Karolinska institutet
Huddinge, 14183, Sweden
NCT Number: NCT03213873
This project aims to determine the effects of the HiBalance program on neuroplastic changes in people with mild to moderate Parkinson´s disease. The main hypothesis is that highly challenging exercise will lead to greater gait and balance ability, increased levels of physical activity and an improved health related quality of life. The investigators further hypothesize that neuroplasticity changes will be seen in corresponding areas of the brain, neuropsychological changes on cognitive test measures, and that exercise will inhibit the degeneration of dopaminergic neurons in the brain through the mediation of neurotrophic factors.
Looking for future studies?
Notify Me60 year and older
All sexes
Interventional
Not applicable
Huddinge, 14183, Sweden
Parkinson's disease (PD) is a neurodegenerative disease affecting many physiological systems essential for balance control. New findings suggest that intensive, challenging and cognitively demanding exercises could induce neuroplasticity in PD. A new balance training (the HiBalance program) have therefore been developed; emphasizing critical aspects of balance control through highly challenging and progressive exercises incorporating dual/multi-tasking (Conradsson et al, 2012). In an RCT, the HiBalance-program was shown to improve balance, gait and physical activity level in favor for the training group (Conradsson et al, 2015). In this proposal the investigators will combine physiotherapy, neurology and neuroimaging to characterise and determine the effects on physical and cognitive symptoms as well as structural and functional changes and wet biomarkers in the brain after the training.
Participants will be recruited through Karolinska University Hospital and via announcements in relevant forums like for instance the Swedish Parkinson Association. According to earlier power calculations for detecting effects in balance and gait measures after this particular intervention, the investigators anticipate 40 to 50 participants in each group to detect significant changes.
The investigators will perform both per protocol analysis and intention to treat analysis using mixed model or repeated measurement ANOVAs if the data is normally distributed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Additional exclusion criteria for the brain imaging will include the presence of; pacemakers, deep brain stimulators or other MRI incompatible implants, claustrophobia, inability to hear instructions without hearing aid, unilateral or bilateral blindness, severe diplopia, tremor, dyskinesia or dystonia.
Intervention of highly challenging balance training for 10 weeks.
Intervention conducted by speech and language therapist for 10 weeks.
Time frame: Pre intervention baseline and post intervention at 10 weeks
Mini-Balance Evaluation Systems Test a rating scale for dynamic balance incorporating 14 different balance and gait items that were assessed by a physical therapist on a scale from 0-2. Maximum points 28.
0-28 points with higher scores indicating better balance control
Time frame: Pre intervention baseline and post intervention at 10 weeks
Gait speed in m/sec
Time frame: Pre intervention baseline and post intervention at 10 weeks
Composite measure of executive functions of four tests:
First, the scores of each of the four tests were standardised into z-scores using pre-scores. Models using different test were compared. The model including all four tests and using the robust diagonally weighted least square estimation was chosen based on fit values. Factor loadings of the model: verbal fluency = 1.000, the verbal fluency test: category switching= 0.887, the colour-word interference test: switch condition= -0.855, the digit span total score= 0.813. Last, the z-scores of each test and person were multiplied with the factor loadings and added together to create a sum score for each person and time point. A higher value = greater executive functions
Time frame: Pre intervention baseline and post intervention at 10 weeks
The Parkinson's Disease Questionnaire (PDQ-39) assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living (mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communications and bodily discomfort).
The sum score is as a percentage score ranging between 0 and 100. Higher is better
Time frame: Pre intervention baseline and post intervention at 10 weeks
Disease severity/symtoms in Parkinson's disease, Movement Disorder Society - Unified Parkinsons disease rating scale (MDS-UPDRS) Total score.
Higher score is worse, ranging from 0-272
Time frame: Pre intervention baseline and post intervention at 10 weeks
Number of Steps per day.
Time frame: Pre intervention baseline and post intervention at 10 weeks
Intervention dependent changes in brain structure i.e. gray matter volume measured as voxels Analyses defined as: were there any significant clusters of voxels explained by the interaction of group and time. In other words, were there significant changes in voxel activity that depended on the interventions when using a cluster-based threshold using group statistics..
Note that it is not possible to report this outcome per group. Additionally, MR statistics are not reported as measures of central tendency such as the mean or any alternatives provided.
Time frame: Pre intervention baseline and post intervention at 10 weeks
Intervention dependent changes in task-induced brain activity, voxel-wise analyses of whole brain. (Name of the task performed during fMRI; the serial reaction time task.)
Analyses defined as: were there any significant clusters of voxels explained by the interaction of group and time. In other words, were there significant changes in voxel activity that depended on the interventions when using a cluster-based threshold. The measure type number was chosen because we estimated the number of significant clusters of voxels. Group statistics were perfromed
Note that for task fMRI interaction analyses, there are no meaningful values to report for the groups respectively.
Time frame: Pre intervention baseline and post intervention at 10 weeks
Mature Brain-derived neurotrophic factor (mBDNF) in serum
Time frame: Pre intervention baseline
The Dysarthria Assessment also includes the Questionnaire on Acquired Speech Disorders (QASD, Swedish: Självsvarsformulär om Förvärvade Talstörningar) which is a self-report instrument that captures the subjective symptoms and experiences of individuals living with acquired speech disorders. Three subscales are included: "My Speech and Language", "Speech and Language in Social Interaction", and "Personal and Environmental Factors". Each item is rated on a four-point scale from 0 (definitely false) to 3 (definitely true), with higher scores indicating more severe symptoms. The overall QASD score was determined by calculating the average score of all sub-scales.
Time frame: Pre intervention baseline and post intervention at 10 weeks
The recordings were performed according to standardised routines for high-quality recordings in a sound-proof recording studio with the equipment Sony Digital Audio Tape Deck DTC-ZE700 and the software Sopran (version 1.0.22 © Tolvan Data). Measures were performed by a speech and language pathologist.
The outcome measure from the studio recordings used in the present study was mean voice sound level (dB SPL) in reading a Swedish standardised text.
Karolinska Institutet
Other
Effects of the HiBalance-program: Linking Clinical Signs and Symptoms to Changes in the Brain in People With Parkinson´s Disease
Acronym: BETA-PD
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