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Physical Training for People With Parkinson's Disease and Multiple Sclerosis: Effect on Mind and Body (HersenFIT)

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ClinicalTrials.gov Identifier: NCT05357638
Recruitment Status : Recruiting
First Posted : May 3, 2022
Last Update Posted : May 9, 2022
Sponsor:
Collaborator:
Netherlands Brain Foundation
Information provided by (Responsible Party):
Dr. Erwin E. H. van Wegen, Amsterdam UMC, location VUmc

Brief Summary:
People with Parkinson's disease and Multiple Sclerosis experience disabling motor and non-motor symptoms, which respond insufficiently to medication. To adequately alleviate disease burden, physical training is increasing acknowledged as an assisting therapy; however, the optimal dose of exercise in unknown.

Condition or disease Intervention/treatment Phase
Parkinson Disease Multiple Sclerosis Behavioral: High Intensity Interval Training (HIIT) Behavioral: Continuous Aerobic Training (CAT) Behavioral: Movement Advice Not Applicable

Detailed Description:
Next to complex motor deficits, people with Parkinson's disease and Multiple Sclerosis experience highly disabling non-motor symptoms; for example, anxiety and depression, cognitive decline, fatigue, and sleep problems. Physical training is increasingly recognized as an assisting and, importantly, safe therapy for these patients to alleviate disease burden. However, the optimal dose (i.e., type, frequency, intensity, duration) of exercise has not yet been established. This study aims to investigate differences in response patterns of motor and non-motor symptoms, blood-based biomarkers of neuroplasticity and neurodegeneration, as well as functional brain connectivity to eight weeks of high intensity interval training [2x/week, ~30 min/session], continuous aerobic training [2x/week, ~50 min/session], or movement advice [+3000 steps/day for 5 days/week monitored with an activity tracker]. Frequently repeated assessment of outcomes measures will be conducted.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physical Training for People With Parkinson's Disease and Multiple Sclerosis: Effect on Mind and Body
Estimated Study Start Date : May 2, 2022
Estimated Primary Completion Date : May 2, 2025
Estimated Study Completion Date : November 2, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physical Training Group 1 (n=16)
High Intensity Interval Training
Behavioral: High Intensity Interval Training (HIIT)
8 weeks of HIIT, 2x/week for about 30 minutes/session on a cycle ergometer

Experimental: Physical Training Group 2 (n=16)
Continuous Aerobic Training
Behavioral: Continuous Aerobic Training (CAT)
8 weeks of CAT, 2x/week for about 50 minutes/session on a cycle ergometer

Experimental: Physical Training Group 3 (n=16)
Movement Advice
Behavioral: Movement Advice
Weekly step goal, monitored using an activity tracker, +3000 steps/day for 5 days/week, step goal is based on average step count in the 4 weeks of baseline prior to the intervention




Primary Outcome Measures :
  1. Change in anxiety and depressive symptoms [ Time Frame: Baseline (week 0), week 4, week 12, week 16 ]
    The effect of physical training on anxiety and depressive symptoms, measured by the Hospital Anxiety and Depression Scale


Secondary Outcome Measures :
  1. Change in disease severity [ Time Frame: Baseline (week 0), week 4, week 12, week 16 ]
    The effect of physical training on disease severity, measured by the Unified Parkinson's Disease Rating Scale (Parkinson's disease) (total score range 0-199, higher score = worse) or Expanded Disability Status Scale (Multiple Sclerosis)

  2. Change in cognitive function (i.e., ability to inhibit cognitive interference) [ Time Frame: Baseline (week 0), week 4, week 12, week 16 ]
    The effect of physical training on cognitive function, measured by the Stroop Color Word Test

  3. Change in cognitive function (i.e., mental flexibility) [ Time Frame: Baseline (week 0), week 4, week 12, week 16 ]
    The effect of physical training on cognitive function, measured by the Trail Making Test

  4. Change in cognitive function (i.e., range of cognitive operations: motor speed, attention, and visuoperceptual functions) [ Time Frame: Baseline (week 0), week 4, week 12, week 16 ]
    The effect of physical training on cognitive function, measured by the Symbol Digit Modalities Test

  5. Change in fatigue [ Time Frame: Baseline (week 0), week 4, week 12, week 16 ]
    The effect of physical training on fatigue, measured by the Checklist Individual Strength fatigue sub-scale

  6. Change in sleep quality [ Time Frame: Baseline (week 0), week 4, week 12, week 16 ]
    The effect of physical training on sleep quality, measured by the Insomnia Severity Index

  7. Change in well-being [ Time Frame: Baseline (week 0), week 4, week 12, week 16 ]
    The effect of physical training on well-being, measured by the Parkinson's Disease Questionnaire (8 items) (Parkinson's disease) or Multiple Sclerosis Impact Scale (29 items) (Multiple Sclerosis)

  8. Change in quality of life [ Time Frame: Baseline (week 0), week 4, week 12, week 16 ]
    The effect of physical training on quality of life, measured by the Short Form health survey (36 items)

  9. Change in motor capacity (i.e., walking speed) [ Time Frame: Baseline (week 0), week 4, week 12, week 16 ]
    The effect of physical training on motor capacity, measured by the 10-Meter Walk Test

