Neuroplasticity in Parkinson´s Disease After Training

Parkinson Disease Clinical Trial

— BETA-PD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03213873
• Other study ID #: 4-2872/2016
• Status: Completed
• Phase: N/A
• Start date: August 15, 2017
• Est. completion date: December 23, 2019

Study information

• Verified date: December 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 23, 2019
• Est. primary completion date: December 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Nerve Degeneration
• Nervous System Diseases
• Neural Degeneration
• Parkinson Disease
• Physical Activity

Intervention

Behavioral:
• HiBalance
Intervention of highly challenging balance training for 10 weeks.
• Speech and communication therapy
Intervention conducted by speech and language therapist for 10 weeks.

Locations

Country	Name	City	State
Sweden	Karolinska institutet	Huddinge

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

Conradsson D, Löfgren N, Nero H, Hagströmer M, Ståhle A, Lökk J, Franzén 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. — View Citation

Conradsson D, Löfgren N, Ståhle A, Hagströmer M, Franzén 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. — View Citation

Franzén E, Johansson H, Freidle M, Ekman U, Wallén MB, Schalling E, Lebedev A, Lövdén M, Holmin S, Svenningsson P, Hagströmer 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. — View Citation

Johansson H, Freidle M, Ekman U, Schalling E, Leavy B, Svenningsson P, Hagströmer M, Franzén 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dysarthria	SOFT questionnaire	Change in self-rated dysarthria at 10 weeks
Other	Voice strength	Measured by speech and language pathologist using a voice recorder	Change in voice strength at 10 weeks
Primary	Mini-BESTest		Change in balance performance at 10 weeks.
Secondary	Gait parameters		Change in gait parameters at 10 weeks
Secondary	Neuropsychological tests		Change in cognitive functions at 10 weeks
Secondary	Quality of life questionnaires		Change in quality of life at 10 weeks
Secondary	Movement Disorder Society - Unified Parkinsons disease rating scale	Disease severity in Parkinsons disease	Change in disease severity at 10 weeks
Secondary	Physical activity measured with accelerometers		Change in physical activity at 10 weeks
Secondary	Structural Magnetic Resonance Imaging		Change in structures of the brain at 10 weeks
Secondary	Functional Magnetic Resonance Imaging		Change in functional connectivity at 10 weeks.
Secondary	Wet biomarkers	BDNF in serum	Change in wet biomarkers at 10 weeks