Parkinson DiseaseHersenFITNCT05357638
Physical Training for People With Parkinson's Disease and Multiple Sclerosis: Effect on Mind and Body
A study testing High Intensity Interval Training (HIIT), Continuous Aerobic Training (CAT) and Movement Advice in people with Parkinson Disease and Multiple Sclerosis, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Multiple Sclerosis
- What is being tested?
- High Intensity Interval Training (HIIT), Continuous Aerobic Training (CAT) and Movement Advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 May 2022to 2 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC, location VU medical center
Amsterdam, North Holland, 1081HZ
Erwin EH van Wegen, Dr., 020-4440461, e.vanwegen@amsterdamumc.nl
Elvira S Amaral Gomes, MSc, 020-4444925, e.s.amaralgomes@amsterdamumc.nl
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease, Multiple Sclerosis
- Being tested
- High Intensity Interval Training (HIIT), Continuous Aerobic Training (CAT), Movement Advice
- Medical subject headings
- Parkinson Disease, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval Training (HIIT)Behavioural
8 weeks of HIIT, 2x/week for about 30 minutes/session on a cycle ergometer
Continuous Aerobic Training (CAT)Behavioural
8 weeks of CAT, 2x/week for about 50 minutes/session on a cycle ergometer
Movement AdviceBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Physical Training Group 1 (n=16) | Experimental | High Intensity Interval Training Receives: Behavioral: High Intensity Interval Training (HIIT) |
| Physical Training Group 2 (n=16) | Experimental | Continuous Aerobic Training Receives: Behavioral: Continuous Aerobic Training (CAT) |
| Physical Training Group 3 (n=16) | Experimental | Movement Advice Receives: Behavioral: Movement Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety and depressive symptoms
The effect of physical training on anxiety and depressive symptoms, measured by the Hospital Anxiety and Depression Scale
Measured: Baseline (week 0), week 4, week 12, week 16
Secondary outcomes (24)
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)
Measured: Baseline (week 0), week 4, week 12, week 16
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
Measured: Baseline (week 0), week 4, week 12, week 16
Change in cognitive function (i.e., mental flexibility)
The effect of physical training on cognitive function, measured by the Trail Making Test
Measured: 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)
The effect of physical training on cognitive function, measured by the Symbol Digit Modalities Test
Measured: Baseline (week 0), week 4, week 12, week 16
Change in fatigue
The effect of physical training on fatigue, measured by the Checklist Individual Strength fatigue sub-scale
Measured: Baseline (week 0), week 4, week 12, week 16
Change in sleep quality
The effect of physical training on sleep quality, measured by the Insomnia Severity Index
Measured: Baseline (week 0), week 4, week 12, week 16
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)
Measured: Baseline (week 0), week 4, week 12, week 16
Change in quality of life
The effect of physical training on quality of life, measured by the Short Form health survey (36 items)
Measured: Baseline (week 0), week 4, week 12, week 16
Change in motor capacity (i.e., walking speed)
The effect of physical training on motor capacity, measured by the 10-Meter Walk Test
Measured: Baseline (week 0), week 4, week 12, week 16
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
Measured: Baseline (week 0), week 4, week 12, week 16
Change in motor capacity (i.e., finger dexterity)
The effect of physical training on motor capacity, measured by the Nine Hole Peg Test
Measured: Baseline (week 0), week 4, week 12, week 16
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
Measured: Baseline (week 0), week 4, week 12, week 16
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
Measured: Baseline (week 0), week 4, week 12, week 16
Change in biomarkers of neurodegeneration in blood
The effect of physical training on biomarkers of neurodegeneration in blood, measured by Neurofilament Light concentration
Measured: Baseline (week 0), week 4, week 12, week 16
Change in brain morphology
The effect of physical training on brain morphology, measured by structural magnetic resonance imaging (MRI)
Measured: Week 4, week 12
Change in structural brain connectivity
The effect of physical training on structural brain connectivity, measured by diffusion MRI + free-water content
Measured: Week 4, week 12
Change in brain connectivity
The effect of physical training on brain connectivity, measured by resting state functional MRI
Measured: Week 4, week 12
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
Measured: Week 4, week 12
Change in brain neuromelanin content
