Evidence map›Paper›PMID 31718583›Full record

ArticleBMC neurology2019

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.

Erika Franzén, Hanna Johansson, Malin Freidle, Urban Ekman, Martin Benka Wallén, Ellika Schalling, Alexander Lebedev, Martin Lövdén, Staffan Holmin, Per Svenningsson and 1 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC neurology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03213873 (Effects of the HiBalance-program), which is not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03213873 nacompletednot on this map

Effects of the HiBalance-program: Linking Clinical Signs and Symptoms to Changes in the Brain in People With Parkinson´s Disease

TypeinterventionalSponsorKarolinska InstitutetRan2017 to 2019Enrolled95ConditionsParkinson Disease, Physical Activity, Gait Disorders, Neurologic, Neural DegenerationArmsHiBalance, Speech and communication therapy
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Erika FranzénDepartment of Neurobiology, Care sciences and Society, Division of Physiotherapy, Karolinska Institutet, Stockholm, Sweden. erika.franzen@ki.se.ORCID http://orcid.org/0000-0001-5520-544X
Hanna JohanssonDepartment of Neurobiology, Care sciences and Society, Division of Physiotherapy, Karolinska Institutet, Stockholm, Sweden.
Malin FreidleDepartment of Neurobiology, Care sciences and Society, Division of Physiotherapy, Karolinska Institutet, Stockholm, Sweden.
Urban EkmanStockholms Sjukhem, R&D unit, Stockholm, Sweden.
Martin Benka WallénDepartment of Neurobiology, Care sciences and Society, Division of Physiotherapy, Karolinska Institutet, Stockholm, Sweden.
Ellika SchallingDepartment of Clinical Science, Intervention and Technology, CLINTEC, Division of Speech and Language Pathology, Karolinska Institutet, Stockholm, Sweden.
Alexander LebedevDepartment of Neurobiology, Care sciences and Society, Aging Research Center, Karolinska Institutet, Stockholm, Sweden.
Martin LövdénDepartment of Neurobiology, Care sciences and Society, Aging Research Center, Karolinska Institutet, Stockholm, Sweden.
Staffan HolminDepartment of Clinical Neuroscience, Division of Neurology, Karolinska Institutet, Stockholm, Sweden.
Per SvenningssonDepartment of Clinical Neuroscience, Division of Neurology, Karolinska Institutet, Stockholm, Sweden.
Maria HagströmerDepartment of Neurobiology, Care sciences and Society, Division of Physiotherapy, Karolinska Institutet, Stockholm, Sweden.

Funding

Karolinska Institutet N/AParkinson's Research Foundation (SE) N/AStockholms Läns Landsting (SE) Regional Agreement on Medical Training and Clinical Research between Stockholm County Council and Karolinska Institutet (ALF) SLL20160044 and SLL20170073Vetenskapsrådet 2016-01965
6 · The paper itself

Abstract

backgroundParkinson's disease (PD) affects many physiological systems essential for balance control. Recent studies suggest that intensive and cognitively demanding physical exercise programs are capable of inducing plastic brain changes in PD. We have developed a highly challenging balance training (the HiBalance) program that emphasizes critical aspects of balance control through progressively introducing more challenging exercises which incorporates dual-tasking. Earlier studies have shown it to be effective in improving balance, gait and dual-tasking. The study design has thereafter been adjusted to link intervention-induced behavioral changes to brain morphology and function. Specifically, in this randomized controlled trial, we will determine the effects of the HiBalance program on balance, gait and cognition and relate this to task-evoked functional MRI (fMRI), as well as brain-derived neurotrophic factor (BDNF) in participants with mild-moderate PD.

methodsOne hundred participants with idiopathic PD, Hoehn & Yahr stage 2 or 3, ≥ 60 years of age, ≥ 21 on Montreal Cognitive Assessment will be recruited in successive waves and randomized into either the HiBalance program or to an active control group (the HiCommunication program, targeting speech and communication). Both interventions will be performed in small groups, twice a week with 1 h sessions for 10 weeks. In addition, a 1 h, once a week, home exercise program will also be performed. A double-blinded design will be used. At the pre- and post-assessments, participants will be assessed on balance (main outcome), gait, cognitive functions, physical activity, voice/speech function, BDNF in serum and fMRI (3 T Philips) during performance of motor-cognitive tasks. DISCUSSION: Since there is currently no cure for PD, findings of neuroplastic brain changes in response to exercise would revolutionize the way we treat PD, and, in turn, provide new hope to patients for a life with better health, greater independence and improved quality of life.

trial registrationClincalTrials.gov: NCT03213873, first posted July 11, 2017.

Indexed as

Neuronal PlasticityResearch DesignAgedBrainDouble-Blind MethodExercise TherapyFemaleHumansMaleMiddle AgedParkinson DiseasePostural BalanceQuality of LifeRandomized Controlled Trials as TopicBalanceCognitionDual-taskExerciseGaitImagingMagnetic resonance neural growth factorNeuroplasticityParkinson’s disease

Identifiers

PMID31718583
PMCPMC6849188

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.