Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07443293
Brief Summary:
The IMPACT 360 study will evaluate the effects of a combined intervention of exercise, mindfulness, and nutrition on 8 key indicators of health and the mechanisms that drive these changes. 60 subjects aged 40 to 85 with a current diagnosis Parkinson's disease will be recruited. This study will follow a partial crossover design. All participants will receive the intervention. Participants randomized into the intervention group after their baseline screening will receive the 6-month intervention. Those randomized into the waitlist group will complete another assessment at the end of the 6-month care as usual phase before receiving the intervention.
Detailed Description:
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. While there is marked heterogeneity in its presentation, PD is diagnostically linked to motor impairments, including bradykinesia (slowness of movement), tremors, rigidity, dyskinesia (involuntary, erratic movement), and dystonia (involuntary muscle contraction causing slow, repetitive movement), as well as cognitive decline and neuroinflammation, negatively affecting activities of daily living. Additionally, PD may have a very long prodromal phase, which can last up to decades. During this period, individuals may develop non-motor symptoms, including REM-Sleep Behaviour Disorder (RBD), a nervous system disorder. Typically, during REM sleep, individuals experience a loss of muscle tone, which is absent from those with RBD. As such, RBD is generally characterized by a tendency to act out dreams. Due to the very high specificity for people with RBD to later develop PD26, the study of individuals with idiopathic RBD is particularly valuable, as pathology to the brain is limited at this time. Information about the early, premotor stages of PD can be gathered at a time when therapeutic interventions are most promising. Current research suggests that exercise, meditation, and nutrition have beneficial neuroprotective effects. Physical activity has been associated with improved learning and memory and cognitive function. Long-term exercise has also been shown to upregulate anti-inflammatory and neuroprotective factors. Research examining the effects of mindfulness interventions have found significant increases in grey matter and functional connectivity. Diets high in fruit and vegetable content and low in higher-inflammatory foods such as red meats and sweets, like the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet, have been shown to increase levels of plasma brain-derived neurotrophic factor. The benefits of these individual interventions have been shown, but emerging evidence suggests that combined interventions are more powerful than isolated ones. The crucial next step is to study the impact of a multimodal program on brain health and to comprehensively examine underlying mechanisms.
Risk factors for many neurological conditions can be modified, indicating that some instances of neurological dysfunction can be prevented through lifestyle modifications. For example, potentially modifiable risk factors for dementia include: high blood pressure, Type 2 diabetes, obesity, lack of physical activity, hearing loss, and poor diet. Many of these can be improved through exercise and nutrition and there is evidence that this combined lifestyle intervention may also be beneficial for those already diagnosed with neurological conditions. A comprehensive examination evaluating health and wellness in people with Parkinson's disease (PwP) and people with RBD (PwRBD) will help us to understand the mechanisms behind the benefits of this combined intervention and how the interactive effects impact one's overall health.
The aim of this study is to evaluate the effects of a multimodal intervention in PwP and PwRBD and to elucidate the mechanisms driving the associated changes. The comprehensive assessment ("360 degree approach") 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. Glucose metabolism will be evaluated as an optional 9th key area of health.
Study:
NCT07443293
Study Brief:
Protocol Section:
NCT07443293