Parkinson DiseaseBETA-PDNCT03213873
Neuroplasticity in Parkinson´s Disease After Training
A study testing HiBalance and Speech and communication therapy in people with Parkinson Disease and Physical Activity, run by Karolinska Institutet at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Parkinson Disease, Physical Activity, Gait Disorders, Neurologic
- What is being tested?
- HiBalance and Speech and communication therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteSweden
- Study dates
- 15 Aug 2017to 23 Dec 2019
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic Parkinson´s disease
- Hoehn \& Yahr 2-3
- ≥ 60 years of age
- Be able to ambulate indoors without mobility aid
- Balance impairment
Who cannot join
- =< 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the HiBalance-program: Linking Clinical Signs and Symptoms to Changes in the Brain in People With Parkinson´s Disease
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.
Read the 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.
- Being tested
- HiBalance, Speech and communication therapy
- Keywords
- Balance control, Exercise, Magnetic Resonance Imaging, Functional Magnetic Resonance Imaging
- Medical subject headings
- Parkinson Disease, Motor Activity, Gait Disorders, Neurologic, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HiBalanceBehavioural
Intervention of highly challenging balance training for 10 weeks.
Speech and communication therapyBehavioural
Intervention conducted by speech and language therapist for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Speech and communication therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Pre intervention baseline and post intervention at 10 weeks
Secondary outcomes (8)
Gait Parameters
Gait speed in m/sec
Measured: Pre intervention baseline and post intervention at 10 weeks
Neuropsychological Tests
Composite measure of executive functions of four tests:
- letter fluency
- the verbal fluency test: category switching
- the colour-word interference test: switch condition (Test 1, 2 and 3 from the Delis-Kaplan Executive Function System)
- the digit span total score (from Wechsler Adult Intelligence Scale)
First, the scores of each of the four tests were standardised into z-scores using pre-scores. Models using different test were compared. The model including all four tests and using the robust diagonally weighted least square estimation was chosen based on fit values. Factor loadings of the model: verbal fluency = 1.000, the verbal fluency test: category switching= 0.887, the colour-word interference test: switch condition= -0.855, the digit span total score= 0.813. Last, the z-scores of each test and person were multiplied with the factor loadings and added together to create a sum score for each person and time point. A higher value = greater executive functions
Measured: Pre intervention baseline and post intervention at 10 weeks
Quality of Life Questionnaires
The Parkinson's Disease Questionnaire (PDQ-39) assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living (mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communications and bodily discomfort).
The sum score is as a percentage score ranging between 0 and 100. Higher is better
Measured: Pre intervention baseline and post intervention at 10 weeks
Movement Disorder Society - Unified Parkinsons Disease Rating Scale (MDS-UPDRS)
Disease severity/symtoms in Parkinson's disease, Movement Disorder Society - Unified Parkinsons disease rating scale (MDS-UPDRS) Total score.
Higher score is worse, ranging from 0-272
Measured: Pre intervention baseline and post intervention at 10 weeks
Physical Activity Measured With Accelerometers
Number of Steps per day.
Measured: Pre intervention baseline and post intervention at 10 weeks
Structural Magnetic Resonance Imaging
Intervention dependent changes in brain structure i.e. gray matter volume measured as voxels Analyses defined as: were there any significant clusters of voxels explained by the interaction of group and time. In other words, were there significant changes in voxel activity that depended on the interventions when using a cluster-based threshold using group statistics..
Note that it is not possible to report this outcome per group. Additionally, MR statistics are not reported as measures of central tendency such as the mean or any alternatives provided.
Measured: Pre intervention baseline and post intervention at 10 weeks
Task-induced Brain Activity as Measured by Functional Magnetic Resonance Imaging
Intervention dependent changes in task-induced brain activity, voxel-wise analyses of whole brain. (Name of the task performed during fMRI; the serial reaction time task.)
Analyses defined as: were there any significant clusters of voxels explained by the interaction of group and time. In other words, were there significant changes in voxel activity that depended on the interventions when using a cluster-based threshold. The measure type number was chosen because we estimated the number of significant clusters of voxels. Group statistics were perfromed
Note that for task fMRI interaction analyses, there are no meaningful values to report for the groups respectively.
Measured: Pre intervention baseline and post intervention at 10 weeks
Wet Biomarkers
Mature Brain-derived neurotrophic factor (mBDNF) in serum
Measured: Pre intervention baseline and post intervention at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start15 Aug 2017
- Primary completion13 Dec 2019
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Erika Franzén, Karolinska Institutet
- Investigators
- Maria Eriksdotter, Professor, Study chair, Karolinska Institutet, NVS department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213873
- Sponsor's protocol ID
- 4-2872/2016
- Acronym
- BETA-PD
- Status last verified
- Feb 2025
- First submitted
- 5 Jul 2017
- Last updated
- 7 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently we do not have IRB for sharing.
Publications
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.
PubMed 23017069Conradsson 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.
PubMed 25608520Franzen 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.
PubMed 31718583Johansson 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.
PubMed 32300475Steurer H, Schalling E, Franzen E, Gustafsson JK, Albrecht F. Baseline predictors of response to a group-based speech and communication intervention in Parkinson's disease: A secondary analysis of a randomized controlled trial. J Parkinsons Dis. 2026 Aug;16(5):965-979. doi: 10.1177/1877718X261453191. Epub 2026 May 25.
PubMed 42183643Conklin SJ, Albrecht F, Hooyman A, Peterson D, Franzen E, Longhurst JK. Identifying Predictors of Discordance Between Balance Perception and Ability in Parkinson Disease. J Neurol Phys Ther. 2026 Oct 1;50(4):232-242. doi: 10.1097/NPT.0000000000000556. Epub 2026 Apr 17.
PubMed 41992280Steurer 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.
PubMed 40628546Ernst 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.
PubMed 38588457Moulaee Conradsson D, Leavy B, Hagstromer M, Franzen E. Predictors of Sustained Physical Activity During the COVID-19 Pandemic in People With Parkinson Disease in Sweden. J Neurol Phys Ther. 2024 Apr 1;48(2):75-82. doi: 10.1097/NPT.0000000000000455. Epub 2023 Jul 10.
PubMed 37436217Ernst 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.
PubMed 36602886Freidle 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.
PubMed 35064138Leavy 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.
PubMed 34369451Johansson 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.
PubMed 33719728