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

Primary Purpose

Parkinson Disease, Multiple Sclerosis

Status

Recruiting

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

High Intensity Interval Training (HIIT)

Continuous Aerobic Training (CAT)

Movement Advice

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Amsterdam UMC, location VU medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Physical Training Group 1 (n=16)

Physical Training Group 2 (n=16)

Physical Training Group 3 (n=16)

Arm Description

High Intensity Interval Training

Continuous Aerobic Training

Movement Advice

Outcomes

Primary Outcome Measures

Change in anxiety and depressive symptoms

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

Secondary Outcome Measures

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)

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

Change in cognitive function (i.e., mental flexibility)

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)

The effect of physical training on cognitive function, measured by the Symbol Digit Modalities Test

Change in fatigue

The effect of physical training on fatigue, measured by the Checklist Individual Strength fatigue sub-scale

Change in sleep quality

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

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)

Change in quality of life

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)

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)

The effect of physical training on motor capacity, measured by the Timed Up and Go test

Change in motor capacity (i.e., finger dexterity)

The effect of physical training on motor capacity, measured by the Nine Hole Peg Test

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

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

Change in biomarkers of neurodegeneration in blood

The effect of physical training on biomarkers of neurodegeneration in blood, measured by Neurofilament Light concentration

Change in brain morphology

The effect of physical training on brain morphology, measured by structural magnetic resonance imaging (MRI)

Change in structural brain connectivity

The effect of physical training on structural brain connectivity, measured by diffusion MRI + free-water content

Change in brain connectivity

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

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

Change in brain neuromelanin content

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

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)

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)

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)

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)

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)

Full Information

NCT ID

NCT05357638

First Posted

April 12, 2022

Last Updated

April 24, 2023

Sponsor

Amsterdam UMC, location VUmc

Collaborators

Netherlands Brain Foundation

1. Study Identification

Unique Protocol Identification Number

NCT05357638

Brief Title

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

Acronym

HersenFIT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 2, 2022 (Actual)

Primary Completion Date

May 2, 2025 (Anticipated)

Study Completion Date

November 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Amsterdam UMC, location VUmc

Collaborators

Netherlands Brain Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease, Multiple Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Physical Training Group 1 (n=16)

Arm Type

Experimental

Arm Description

High Intensity Interval Training

Arm Title

Physical Training Group 2 (n=16)

Arm Type

Experimental

Arm Description

Continuous Aerobic Training

Arm Title

Physical Training Group 3 (n=16)

Arm Type

Experimental

Arm Description

Movement Advice

Intervention Type

Behavioral

Intervention Name(s)

High Intensity Interval Training (HIIT)

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Continuous Aerobic Training (CAT)

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Movement Advice

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in anxiety and depressive symptoms

Description

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

Time Frame