Neuroplasticity in Parkinson´s Disease After Training

NCT03213873 | Completed Results

• 1 other identifier: 4-2872/2016
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Physical Activity; Gait Disorders, Neurologic; Neural Degeneration

Keywords

Balance control; Exercise; Magnetic Resonance Imaging; Functional Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Mini-BESTest

  Mini-Balance Evaluation Systems Test a rating scale for dynamic balance incorporating 14 different balance and gait items that were assessed by a physical therapist on a scale from 0-2. Maximum points 28. 0-28 points with higher scores indicating better balance control

  Pre intervention baseline and post intervention at 10 weeks

Secondary Outcomes (8)

• Gait Parameters

  Pre intervention baseline and post intervention at 10 weeks

• Neuropsychological Tests

  Pre intervention baseline and post intervention at 10 weeks

• Quality of Life Questionnaires

  Pre intervention baseline and post intervention at 10 weeks

• Movement Disorder Society - Unified Parkinsons Disease Rating Scale (MDS-UPDRS)

  Pre intervention baseline and post intervention at 10 weeks

• Physical Activity Measured With Accelerometers

  Pre intervention baseline and post intervention at 10 weeks

Other Outcomes (2)

• Dysarthria

  Pre intervention baseline

• Voice Strength

  Pre intervention baseline and post intervention at 10 weeks

Study Arms (2)

HiBalance

EXPERIMENTAL

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

Speech therapy

ACTIVE COMPARATOR

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

Interventions

HiBalance BEHAVIORAL

Intervention of highly challenging balance training for 10 weeks.

HiBalance

Speech and communication therapy BEHAVIORAL

Intervention conducted by speech and language therapist for 10 weeks.

Speech therapy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of idiopathic Parkinson´s disease
• Hoehn \& Yahr 2-3
• ≥ 60 years of age
• Be able to ambulate indoors without mobility aid
• Balance impairment

You may not qualify if:

• =\< 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska institutet

Huddinge, 14183, Sweden

Location

Related Publications (10)

• 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.

  PMID: 23017069 BACKGROUND

• 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.

  PMID: 25608520 BACKGROUND

• 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.

  PMID: 31718583 BACKGROUND

• 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.

  PMID: 32300475 BACKGROUND

• Steurer H, Gustafsson JK, Franzen E, Schalling E. Auditory-Perceptual Analysis of Speech Outcomes Following HiCommunication Intervention in Parkinson's Disease-A Secondary Analysis of a Randomized Controlled Trial. J Voice. 2025 Jul 8:S0892-1997(25)00234-6. doi: 10.1016/j.jvoice.2025.06.015. Online ahead of print.

  PMID: 40628546 DERIVED

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  PMID: 38588457 DERIVED

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

  PMID: 36602886 DERIVED

• 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.

  PMID: 35064138 DERIVED

• 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.

  PMID: 34369451 DERIVED

• 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.

  PMID: 33719728 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Motor Activity; Gait Disorders, Neurologic; Nerve Degeneration

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Results Point of Contact

• Title: Erika Franzén
• Organization: Karolinska Institutet

erika.franzen@ki.se

08-52488878

Study Officials

• Maria Eriksdotter, Professor

  Karolinska Institutet, NVS department

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 11, 2017
• Study Start: August 15, 2017
• Primary Completion: December 13, 2019
• Study Completion: December 23, 2019
• Last Updated: March 7, 2025
• Results First Posted: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)