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

April 24, 2023 updated by: Dr. Erwin E. H. van Wegen, Amsterdam UMC, location VUmc
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081HZ
        • Recruiting
        • Amsterdam UMC, location VU Medical center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Erwin EH van Wegen, Dr.
        • Sub-Investigator:
          • Elvira S Amaral Gomes, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Physical Training Group 1 (n=16)
High Intensity Interval Training
Behavioral: High Intensity Interval Training (HIIT)
8 weeks of HIIT, 2x/week for about 30 minutes/session on a cycle ergometer
Experimental: Physical Training Group 2 (n=16)
Continuous Aerobic Training
Behavioral: Continuous Aerobic Training (CAT)
8 weeks of CAT, 2x/week for about 50 minutes/session on a cycle ergometer
Experimental: Physical Training Group 3 (n=16)
Movement Advice
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in anxiety and depressive symptoms
Time Frame: 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
Baseline (week 0), week 4, week 12, week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in disease severity
Time Frame: 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)
Baseline (week 0), week 4, week 12, week 16
Change in cognitive function (i.e., ability to inhibit cognitive interference)
Time Frame: Baseline (week 0), week 4, week 12, week 16
The effect of physical training on cognitive function, measured by the Stroop Color Word Test
Baseline (week 0), week 4, week 12, week 16
Change in cognitive function (i.e., mental flexibility)
Time Frame: Baseline (week 0), week 4, week 12, week 16
The effect of physical training on cognitive function, measured by the Trail Making Test
Baseline (week 0), week 4, week 12, week 16
Change in cognitive function (i.e., range of cognitive operations: motor speed, attention, and visuoperceptual functions)
Time Frame: Baseline (week 0), week 4, week 12, week 16
The effect of physical training on cognitive function, measured by the Symbol Digit Modalities Test
Baseline (week 0), week 4, week 12, week 16
Change in fatigue
Time Frame: 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
Baseline (week 0), week 4, week 12, week 16
Change in sleep quality
Time Frame: Baseline (week 0), week 4, week 12, week 16
The effect of physical training on sleep quality, measured by the Insomnia Severity Index
Baseline (week 0), week 4, week 12, week 16
Change in well-being
Time Frame: 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)
Baseline (week 0), week 4, week 12, week 16
Change in quality of life
Time Frame: 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)
Baseline (week 0), week 4, week 12, week 16
Change in motor capacity (i.e., walking speed)
Time Frame: Baseline (week 0), week 4, week 12, week 16
The effect of physical training on motor capacity, measured by the 10-Meter Walk Test
Baseline (week 0), week 4, week 12, week 16
Change in motor capacity (i.e., lower extremity function, mobility, and fall risk)
Time Frame: 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
Baseline (week 0), week 4, week 12, week 16
Change in motor capacity (i.e., finger dexterity)
Time Frame: Baseline (week 0), week 4, week 12, week 16
The effect of physical training on motor capacity, measured by the Nine Hole Peg Test
Baseline (week 0), week 4, week 12, week 16
Change in activities of daily living
Time Frame: 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
Baseline (week 0), week 4, week 12, week 16
Change in biomarkers of neuroplasticity in blood
Time Frame: 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
Baseline (week 0), week 4, week 12, week 16
Change in biomarkers of neurodegeneration in blood
Time Frame: 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
Baseline (week 0), week 4, week 12, week 16
Change in brain morphology
Time Frame: Week 4, week 12
The effect of physical training on brain morphology, measured by structural magnetic resonance imaging (MRI)
Week 4, week 12
Change in structural brain connectivity
Time Frame: Week 4, week 12
The effect of physical training on structural brain connectivity, measured by diffusion MRI + free-water content
Week 4, week 12
Change in brain connectivity
Time Frame: Week 4, week 12
The effect of physical training on brain connectivity, measured by resting state functional MRI
Week 4, week 12
Change in brain iron concentration in the Substantia Nigra
Time Frame: Week 4, week 12
The effect of physical training on brain iron concentration in the Substantia Nigra, measured by Quantitative Susceptibility Mapping methodology
Week 4, week 12
Change in brain neuromelanin content
Time Frame: Week 4, week 12
The effect of physical training on brain neuromelanin content, measured by neuromelanin-sensitive MRI
Week 4, week 12
Change in daily mood
Time Frame: 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)
Weekly assessment from baseline to week 16
Change in daily anxiety
Time Frame: 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)
Weekly assessment from baseline to week 16
Change in daily ability to concentrate
Time Frame: 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)
Weekly assessment from baseline to week 16
Change in daily fatigue
Time Frame: 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)
Weekly assessment from baseline to week 16
Change in daily sleep quality
Time Frame: 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)
Weekly assessment from baseline to week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amsterdam UMC, location VUmc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Netherlands Brain Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Erwin EH van Wegen, Dr., Amsterdam UMC, location VUmc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 2, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 2, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL78096.029.21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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