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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis; Parkinson Disease
• Intervention / Treatment: Behavioral: High Intensity Interval Training (HIIT); Behavioral: Continuous Aerobic Training (CAT); Behavioral: Movement Advice

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.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erwin EH van Wegen, Dr.; Phone Number: 020-4440461; Email: e.vanwegen@amsterdamumc.nl

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1081HZ
      • Recruiting
      • Amsterdam UMC, location VU Medical Center
      • Contact: Erwin EH van Wegen, Dr.; Phone Number: 020-4440461; Email: e.vanwegen@amsterdamumc.nl
      • Contact: Elvira S Amaral Gomes, MSc; Phone Number: 020-4444925; Email: e.s.amaralgomes@amsterdamumc.nl
      • Principal Investigator: Erwin EH van Wegen, Dr.
      • Sub-Investigator: Elvira S Amaral Gomes, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in anxiety and depressive symptoms	The effect of physical training on anxiety and depressive symptoms, measured by the Hospital Anxiety and Depression Scale	Baseline (week 0), week 4, week 12, week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in disease severity	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)	Baseline (week 0), week 4, week 12, week 16
Change in cognitive function (i.e., ability to inhibit cognitive interference)	The effect of physical training on cognitive function, measured by the Stroop Color Word Test	Baseline (week 0), week 4, week 12, week 16
Change in cognitive function (i.e., mental flexibility)	The effect of physical training on cognitive function, measured by the Trail Making Test	Baseline (week 0), week 4, week 12, week 16
Change in cognitive function (i.e., range of cognitive operations: motor speed, attention, and visuoperceptual functions)	The effect of physical training on cognitive function, measured by the Symbol Digit Modalities Test	Baseline (week 0), week 4, week 12, week 16
Change in fatigue	The effect of physical training on fatigue, measured by the Checklist Individual Strength fatigue sub-scale	Baseline (week 0), week 4, week 12, week 16
Change in sleep quality	The effect of physical training on sleep quality, measured by the Insomnia Severity Index	Baseline (week 0), week 4, week 12, week 16
Change in well-being	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)	Baseline (week 0), week 4, week 12, week 16
Change in quality of life	The effect of physical training on quality of life, measured by the Short Form health survey (36 items)	Baseline (week 0), week 4, week 12, week 16
Change in motor capacity (i.e., walking speed)	The effect of physical training on motor capacity, measured by the 10-Meter Walk Test	Baseline (week 0), week 4, week 12, week 16
Change in motor capacity (i.e., lower extremity function, mobility, and fall risk)	The effect of physical training on motor capacity, measured by the Timed Up and Go test	Baseline (week 0), week 4, week 12, week 16
Change in motor capacity (i.e., finger dexterity)	The effect of physical training on motor capacity, measured by the Nine Hole Peg Test	Baseline (week 0), week 4, week 12, week 16
Change in activities of daily living	The effect of physical training on activities of daily living, measured by the Nottingham Extended Activities of daily living Index	Baseline (week 0), week 4, week 12, week 16
Change in biomarkers of neuroplasticity in blood	The effect of physical training on biomarkers of neuroplasticity in blood, measured by Brain Derived Neurotrophic Factor concentration	Baseline (week 0), week 4, week 12, week 16
Change in biomarkers of neurodegeneration in blood	The effect of physical training on biomarkers of neurodegeneration in blood, measured by Neurofilament Light concentration	Baseline (week 0), week 4, week 12, week 16
Change in brain morphology	The effect of physical training on brain morphology, measured by structural magnetic resonance imaging (MRI)	Week 4, week 12
Change in structural brain connectivity	The effect of physical training on structural brain connectivity, measured by diffusion MRI + free-water content	Week 4, week 12
Change in brain connectivity	The effect of physical training on brain connectivity, measured by resting state functional MRI	Week 4, week 12
Change in brain iron concentration in the Substantia Nigra	The effect of physical training on brain iron concentration in the Substantia Nigra, measured by Quantitative Susceptibility Mapping methodology	Week 4, week 12
Change in brain neuromelanin content	The effect of physical training on brain neuromelanin content, measured by neuromelanin-sensitive MRI	Week 4, week 12
Change in daily mood	The effect of physical training on daily mood, measured by the Visual Analogue Scale (total sore range 0-10, higher score = better)	Weekly assessment from baseline to week 16
Change in daily anxiety	The effect of physical training on daily anxiety, measured by the Visual Analogue Scale (total sore range 0-10, higher score = better)	Weekly assessment from baseline to week 16
Change in daily ability to concentrate	The effect of physical training on daily ability to concentrate, measured by the Visual Analogue Scale (total sore range 0-10, higher score = better)	Weekly assessment from baseline to week 16
Change in daily fatigue	The effect of physical training on daily fatigue, measured by the Visual Analogue Scale (total sore range 0-10, higher score = better)	Weekly assessment from baseline to week 16
Change in daily sleep quality	The effect of physical training on daily sleep quality, measured by the Visual Analogue Scale (total sore range 0-10, higher score = better)	Weekly assessment from baseline to week 16

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Collaborators: Netherlands Brain Foundation
• Investigators: Principal Investigator: Erwin EH van Wegen, Dr., Amsterdam UMC, location VUmc

Publications and helpful links

Helpful Links

• Website of the trial

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Anticipated): May 2, 2025
• Study Completion (Anticipated): November 2, 2025

Study Registration Dates

• First Submitted: April 12, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Multiple Sclerosis; Sclerosis; Parkinson Disease
• Other Study ID Numbers: NL78096.029.21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No