Effects of the HiBalance-program: Linking Clinical Signs and Symptoms to Changes in the Brain in People With Parkinson´s Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Karolinska Institutet
- Enrollment
- 95
- Locations
- 1
- Primary Endpoint
- Mini-BESTest
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Erika Franzén
Associate Professor
Karolinska Institutet
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of idiopathic Parkinson´s disease
- •Hoehn \& Yahr 2-3
- •≥ 60 years of age
- •Be able to ambulate indoors without mobility aid
- •Balance impairment
Exclusion Criteria
- •=\< 21 points on MoCA
- •Other medical conditions that could substantially influence balance performance, voice or speech performance or participation in the interventions
- •Participating in an intensive exercise program for balance or speech during the last six months.
- •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.
Outcomes
Primary Outcomes
Mini-BESTest
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
Secondary Outcomes
- Gait Parameters(Pre intervention baseline and post intervention at 10 weeks)
- Neuropsychological Tests(Pre intervention baseline and post intervention at 10 weeks)
- Quality of Life Questionnaires(Pre intervention baseline and post intervention at 10 weeks)
- Movement Disorder Society - Unified Parkinsons Disease Rating Scale (MDS-UPDRS)(Pre intervention baseline and post intervention at 10 weeks)
- Physical Activity Measured With Accelerometers(Pre intervention baseline and post intervention at 10 weeks)
- Structural Magnetic Resonance Imaging(Pre intervention baseline and post intervention at 10 weeks)
- Task-induced Brain Activity as Measured by Functional Magnetic Resonance Imaging(Pre intervention baseline and post intervention at 10 weeks)
- Wet Biomarkers(Pre intervention baseline and post intervention at 10 weeks)