The effect of physical training on brain neuromelanin content, measured by neuromelanin-sensitive MRI
Measured: Week 4, week 12
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)
Measured: Weekly assessment from baseline to week 16
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)
Measured: Weekly assessment from baseline to week 16
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)
Measured: Weekly assessment from baseline to week 16
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)
Measured: Weekly assessment from baseline to week 16
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)
Measured: Weekly assessment from baseline to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start2 May 2022
- Primary completion2 May 2025 (estimated)
- Study completion2 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Brain Foundation
- Responsible party
- Principal investigator, Dr. Erwin E. H. van Wegen, Amsterdam UMC, location VUmc
- Investigators
- Erwin EH van Wegen, Dr., Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357638
- Sponsor's protocol ID
- NL78096.029.21
- Acronym
- HersenFIT
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2022
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Training for People With Parkinson's Disease and Multiple Sclerosis: Effect on Mind and Body
- ClinicalTrials.gov ID
- NCT05357638
- Acronym / sponsor ID
- HersenFIT / NL78096.029.21
- Conditions
- Parkinson Disease, Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Netherlands Brain Foundation
- Study start
- 2 May 2022 (actual)
- Primary completion
- 2 May 2025 (estimated)
- Study completion
- 2 Nov 2025 (estimated)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical Training Group 1 (n=16) | Experimental | Behavioral: High Intensity Interval Training (HIIT)High Intensity Interval Training |
| Physical Training Group 2 (n=16) | Experimental | Behavioral: Continuous Aerobic Training (CAT)Continuous Aerobic Training |
| Physical Training Group 3 (n=16) | Experimental | Behavioral: Movement AdviceMovement Advice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Interval Training (HIIT)8 weeks of HIIT, 2x/week for about 30 minutes/session on a cycle ergometer | Behavioural | Physical Training Group 1 (n=16) |
| Continuous Aerobic Training (CAT)8 weeks of CAT, 2x/week for about 50 minutes/session on a cycle ergometer | Behavioural | Physical Training Group 2 (n=16) |
| Movement AdviceWeekly 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 | Behavioural | Physical Training Group 3 (n=16) |
Primary outcome
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
24 secondary outcomes
Change in disease severity
Time frame: 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
Change in cognitive function (i.e., mental flexibility)
Time frame: 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
Change in fatigue
Time frame: Baseline (week 0), week 4, week 12, week 16
Change in sleep quality
Time frame: Baseline (week 0), week 4, week 12, week 16
Change in well-being
Time frame: 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
Change in motor capacity (i.e., walking speed)
Time frame: 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
Change in motor capacity (i.e., finger dexterity)
Time frame: 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
Change in biomarkers of neuroplasticity in blood
Time frame: 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
Change in brain morphology
Time frame: Week 4, week 12
Change in structural brain connectivity
Time frame: Week 4, week 12
Change in brain connectivity
Time frame: Week 4, week 12
Change in brain iron concentration in the Substantia Nigra
Time frame: Week 4, week 12
Change in brain neuromelanin content
Time frame: Week 4, week 12
Change in daily mood
Time frame: Weekly assessment from baseline to week 16
Change in daily anxiety
Time frame: Weekly assessment from baseline to week 16
Change in daily ability to concentrate
Time frame: Weekly assessment from baseline to week 16
Change in daily fatigue
Time frame: Weekly assessment from baseline to week 16
Change in daily sleep quality
Time frame: Weekly assessment from baseline to week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Website of the trialLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erwin EH van Wegen, Dr. principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training (HIIT), Continuous Aerobic Training (CAT) and Movement Advice in people with Parkinson Disease and Multiple Sclerosis, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erwin EH van Wegen, Dr. (020-4440461, e.vanwegen@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety and depressive symptoms (time frame: Baseline (week 0), week 4, week 12, week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.