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

Primary Purpose

Parkinson Disease, Physical Activity, Gait Disorders, Neurologic

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
HiBalance
Speech and communication therapy
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Balance control, Exercise, Magnetic Resonance Imaging, Functional Magnetic Resonance Imaging

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Karolinska institutet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HiBalance

Speech therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mini-BESTest

Secondary Outcome Measures

Gait parameters
Neuropsychological tests
Quality of life questionnaires
Movement Disorder Society - Unified Parkinsons disease rating scale
Disease severity in Parkinsons disease
Physical activity measured with accelerometers
Structural Magnetic Resonance Imaging
Functional Magnetic Resonance Imaging
Wet biomarkers
BDNF in serum

Full Information

First Posted
July 5, 2017
Last Updated
December 2, 2020
Sponsor
Karolinska Institutet
Collaborators
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03213873
Brief Title
Neuroplasticity in Parkinson´s Disease After Training
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
December 13, 2019 (Actual)
Study Completion Date
December 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Karolinska University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Physical Activity, Gait Disorders, Neurologic, Neural Degeneration
Keywords
Balance control, Exercise, Magnetic Resonance Imaging, Functional Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Investigator and outcome assessors are masked to group allocation at baseline assessment. Care providers are masked to results of the assessments. Participants are masked to the studied intervention/treatment.
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HiBalance
Arm Type
Experimental
Arm Description
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.
Arm Title
Speech therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HiBalance
Intervention Description
Intervention of highly challenging balance training for 10 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Speech and communication therapy
Intervention Description
Intervention conducted by speech and language therapist for 10 weeks.
Primary Outcome Measure Information:
Title
Mini-BESTest
Time Frame
Change in balance performance at 10 weeks.
Secondary Outcome Measure Information:
Title
Gait parameters
Time Frame
Change in gait parameters at 10 weeks
Title
Neuropsychological tests
Time Frame
Change in cognitive functions at 10 weeks
Title
Quality of life questionnaires
Time Frame
Change in quality of life at 10 weeks
Title
Movement Disorder Society - Unified Parkinsons disease rating scale
Description
Disease severity in Parkinsons disease
Time Frame
Change in disease severity at 10 weeks
Title
Physical activity measured with accelerometers
Time Frame
Change in physical activity at 10 weeks
Title
Structural Magnetic Resonance Imaging
Time Frame
Change in structures of the brain at 10 weeks
Title
Functional Magnetic Resonance Imaging
Time Frame
Change in functional connectivity at 10 weeks.
Title
Wet biomarkers
Description
BDNF in serum
Time Frame
Change in wet biomarkers at 10 weeks
Other Pre-specified Outcome Measures:
Title
Dysarthria
Description
SOFT questionnaire
Time Frame
Change in self-rated dysarthria at 10 weeks
Title
Voice strength
Description
Measured by speech and language pathologist using a voice recorder
Time Frame
Change in voice strength at 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Eriksdotter, Professor
Organizational Affiliation
Karolinska Institutet, NVS department
Official's Role
Study Chair
Facility Information:
Facility Name
Karolinska institutet
City
Huddinge
ZIP/Postal Code
14183
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Currently we do not have IRB for sharing.
Citations:
PubMed Identifier
23017069
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.
Results Reference
background
PubMed Identifier
25608520
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.
Results Reference
background
PubMed Identifier
31718583
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.
Results Reference
background
PubMed Identifier
32300475
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.
Results Reference
background
PubMed Identifier
35064138
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.
Results Reference
derived
PubMed Identifier
34369451
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.
Results Reference
derived
PubMed Identifier
33719728
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.
Results Reference
derived

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Neuroplasticity in Parkinson´s Disease After Training

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