Objective: The aim of this phase II controlled trial is to evaluate the safety, feasibility, and to explore the effects of a multimodal intervention in people with Parkinson’s disease (PwP) as well as associated mechanisms. The comprehensive assessment will focus on 8 key areas of health: cognition, inflammation, microbiome diversity, sleep quality, neurological imaging markers, physical fitness, cardiovascular health, and social and mental well-being.

Background: Despite its rapidly rising prevalence and status as the second most common neurodegenerative disease worldwide, Parkinson’s disease (PD) remains without pharmacological or neuroprotective therapies to prevent or slow down disease progression [1]. Current research suggests that exercise, mindfulness, and nutrition are beneficial for brain health [2,3,4] and that combined interventions are more effective than isolated ones [5]; the goal of this study is thus to evaluate a combined intervention of exercise, mindfulness, and nutrition in PwP.

Method: This study investigates a 6-month intervention consisting of exercise (3h/week), mindfulness (1.5h/week), and MiND-diet based nutrition (1.5h biweekly) classes, held virtually. 60 PwP (H:Y 1-2) are currently being recruited from a large tertiary centre in Vancouver, British Columbia and randomized into either a 6-month waitlist or intervention group, where participants in the waitlist group will receive the intervention after the waitlist period. Various outcome measures are assessed including adherence, adverse events, cognitive function, motor function, inflammation and biomarkers in serum (hs-CRP, calprotectin, cortisol), gut microbiome diversity, sleep quality, MRI measures (anatomical and functional), physical health (cardiorespiratory fitness, balance and gait, body composition), and social and emotional well-being. Data will be compared with 60 healthy controls.

Results: This study is in progress, with 22 enrolled participants, and has a target enrolment completion date of May 2026.

Conclusion: There is considerable interest in multimodal, lifestyle-based interventions for individuals with PD. This study will be vital in understanding the feasibility and explore the associated mechanisms of change in PD. The results will also inform the design of a larger phase III trial investigating the efficacy of these interventions.

References: 1. Bloem BR, Okun MS, Klein C. Parkinson’s disease. The Lancet. 2021;397(10291):2284-2303. doi:10.1016/S0140-6736(21)00218-X

2. Bray NW, Pieruccini-Faria F, Bartha R, Doherty TJ, Nagamatsu LS, Montero-Odasso M. The effect of physical exercise on functional brain network connectivity in older adults with and without cognitive impairment. A systematic review. Mech Ageing Dev. 2021;196:111493. doi:10.1016/j.mad.2021.111493

3. Marx W, Moseley G, Berk M, Jacka F. Nutritional psychiatry: the present state of the evidence. Proc Nutr Soc. 2017;76(4):427-436. doi:10.1017/S0029665117002026

4. Pernet CR, Belov N, Delorme A, Zammit A. Mindfulness related changes in grey matter: a systematic review and meta‐analysis. Brain Imaging Behav. 2021;15(5):2720-2730. doi:10.1007/s11682-021-00453-4

5. Alderman BL, Olson RL, Brush CJ, Shors TJ. MAP training: combining meditation and aerobic exercise reduces depression and rumination while enhancing synchronized brain activity. Transl Psychiatry. 2016;6(2):e726. doi:10.1038/tp.2015.225

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MDS Abstracts - https://www.mdsabstracts.org/abstract/impact-360-study-for-parkinsons-disease-a-controlled-phase-ii-feasibility-and-safety-study-of-a-combined-exercise-diet-and-mindfulness-intervention/