOL-54 is a disease-specific quality-of-life measure that combines the SF-36 with MS-specific domains. The Physical Health Composite measures the impact of MS on physical functioning and health. Score Range: 0 to 100 Interpretation: Higher scores indicate better physical health-related quality of life. An increase in score represents improvement.