  10. Change in motor capacity (i.e., lower extremity function, mobility, and fall risk) [ Time Frame: Baseline (week 0), week 4, week 12, week 16 ]
    The effect of physical training on motor capacity, measured by the Timed Up and Go test

  11. Change in motor capacity (i.e., finger dexterity) [ Time Frame: Baseline (week 0), week 4, week 12, week 16 ]
    The effect of physical training on motor capacity, measured by the Nine Hole Peg Test

  12. Change in activities of daily living [ Time Frame: Baseline (week 0), week 4, week 12, week 16 ]
    The effect of physical training on activities of daily living, measured by the Nottingham Extended Activities of daily living Index

  13. Change in biomarkers of neuroplasticity in blood [ Time Frame: Baseline (week 0), week 4, week 12, week 16 ]
    The effect of physical training on biomarkers of neuroplasticity in blood, measured by Brain Derived Neurotrophic Factor concentration

  14. Change in biomarkers of neurodegeneration in blood [ Time Frame: Baseline (week 0), week 4, week 12, week 16 ]
    The effect of physical training on biomarkers of neurodegeneration in blood, measured by Neurofilament Light concentration

  15. Change in brain morphology [ Time Frame: Week 4, week 12 ]
    The effect of physical training on brain morphology, measured by structural magnetic resonance imaging (MRI)

  16. Change in structural brain connectivity [ Time Frame: Week 4, week 12 ]
    The effect of physical training on structural brain connectivity, measured by diffusion MRI + free-water content

  17. Change in brain connectivity [ Time Frame: Week 4, week 12 ]
    The effect of physical training on brain connectivity, measured by resting state functional MRI

  18. Change in brain iron concentration in the Substantia Nigra [ Time Frame: Week 4, week 12 ]
    The effect of physical training on brain iron concentration in the Substantia Nigra, measured by Quantitative Susceptibility Mapping methodology

  19. Change in brain neuromelanin content [ Time Frame: Week 4, week 12 ]
    The effect of physical training on brain neuromelanin content, measured by neuromelanin-sensitive MRI

  20. Change in daily mood [ Time Frame: Weekly assessment from baseline to week 16 ]
    The effect of physical training on daily mood, measured by the Visual Analogue Scale (total sore range 0-10, higher score = better)

  21. Change in daily anxiety [ Time Frame: Weekly assessment from baseline to week 16 ]
    The effect of physical training on daily anxiety, measured by the Visual Analogue Scale (total sore range 0-10, higher score = better)

  22. Change in daily ability to concentrate [ Time Frame: Weekly assessment from baseline to week 16 ]
    The effect of physical training on daily ability to concentrate, measured by the Visual Analogue Scale (total sore range 0-10, higher score = better)

  23. Change in daily fatigue [ Time Frame: Weekly assessment from baseline to week 16 ]
    The effect of physical training on daily fatigue, measured by the Visual Analogue Scale (total sore range 0-10, higher score = better)

  24. Change in daily sleep quality [ Time Frame: Weekly assessment from baseline to week 16 ]
    The effect of physical training on daily sleep quality, measured by the Visual Analogue Scale (total sore range 0-10, higher score = better)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Parkinson's Disease (PD) or Progressive Multiple Sclerosis (MS)
  • Hoehn & Yahr stage <4 (PD), Expanded Disability Status Scale score <6 (MS)
  • Anxiety and/or depressive symptoms; Hospital Anxiety and Depression Scale (HADS) score >=8 points on HADS-A and/or HADS-D
  • Sufficient cognitive ability to understand training instructions; Montreal Cognitive Assessment score >21 points
  • Able to participate in intensive physical training, no contra-indications for exercise
  • Stable medication regime for at least 4 weeks prior to inclusion
  • Age >=18 years

Exclusion Criteria:

  • Participation in intensive exercise program in the month prior to inclusion
  • Relapse in the month prior to inclusion (MS)
  • Symptoms indicating cardiovascular, pulmonary, or metabolic disease or cardiovascular, pulmonary, or metabolic disease which are not under control with medication
  • abnormal electrocardiography in rest

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05357638


Contacts
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Contact: Erwin EH van Wegen, Dr. 020-4440461 e.vanwegen@amsterdamumc.nl

Locations
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Netherlands
Amsterdam UMC, location VU medical center Recruiting
Amsterdam, Noord-Holland, Netherlands, 1081HZ
Contact: Erwin EH van Wegen, Dr.    020-4440461    e.vanwegen@amsterdamumc.nl   
Contact: Elvira S Amaral Gomes, MSc    020-4444925    e.s.amaralgomes@amsterdamumc.nl   
Principal Investigator: Erwin EH van Wegen, Dr.         
Sub-Investigator: Elvira S Amaral Gomes, MSc         
Sponsors and Collaborators
Amsterdam UMC, location VUmc
Netherlands Brain Foundation
Investigators
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Principal Investigator: Erwin EH van Wegen, Dr. Amsterdam UMC, location VUmc
Additional Information:
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Responsible Party: Dr. Erwin E. H. van Wegen, Principal Investigator, Associate Professor Neurorehabilitation, Amsterdam UMC, location VUmc
ClinicalTrials.gov Identifier: NCT05357638    
Other Study ID Numbers: NL78096.029.21
First Posted: May 3, 2022    Key Record Dates
Last Update Posted: May 9, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Multiple Sclerosis
Sclerosis
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases