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

Multiple Sclerosis Clinical Trial

— HersenFIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05357638
• Other study ID #: NL78096.029.21
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2022
• Est. completion date: November 2, 2025

Study information

• Verified date: April 2023
• Source: Amsterdam UMC, location VUmc
• Contact: Erwin EH van Wegen, Dr.
• Phone: 020-4440461
• Email: e.vanwegen[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: November 2, 2025
• Est. primary completion date: May 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Parkinson Disease
• Sclerosis

Intervention

Behavioral:
• High Intensity Interval Training (HIIT)
8 weeks of HIIT, 2x/week for about 30 minutes/session on a cycle ergometer
• Continuous Aerobic Training (CAT)
8 weeks of CAT, 2x/week for about 50 minutes/session on a cycle ergometer
• 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

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, location VU medical center	Amsterdam	Noord-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc	Netherlands Brain Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in brain morphology	The effect of physical training on brain morphology, measured by structural magnetic resonance imaging (MRI)	Week 4, week 12
Secondary	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
Secondary	Change in brain connectivity	The effect of physical training on brain connectivity, measured by resting state functional MRI	Week 4, week 12
Secondary	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
Secondary	Change in brain neuromelanin content	The effect of physical training on brain neuromelanin content, measured by neuromelanin-sensitive MRI	Week 4, week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Website of the trial