The EXPANd trial: effects of exercise and exploring neuroplastic changes in people with Parkinson’s disease: a study protocol for a double-blinded randomized controlled trial

Abstract

BackgroundParkinson’s disease (PD) affects many physiological systems essential for balance control. Recent studies suggest that intensive and cognitively demanding physical exercise programs are capable of inducing plastic brain changes in PD. We have developed a highly challenging balance training (the HiBalance) program that emphasizes critical aspects of balance control through progressively introducing more challenging exercises which incorporates dual-tasking. Earlier studies have shown it to be effective in improving balance, gait and dual-tasking. The study design has thereafter been adjusted to link intervention-induced behavioral changes to brain morphology and function. Specifically, in this randomized controlled trial, we will determine the effects of the HiBalance program on balance, gait and cognition and relate this to task-evoked functional MRI (fMRI), as well as brain-derived neurotrophic factor (BDNF) in participants with mild-moderate PD.MethodsOne hundred participants with idiopathic PD, Hoehn & Yahr stage 2 or 3, ≥ 60 years of age, ≥ 21 on Montreal Cognitive Assessment will be recruited in successive waves and randomized into either the HiBalance program or to an active control group (the HiCommunication program, targeting speech and communication). Both interventions will be performed in small groups, twice a week with 1 h sessions for 10 weeks. In addition, a 1 h, once a week, home exercise program will also be performed. A double-blinded design will be used. At the pre- and post-assessments, participants will be assessed on balance (main outcome), gait, cognitive functions, physical activity, voice/speech function, BDNF in serum and fMRI (3 T Philips) during performance of motor-cognitive tasks.DiscussionSince there is currently no cure for PD, findings of neuroplastic brain changes in response to exercise would revolutionize the way we treat PD, and, in turn, provide new hope to patients for a life with better health, greater independence and improved quality of life.Trial registrationClincalTrials.gov: NCT03213873, first posted July 11, 2017.

Dual-Task Effects During a Motor-Cognitive Task in Parkinson’s Disease: Patterns of Prioritization and the Influence of Cognitive Status

“…This study used a cross-sectional design based on baseline data from the EXercise in Parkinson’s disease and Neuroplasticity Trial (EXPANd; registered at clinicaltrials.gov NCT03213873). 17 Data collection commenced in January 2018 and concluded in August 2019. Assessments were performed in a university setting.…”

Measuring implicit sequence learning and dual task ability in mild to moderate Parkinson´s disease: A feasibility study

“…After each block, the participants had six seconds to respond to how many plus signs they had seen by choosing between four alternatives (ranging from 0 to 7 integers from the correct alternative). This non-verbal multiple-choice question was used instead of a free recall to minimize the risk of movement when the task is to be performed in the MRI scanner in our upcoming trial [ 17 ]. The participants were instructed to focus on both tasks to an equal extent.…”

“…A large randomized controlled trial (RCT) by our research group showed that a highly challenging balance training positively affected gait and balance as well as the dual task performance of a cognitive task (performed while walking) in individuals with mild to moderate PD [ 15 , 16 ]. We are now planning a similar trial with the addition of brain activity assessments as measured by functional magnetic resonance imaging (fMRI), see our study protocol [ 17 ]. During fMRI, we plan to use a version of the SRTT as a measure of implicit sequence learning ability and to use a similar choice reaction time task with the addition of a simple counting task (from here on referred to as the dual task), as a measure of dual task ability.…”

Exercise for Older Adults Improves the Quality of Life in Parkinson’s Disease and Potentially Enhances the Immune Response to COVID-19

“…A few obstacles include which biological markers are the most useful for measuring neuroplasticity and what imaging techniques/tools would be most helpful to document changes in the neural networks [107]. A clinical trial [108] and a feasibility study [109] for exercise-induced neuroplasticity in PD are currently underway.…”