Clinical trial NCT05357638: Physical Training for People With Parkinson's Disease and Multiple Sclerosis: Effect on Mind and Body
Official title: Physical Training for People With Parkinson's Disease and Multiple Sclerosis: Effect on Mind and Body
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Multiple Sclerosis
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: Netherlands Brain Foundation
First posted: 2022-05-03
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in anxiety and depressive symptoms
timeFrame: Baseline (week 0), week 4, week 12, week 16
Secondary outcomes:
measure: Change in disease severity
timeFrame: Baseline (week 0), week 4, week 12, week 16
measure: Change in cognitive function (i.e., ability to inhibit cognitive interference)
timeFrame: Baseline (week 0), week 4, week 12, week 16
measure: Change in cognitive function (i.e., mental flexibility)
timeFrame: Baseline (week 0), week 4, week 12, week 16
measure: Change in cognitive function (i.e., range of cognitive operations: motor speed, attention, and visuoperceptual functions)
timeFrame: Baseline (week 0), week 4, week 12, week 16
measure: Change in fatigue
timeFrame: Baseline (week 0), week 4, week 12, week 16
measure: Change in sleep quality
timeFrame: Baseline (week 0), week 4, week 12, week 16
measure: Change in well-being
timeFrame: Baseline (week 0), week 4, week 12, week 16
measure: Change in quality of life
timeFrame: Baseline (week 0), week 4, week 12, week 16
measure: Change in motor capacity (i.e., walking speed)
timeFrame: Baseline (week 0), week 4, week 12, week 16
measure: Change in motor capacity (i.e., lower extremity function, mobility, and fall risk)
timeFrame: Baseline (week 0), week 4, week 12, week 16
measure: Change in motor capacity (i.e., finger dexterity)
timeFrame: Baseline (week 0), week 4, week 12, week 16
measure: Change in activities of daily living
timeFrame: Baseline (week 0), week 4, week 12, week 16
measure: Change in biomarkers of neuroplasticity in blood
timeFrame: Baseline (week 0), week 4, week 12, week 16
measure: Change in biomarkers of neurodegeneration in blood
timeFrame: Baseline (week 0), week 4, week 12, week 16
measure: Change in brain morphology
timeFrame: Week 4, week 12
measure: Change in structural brain connectivity
timeFrame: Week 4, week 12
measure: Change in brain connectivity
timeFrame: Week 4, week 12
measure: Change in brain iron concentration in the Substantia Nigra
timeFrame: Week 4, week 12
measure: Change in brain neuromelanin content
timeFrame: Week 4, week 12
measure: Change in daily mood
timeFrame: Weekly assessment from baseline to week 16
measure: Change in daily anxiety
timeFrame: Weekly assessment from baseline to week 16
measure: Change in daily ability to concentrate
timeFrame: Weekly assessment from baseline to week 16
measure: Change in daily fatigue
timeFrame: Weekly assessment from baseline to week 16
measure: Change in daily sleep quality
timeFrame: Weekly assessment from baseline to week 16
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location VU medical center
state: Noord-Holland
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Erwin EH van Wegen, Dr.
role: PRINCIPAL_INVESTIGATOR
References: