Neuroplasticity in Parkinson´s Disease After Training

Not Applicable

Completed

• Conditions: Parkinson Disease; Physical Activity; Gait Disorders, Neurologic; Neural Degeneration
• Interventions: Behavioral: HiBalance; Behavioral: Speech and communication therapy

• Registration Number: NCT03213873
• Lead Sponsor: Karolinska Institutet

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-07-05
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-11
• Study Start: 2017-08-15
• Primary Completion: 2019-12-13
• Study Completion: 2019-12-23
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-02
• Last Update Posted: 2020-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HiBalance	HiBalance	The HiBalance program is based on scientifically well-established principles of exercise training and postural control as well as current research on training in PD. The training will be conducted as a progressive individually adjusted group program in order to challenge the specific balance disorder of every participant and endorse progression. The intervention will be performed for an hour, 2 times/week in groups of six to eight participants for a total of 10 weeks and one home training session on their own.
Speech therapy	Speech and communication therapy	The control group will receive a group treatment (2 times/w for 10 w + 1 home training session) consisting of speech and communication therapy performed by a speech therapist. This intervention will be performed in a sitting position. The speech and communication treatment will aim at increasing vocal loudness and improving articulatory precision. Level of difficulty is gradually increased by progressing from using loud voice and clear speech in short and automatized utterances, to using the same technique in more complex sentences and situations. The group format is used to practice techniques in communicative situations and also to introduce increasing level of multitasking by combining speech training with cognitively more challenging tasks in the group training.

Primary Outcome Measures

Name	Time	Method
Mini-BESTest	Change in balance performance at 10 weeks.

Secondary Outcome Measures

Name	Time	Method
Movement Disorder Society - Unified Parkinsons disease rating scale	Change in disease severity at 10 weeks	Disease severity in Parkinsons disease
Gait parameters	Change in gait parameters at 10 weeks
Neuropsychological tests	Change in cognitive functions at 10 weeks
Structural Magnetic Resonance Imaging	Change in structures of the brain at 10 weeks
Wet biomarkers	Change in wet biomarkers at 10 weeks	BDNF in serum
Physical activity measured with accelerometers	Change in physical activity at 10 weeks
Functional Magnetic Resonance Imaging	Change in functional connectivity at 10 weeks.
Quality of life questionnaires	Change in quality of life at 10 weeks

Trial Locations

Locations (1)

Karolinska institutet; 🇸🇪 Huddinge, Sweden