Physical Training for People With Parkinson's Disease and Multiple Sclerosis: Effect on Mind and Body
- Conditions
- Parkinson DiseaseMultiple Sclerosis
- Interventions
- Behavioral: Continuous Aerobic Training (CAT)Behavioral: Movement AdviceBehavioral: High Intensity Interval Training (HIIT)
- Registration Number
- NCT05357638
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Physical Training Group 2 (n=16) Continuous Aerobic Training (CAT) Continuous Aerobic Training Physical Training Group 3 (n=16) Movement Advice Movement Advice Physical Training Group 1 (n=16) High Intensity Interval Training (HIIT) High Intensity Interval Training
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 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 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 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 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
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 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 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 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 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 brain morphology Week 4, week 12 The effect of physical training on brain morphology, measured by structural magnetic resonance imaging (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 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 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 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., 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 brain connectivity Week 4, week 12 The effect of physical training on brain connectivity, measured by resting state functional 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)
Trial Locations
- Locations (1)
Amsterdam UMC, location VU medical center
🇳🇱Amsterdam, Noord-Holland, Netherlands