An interventional study of Online wellness course and online exercise platform and Usual Care Group in Primary Progressive Multiple Sclerosis (PPMS) and Secondary Progressive Multiple Sclerosis (SPMS), sponsored by University of Iowa. Not yet recruiting at 1 site in United States. Open to participants aged 45 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by University of Iowa · Not applicable, Interventional, and Treatment
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:
Participants will:
Participants in the online wellness program group will:
Participants in the wait-list control group will:
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. 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.
244 studies on the registry are indexed under Multiple Sclerosis, Chronic Progressive; 53 are open to participants now.
This study's planned enrollment of 118 is above the median of 54 across 189 interventional studies indexed under Multiple Sclerosis, Chronic Progressive.
Browse Multiple Sclerosis, Chronic Progressive studies →University of Iowa is the lead sponsor of 279 studies on the registry; 33 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 40 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Must be fluent in both speaking and reading English.
*Study participant must be able to read and comprehend 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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Wellness online program and virtual exercise platform
Behavioral: Online wellness course and online exercise platform
Continues with usual care as directed by their neurologist
Other: Usual Care Group
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.
Participant will continue with their usual diet and wellness behaviors.
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
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 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.
Time frame: Baseline to month 3 and month 6
Change in MSQOL-54 Mental Health Composite Score
The Mental Health Composite of the MSQOL-54 assesses emotional well-being, cognitive health, social functioning, and mental health status. Score Range: 0 to 100 Interpretation: Higher scores indicate better mental health-related quality of life. An increase in score represents improvement
Time frame: Baseline to month 3 and month 6
Change in Hospital Anxiety and Depression Scale Anxiety Subscale (HADS-A)
The HADS-A is a 7-item patient-reported measure assessing symptoms of anxiety. Score Range: 0 to 21 Interpretation: Lower scores indicate fewer anxiety symptoms. Higher scores indicate greater anxiety. A decrease in score represents improvement. Severity Categories: 0-7: Normal 8-10: Borderline abnormal 11-21: Clinically significant anxiety
Time frame: Baseline to month 3 and month 6
Change in Hospital Anxiety and Depression Scale Depression Subscale (HADS-D) Score
The HADS-D is a 7-item patient-reported measure assessing symptoms of depression. Score Range: 0 to 21 Interpretation: Lower scores indicate fewer depressive symptoms. Higher scores indicate greater depression. A decrease in score represents improvement. Severity Categories: 0-7: Normal 8-10: Borderline abnormal 11-21: Clinically significant depression
Time frame: Baseline to month 3 and month 6
Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ) Score
The GLTEQ measures the frequency of mild, moderate, and strenuous leisure-time physical activity performed during a typical week. Score Range: 0 to approximately 119+ (no fixed upper limit) Interpretation: Higher scores indicate greater participation in physical activity. An increase in score represents improvement
Time frame: Baseline to month 3 and month 6
Change in Physical Activity Vital Sign (PAVS) Weekly Minutes of Moderate-to-Vigorous Physical Activity
The PAVS estimates the number of minutes per week spent engaging in moderate-to-vigorous physical activity. Score Range: 0 minutes to no fixed upper limit Interpretation: Higher values indicate greater physical activity participation. An increase in weekly minutes represents improvement
Time frame: Baseline to month 3 and month 6
Change in Mediterranean Diet Adherence Screener (MEDAS-14) Score
The MEDAS-14 assesses adherence to a Mediterranean dietary pattern using 14 dietary behavior questions. Score Range: 0 to 14 Interpretation: Higher scores indicate greater adherence to a Mediterranean diet. An increase in score represents improvement.
Time frame: Baseline to month 3 and month 6
Change in Paleolithic Diet Adherence Screener (PDAS-12) Score
The PDAS-12 assesses adherence to a Paleolithic dietary pattern based on 12 dietary criteria. Score Range: 0 to 12 Interpretation: Higher scores indicate greater adherence to a Paleolithic diet. An increase in score represents improvement
Time frame: Baseline to month 3 and month 6
Change in Multiple Sclerosis Self-Efficacy Scale (MSSE) Score
The MSSE assesses a participant's confidence in managing symptoms and daily challenges associated with multiple sclerosis. Score Range: 14 to 84 Interpretation: Higher scores indicate greater self-efficacy. An increase in score represents improvement
Time frame: Baseline to month 3 and month 6
Change in Multidimensional Scale of Perceived Social Support (MSPSS) Score
The MSPSS is a 12-item questionnaire that measures perceived social support from family, friends, and significant others. Score Range: 12 to 84 Interpretation: Higher scores indicate greater perceived social support. An increase in score represents improvement
Time frame: Baseline to month 3 and month 6
Patient Determined Disease Steps (PDDS) Score
The PDDS is a patient-reported measure of disability status in multiple sclerosis that correlates with the Expanded Disability Status Scale (EDSS). Score Range: 0 to 8 Interpretation: 0 = Normal 8 = Bedridden Lower scores indicate less disability. A decrease in score represents improvement
Time frame: Baseline to month 3 and month 6
Theoretical Framework of Acceptability (TFA) Questionnaire
The TFA Questionnaire evaluates participant perceptions of intervention acceptability, including burden, perceived effectiveness, ethicality, self-efficacy, and overall satisfaction. Score Range: 1 to 5 per item (summary score calculated as mean response) Interpretation: Higher scores indicate greater acceptability of the intervention.
Time frame: At study conclusion (month 6)
Process Evaluation Questionnaire (PEQ)
The PEQ is a study-specific questionnaire used to identify facilitators and barriers to participation, as well as participant experiences with intervention delivery and adherence. Score Range: Varies by item Interpretation: Descriptive measure used to assess implementation, feasibility, and participant feedback. Higher scores on scaled items generally indicate more favorable perceptions of the intervention.
Time frame: At study conclusion (month 6)
Plan to share: Yes — After publication of results, relevant IPD published data will be shared for scientists who are conducting meta-analyses with a published protocol for PROSPERO registered meta-analysis.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: The IPD would be available one year after the primary outcomes data has been published.
Access criteria: Scientists with an academic appointment who wish to use IPD in a meta-analysis registered with Prospero and have published their protocol for the proposed meta-analyses are eligible to request access to the data. Proposals requesting access to the data should include the published protocol for the proposed meta-analysis and which specific data elements are being requested. The scientist should reach out to the study PI via their academic email with the requested documents. The scientists will provide their name, email, phone number and physical address at their institution. After reviewing the proposed meta-analysis and approval of the request by the PI, an outgoing material transfer agreement will be initiated by the PI via the University of Iowa Department of Sponsored Programs outlining terms of the data use. Upon completion of the data use agreement, the method of transfer of data elements will be mutually determined.
Start is estimated for Nov 2026; primary completion for Nov 2029, 36 months later.
Of 35 non-industry interventional studies with no phase under Multiple Sclerosis, Chronic Progressive, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 44. This study's planned 36 months is close to that.
Counting every sponsor, half of 36 studies reached it within 33 months; a quarter within 18 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Multiple Sclerosis, Chronic Progressive →