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Neuroplasticity in Parkinson´s Disease After Training (BETA-PD)

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ClinicalTrials.gov Identifier: NCT03213873
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : December 27, 2017
Sponsor:
Collaborator:
Karolinska University Hospital
Information provided by (Responsible Party):
Erika Franzén, 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Physical Activity Gait Disorders, Neurologic Neural Degeneration Behavioral: HiBalance Behavioral: Speech and communication therapy Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: Investigator and outcome assessors are masked to group allocation at baseline assessment. Care providers are masked to results of the assessments.
Primary Purpose: Treatment
Official Title: Effects of the HiBalance-program: Linking Clinical Signs and Symptoms to Changes in the Brain in People With Parkinson´s Disease
Actual Study Start Date : August 15, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Behavioral: HiBalance
Intervention of highly challenging balance training for 10 weeks.
Active Comparator: Speech 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.
Behavioral: Speech and communication therapy
Intervention conducted by speech and language therapist for 10 weeks.



Primary Outcome Measures :
  1. Mini-BESTest [ Time Frame: Change in balance performance at 10 weeks. ]

Secondary Outcome Measures :
  1. Gait parameters [ Time Frame: Change in gait parameters at 10 weeks ]
  2. Neuropsychological tests [ Time Frame: Change in cognitive functions at 10 weeks ]
  3. Quality of life questionnaires [ Time Frame: Change in quality of life at 10 weeks ]
  4. Movement Disorder Society - Unified Parkinsons disease rating scale [ Time Frame: Change in disease severity at 10 weeks ]
    Disease severity in Parkinsons disease

  5. Physical activity measured with accelerometers [ Time Frame: Change in physical activity at 10 weeks ]
  6. Structural Magnetic Resonance Imaging [ Time Frame: Change in structures of the brain at 10 weeks ]
  7. Functional Magnetic Resonance Imaging [ Time Frame: Change in functional connectivity at 10 weeks. ]
  8. Wet biomarkers [ Time Frame: Change in wet biomarkers at 10 weeks ]

Other Outcome Measures:
  1. Dysarthria [ Time Frame: Change in self-rated dysarthria at 10 weeks ]
    SOFT questionnaire

  2. Voice strength [ Time Frame: Change in voice strength at 10 weeks ]
    Measured by speech and language pathologist using a voice recorder



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of idiopathic Parkinson´s disease
  • Hoehn & Yahr 2-3

Exclusion Criteria:

  • < 21 points on MoCA
  • Other existing neuromuscular disorder or other disorder that may interfere with gait and balance performance
  • Claustrophobia
  • Metal implants
  • Pacemaker
  • Deep brain stimulators

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03213873


Contacts
Contact: Erika Franzén, PhD +46852488878 erika.franzen@ki.se
Contact: Maria Hagströmer, PhD +46852488836 maria.hagstromer@ki.se

Locations
Sweden
Karolinska institutet Recruiting
Huddinge, Sweden, 14183
Sponsors and Collaborators
Karolinska Institutet
Karolinska University Hospital
Investigators
Study Chair: Maria Eriksdotter, Professor Karolinska Institutet, NVS department

Publications:
Responsible Party: Erika Franzén, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03213873     History of Changes
Other Study ID Numbers: 4-2872/2016
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Currently we do not have IRB for sharing.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Erika Franzén, Karolinska Institutet:
Balance control
Exercise
Magnetic Resonance Imaging
Functional Magnetic Resonance Imaging

Additional relevant MeSH terms:
Gait Disorders, Neurologic
Parkinson Disease
Nervous System Diseases
Nerve Degeneration
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Pathologic Processes