Effects of a Remote Multimodal Intervention Involving Diet, Walking Program, and Breathing Exercise on Quality of Life Among Newly Diagnosed People with Multiple Sclerosis: A Quasi-Experimental Non-Inferiority Pilot Study

Abstract

Background

Interventions involving diet, physical activity, and breathing exercises are shown to be beneficial in managing both fatigue and quality of life (QoL) related to MS; however, the impact of such interventions among people newly diagnosed with clinically isolated syndrome (CIS) or relapsing-remitting multiple sclerosis (RRMS) who decline disease-modifying therapies (DMTs) is unknown.

Methods

A 12-month prospective quasi-experimental non-inferiority trial recruited people newly diagnosed with CIS or RRMS who voluntarily declined DMTs (health behavior group; HB, n = 29) or followed standard of care (SOC, n = 15). Participants in the HB group were remotely coached on the study diet, moderate-intensity walking, and breathing exercises. All participants completed questionnaires validated to assess MS symptoms, including perceived mental and physical QoL (MSQOL54); fatigue (Fatigue Severity Scale, FSS; and Modified Fatigue Impact Scale, MFIS); mood (Hospital Anxiety and Depression Scale, HADS); and cognitive function (Perceived Deficits Questionnaire, PDQ).

Results

During the 12 months, the HB group experienced improvement in scores for mental QoL (MSQOL54 – Mental, 0.24, 95% CI 0.01, 0.47; p = 0.04), fatigue (Total MFIS, −7.26, 95% CI −13.3,-1.18; p = 0.02), and perceived cognitive function (Total PDQ, PDQ–Attention, PDQ–Promemory, and PDQ–Planning, p ≤ 0.03 for all). A between-group difference was observed only for PDQ–Planning (p = 0.048). Non-inferiority analysis revealed that the 12-month changes in means for the HB group were not worse than those for the SOC group with respect to fatigue (FSS, p = 0.02), mood (HDS–Anxiety, p = 0.02; HADS–Depression, p < 0.0001), physical QoL (MSQOL54 – Physical, p = 0.02), or cognitive dysfunction (Total PDQ, p = 0.01).

Conclusion

The multimodal lifestyle intervention for individuals newly diagnosed with CIS or RRMS, who voluntarily decline DMTs, did not yield patient-reported outcomes worse than those observed in the SOC group regarding perceived mental quality of life, mood, fatigue, and cognitive function.

Trial Registration

clinicaltrials.gov identifier: NCT04009005.

Keywords:

• multiple sclerosis
• modified paleolithic diet
• physical activity
• mindfulness-based breathing
• quasi-experimental

Data Sharing Statement

The data presented in this study are available on request from the corresponding author. The data are not publicly available due to containing information that could compromise the privacy of research participants.

Acknowledgments

The authors want to acknowledge the University of Iowa students who supported recruitment and data acquisition, Christine Blaumueller for her editing assistance, and thank the study participants for their dedication and commitment to the study intervention.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Conflict of Interest Disclosures: Dr Terry Wahls personally follows and promotes the Wahls™ diet. She has equity interest in the following companies: Terry Wahls LLC; TZ Press LLC; The Wahls Institute, PLC; FBB Biomed Inc.; Levels Health Inc., and the website http://www.terrywahls.com. She also owns the copyright to the books Minding My Mitochondria (2nd Edition) and The Wahls Protocol, The Wahls Protocol Cooking for Life, and the trademarks The Wahls Protocol^® and Wahls™ diet, Wahls Paleo™ diet, and Wahls Paleo Plus™ diets. She has completed grant funding from the National Multiple Sclerosis Society for the Dietary Approaches to Treating Multiple Sclerosis Related Fatigue Study. She has financial relationships with Vibrant America LLC, Standard Process Inc., MasterHealth Technologies Inc., Foogal Inc., and the Institute for Functional Medicine Inc. She receives royalty payments from Penguin Random House. Dr Wahls has conflict-of-interest management plans in place with the University of Iowa and the Iowa City Veteran’s Affairs Medical Center. This study received funding from Dr Terry Wahls LLC. The funder had the following involvement with the study: study design, the writing of this article, and the decision to submit it for publication. Also, Dr Tyler Titcomb received Fellowship fund that supported me for this study from the Carter Chapman Shreve Family Foundation, during the conduct of the study.

All authors declare no other competing interests.

Additional information

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: SMS is a research trainee of the University of Iowa Fraternal Order of Eagles Diabetes Research Center (T32DK112751-06). TJT, SMS, and FS were supported by the Carter Chapman Shreve Family Foundation and the Carter Chapman Shreve Fellowship Fund for diet and lifestyle research conducted by the Wahls Research team at the University of Iowa. In-kind support was provided by the University of Iowa College of Public Health Preventive Intervention Center and Dr Terry Wahls LLC. The trial was supported by the Institute for Clinical and Translational Science (ICTS) at the University of Iowa, and University of Iowa institutional funds. The ICTS is supported by the National Institutes of Health Clinical and Translational Science Award program (UM1TR004403).