NCT03213873

Neuroplasticity in Parkinson´s Disease After Training

Effects of the HiBalance-program: Linking Clinical Signs and Symptoms to Changes in the Brain in People With Parkinson´s Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson Disease
• Physical Activity
• Gait Disorders, Neurologic
• Neural Degeneration

Interventions

Type	Name	Description
BEHAVIORAL	HiBalance	Intervention of highly challenging balance training for 10 weeks.
BEHAVIORAL	Speech and communication therapy	Intervention conducted by speech and language therapist for 10 weeks.

Timeline

• Start date: 2017-08-15
• Primary completion: 2019-12-13
• Completion: 2019-12-23
• First posted: 2017-07-11
• Last updated: 2025-03-07
• Results posted: 2025-03-07

Locations

1 site across 1 country: Sweden