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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.BN

Abstract

BACKGROUND

Parkinson'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.

METHODS

One 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 REGISTRATION

ClincalTrials.gov: NCT03213873, first posted July 11, 2017.

Authors+Show Affiliations

Department of Neurobiology, Care sciences and Society, Division of Physiotherapy, Karolinska Institutet, Stockholm, Sweden. erika.franzen@ki.se. Karolinska University Hospital, Allied Health Professionals Function, Function Area Occupational Therapy & Physiotherapy, Stockholm, Sweden. erika.franzen@ki.se. Stockholms Sjukhem, R&D unit, Stockholm, Sweden. erika.franzen@ki.se.Department of Neurobiology, Care sciences and Society, Division of Physiotherapy, Karolinska Institutet, Stockholm, Sweden. Karolinska University Hospital, Allied Health Professionals Function, Function Area Occupational Therapy & Physiotherapy, Stockholm, Sweden.Department of Neurobiology, Care sciences and Society, Division of Physiotherapy, Karolinska Institutet, Stockholm, Sweden.Stockholms Sjukhem, R&D unit, Stockholm, Sweden. Department of Neurobiology, Care sciences and Society, Division of Clinical Geriatrics, Karolinska Institutet, Stockholm, Sweden. Karolinska University Hospital, Allied Health Professionals Function, Function Area Medical Psychology, Stockholm, Sweden.Department of Neurobiology, Care sciences and Society, Division of Physiotherapy, Karolinska Institutet, Stockholm, Sweden.Department of Clinical Science, Intervention and Technology, CLINTEC, Division of Speech and Language Pathology, Karolinska Institutet, Stockholm, Sweden. Karolinska University Hospital, Allied Health Professionals Function, Function Area Speech and Language Pathology, Stockholm, Sweden.Department of Neurobiology, Care sciences and Society, Aging Research Center, Karolinska Institutet, Stockholm, Sweden. Department of Clinical Neuroscience, Division of Neurology, Karolinska Institutet, Stockholm, Sweden.Department of Neurobiology, Care sciences and Society, Aging Research Center, Karolinska Institutet, Stockholm, Sweden.Department of Clinical Neuroscience, Division of Neurology, Karolinska Institutet, Stockholm, Sweden.Department of Clinical Neuroscience, Division of Neurology, Karolinska Institutet, Stockholm, Sweden.Department of Neurobiology, Care sciences and Society, Division of Physiotherapy, Karolinska Institutet, Stockholm, Sweden. Karolinska University Hospital, Allied Health Professionals Function, Function Area Occupational Therapy & Physiotherapy, Stockholm, Sweden. Department of Health Promoting Science, Sophiahemmet University, Stockholm, Sweden.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

31718583

Citation

Franzén, Erika, et al. "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 Neurology, vol. 19, no. 1, 2019, p. 280.
Franzén E, Johansson H, Freidle M, et al. 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;19(1):280.
Franzén, E., Johansson, H., Freidle, M., Ekman, U., Wallén, M. B., Schalling, E., Lebedev, A., Lövdén, M., Holmin, S., Svenningsson, P., & Hagströmer, M. (2019). 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 Neurology, 19(1), 280. https://doi.org/10.1186/s12883-019-1520-2
Franzén E, et al. 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. PubMed PMID: 31718583.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Franzén,Erika, AU - Johansson,Hanna, AU - Freidle,Malin, AU - Ekman,Urban, AU - Wallén,Martin Benka, AU - Schalling,Ellika, AU - Lebedev,Alexander, AU - Lövdén,Martin, AU - Holmin,Staffan, AU - Svenningsson,Per, AU - Hagströmer,Maria, Y1 - 2019/11/12/ PY - 2019/08/16/received PY - 2019/10/30/accepted PY - 2019/11/14/entrez PY - 2019/11/14/pubmed PY - 2020/1/28/medline KW - Balance KW - Cognition KW - Dual-task KW - Exercise KW - Gait KW - Imaging KW - Magnetic resonance neural growth factor KW - Neuroplasticity KW - Parkinson’s disease SP - 280 EP - 280 JF - BMC neurology JO - BMC Neurol VL - 19 IS - 1 N2 - BACKGROUND: Parkinson'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. METHODS: One 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 REGISTRATION: ClincalTrials.gov: NCT03213873, first posted July 11, 2017. SN - 1471-2377 UR - https://www.unboundmedicine.com/medline/citation/31718583/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_ L2 - https://bmcneurol.biomedcentral.com/articles/10.1186/s12883-019-1520-2 DB - PRIME DP - Unbound Medicine ER -