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

Amsterdam UMC, location VUmc48 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Parkinson Disease Multiple Sclerosis

Interventions

High Intensity Interval Training (HIIT)BEHAVIORAL

8 weeks of HIIT, 2x/week for about 30 minutes/session on a cycle ergometer

Continuous Aerobic Training (CAT)BEHAVIORAL

8 weeks of CAT, 2x/week for about 50 minutes/session on a cycle ergometer

Movement AdviceBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Amsterdam UMC, location VU medical center

Amsterdam, North Holland, Netherlands

RECRUITING

Outcomes

Primary Outcomes

Change in anxiety and depressive symptoms

The effect of physical training on anxiety and depressive symptoms, measured by the Hospital Anxiety and Depression Scale

Time frame: Baseline (week 0), week 4, week 12, week 16

Secondary Outcomes

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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Baseline (week 0), week 4, week 12, week 16

Central Contacts

Erwin EH van Wegen, Dr.

CONTACT

020-4440461 e.vanwegen@amsterdamumc.nl

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Change in sleep quality

The effect of physical training on sleep quality, measured by the Insomnia Severity Index

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: Week 4, week 12

Change in brain connectivity

The effect of physical training on brain connectivity, measured by resting state functional MRI

Time frame: 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

Time frame: Week 4, week 12

Change in brain neuromelanin content

The effect of physical training on brain neuromelanin content, measured by neuromelanin-sensitive MRI

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: Weekly assessment from baseline to week 16