Clinical trial NCT03213873: Neuroplasticity in Parkinson´s Disease After Training
Official title: Effects of the HiBalance-program: Linking Clinical Signs and Symptoms to Changes in the Brain in People With Parkinson´s Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Physical Activity
Gait Disorders, Neurologic
Neural Degeneration
Keywords: Balance control
Exercise
Magnetic Resonance Imaging
Functional Magnetic Resonance Imaging
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2017-07-11
Enrollment: 95
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mini-BESTest
timeFrame: Pre intervention baseline and post intervention at 10 weeks
Secondary outcomes:
measure: Gait Parameters
timeFrame: Pre intervention baseline and post intervention at 10 weeks
measure: Neuropsychological Tests
timeFrame: Pre intervention baseline and post intervention at 10 weeks
measure: Quality of Life Questionnaires
timeFrame: Pre intervention baseline and post intervention at 10 weeks
measure: Movement Disorder Society - Unified Parkinsons Disease Rating Scale (MDS-UPDRS)
timeFrame: Pre intervention baseline and post intervention at 10 weeks
measure: Physical Activity Measured With Accelerometers
timeFrame: Pre intervention baseline and post intervention at 10 weeks
measure: Structural Magnetic Resonance Imaging
timeFrame: Pre intervention baseline and post intervention at 10 weeks
measure: Task-induced Brain Activity as Measured by Functional Magnetic Resonance Imaging
timeFrame: Pre intervention baseline and post intervention at 10 weeks
measure: Wet Biomarkers
timeFrame: Pre intervention baseline and post intervention at 10 weeks
Other outcomes:
measure: Dysarthria
timeFrame: Pre intervention baseline
measure: Voice Strength
timeFrame: Pre intervention baseline and post intervention at 10 weeks
Locations:
city: Huddinge
country: Sweden
facility: Karolinska institutet
Study officials:
affiliation: Karolinska Institutet, NVS department
name: Maria Eriksdotter, Professor
role: STUDY_CHAIR
References:
citation: Conradsson D, Lofgren N, Stahle A, Hagstromer M, Franzen E. A novel conceptual framework for balance training in Parkinson's disease-study protocol for a randomised controlled trial. BMC Neurol. 2012 Sep 27;12:111. doi: 10.1186/1471-2377-12-111.
citation: Conradsson D, Lofgren N, Nero H, Hagstromer M, Stahle A, Lokk J, Franzen E. The Effects of Highly Challenging Balance Training in Elderly With Parkinson's Disease: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2015 Oct;29(9):827-36. doi: 10.1177/1545968314567150. Epub 2015 Jan 21.
citation: Franzen E, Johansson H, Freidle M, Ekman U, Wallen MB, Schalling E, Lebedev A, Lovden M, Holmin S, Svenningsson P, Hagstromer M. 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. BMC Neurol. 2019 Nov 12;19(1):280. doi: 10.1186/s12883-019-1520-2.
citation: Johansson H, Freidle M, Ekman U, Schalling E, Leavy B, Svenningsson P, Hagstromer M, Franzen E. Feasibility Aspects of Exploring Exercise-Induced Neuroplasticity in Parkinson's Disease: A Pilot Randomized Controlled Trial. Parkinsons Dis. 2020 Mar 25;2020:2410863. doi: 10.1155/2020/2410863. eCollection 2020.
citation: Freidle M, Johansson H, Ekman U, Lebedev AV, Schalling E, Thompson WH, Svenningsson P, Lovden M, Abney A, Albrecht F, Steurer H, Leavy B, Holmin S, Hagstromer M, Franzen E. Behavioural and neuroplastic effects of a double-blind randomised controlled balance exercise trial in people with Parkinson's disease. NPJ Parkinsons Dis. 2022 Jan 21;8(1):12. doi: 10.1038/s41531-021-00269-5.
citation: Leavy B, Hagstromer M, Conradsson DM, Franzen E. Physical Activity and Perceived Health in People With Parkinson Disease During the First Wave of Covid-19 Pandemic: A Cross-sectional Study From Sweden. J Neurol Phys Ther. 2021 Oct 1;45(4):266-272. doi: 10.1097/NPT.0000000000000372.
citation: Johansson H, Ekman U, Rennie L, Peterson DS, Leavy B, Franzen E. Dual-Task Effects During a Motor-Cognitive Task in Parkinson's Disease: Patterns of Prioritization and the Influence of Cognitive Status. Neurorehabil Neural Repair. 2021 Apr;35(4):356-366. doi: 10.1177/1545968321999053. Epub 2021 Mar 10.