Multiple Sclerosis, Parkinson Disease
Conditions
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.
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.
Interventions
BEHAVIORALHigh Intensity Interval Training (HIIT)
8 weeks of HIIT, 2x/week for about 30 minutes/session on a cycle ergometer
BEHAVIORALContinuous Aerobic Training (CAT)
8 weeks of CAT, 2x/week for about 50 minutes/session on a cycle ergometer
BEHAVIORALMovement 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
Sponsors
Netherlands Brain Foundation
Amsterdam UMC, location VUmc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in anxiety and depressive symptoms | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in cognitive function (i.e., ability to inhibit cognitive interference) | Baseline (week 0), week 4, week 12, week 16 | The effect of physical training on cognitive function, measured by the Stroop Color Word Test |
| Change in cognitive function (i.e., mental flexibility) | Baseline (week 0), week 4, week 12, week 16 | The effect of physical training on cognitive function, measured by the Trail Making Test |
| Change in cognitive function (i.e., range of cognitive operations: motor speed, attention, and visuoperceptual functions) | Baseline (week 0), week 4, week 12, week 16 | The effect of physical training on cognitive function, measured by the Symbol Digit Modalities Test |
| Change in fatigue | 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 |
| Change in sleep quality | Baseline (week 0), week 4, week 12, week 16 | The effect of physical training on sleep quality, measured by the Insomnia Severity Index |
| Change in well-being | 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) |
| Change in quality of life | 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) |
| Change in motor capacity (i.e., walking speed) | Baseline (week 0), week 4, week 12, week 16 | The effect of physical training on motor capacity, measured by the 10-Meter Walk Test |
| Change in motor capacity (i.e., lower extremity function, mobility, and fall risk) | 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 |
| Change in motor capacity (i.e., finger dexterity) | Baseline (week 0), week 4, week 12, week 16 | The effect of physical training on motor capacity, measured by the Nine Hole Peg Test |
| Change in activities of daily living | 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 |
| Change in disease severity | 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) |
| Change in biomarkers of neurodegeneration in blood | 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 |
| Change in brain morphology | Week 4, week 12 | The effect of physical training on brain morphology, measured by structural magnetic resonance imaging (MRI) |
| Change in structural brain connectivity | Week 4, week 12 | The effect of physical training on structural brain connectivity, measured by diffusion MRI + free-water content |
| Change in brain connectivity | Week 4, week 12 | The effect of physical training on brain connectivity, measured by resting state functional MRI |
| Change in brain iron concentration in the Substantia Nigra | Week 4, week 12 | The effect of physical training on brain iron concentration in the Substantia Nigra, measured by Quantitative Susceptibility Mapping methodology |
| Change in brain neuromelanin content | Week 4, week 12 | The effect of physical training on brain neuromelanin content, measured by neuromelanin-sensitive MRI |
| Change in daily mood | 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) |
| Change in daily anxiety | 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) |
| Change in daily ability to concentrate | 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) |
| Change in daily fatigue | 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) |
| Change in daily sleep quality | 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) |
| Change in biomarkers of neuroplasticity in blood | 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 |
Countries
Netherlands
Contacts
Primary ContactErwin EH van Wegen, Dr.
Outcome results
None listed