Parkinson DiseaseNCT04379778
Aerobic Exercise and Brain Health in Parkinson's
A study testing Aerobic exercise in people with Parkinson Disease, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of the project is to investigate how moderate to high intensity aerobic exercise affects brain health in patients with Parkinson's disease. Assessments include MRI, blood markers, cognition, functional tests, questionnaires, and cardiorespiratory fitness. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2021to 1 Oct 2023
- 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 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Age ≥ 40 years
- Idiopathic PD diagnosis (within the previous five years)
- Patients in symptomatic therapy / not in therapy. Patients who are not already taking medication are not expected to need medication within 6 months of inclusion (in case of drug startup, this is noted)
- Hoehn \& Yahr ≤ 3
- Ability to transport oneself to and from exercise and testing
Who cannot join
- Alcohol abuse, depression, pacemaker
- Comorbidity/competing (neurological) disorder preventing participation in the intervention
- Pregnancy
- Metallic implants that prevent MRI.
- Expected exercise adherence below 85% of all planned sessions.
- Systematic moderate-high-level AE more than twice per week prior to start-up in the project
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Sport Science, Department of Public Health, Aarhus University
Aarhus, Aarhus C, 8000
About this study
Official title: Effects of Aerobic Exercise on Brain Health in Parkinson's Disease
The purpose of the project is to investigate how moderate to high intensity aerobic exercise affects brain health in patients with Parkinson's disease. Assessments include MRI, blood markers, cognition, functional tests, questionnaires, and cardiorespiratory fitness.
The study will be a single blinded randomized controlled trial with a 6-month long intervention.
Read the detailed description
Background: No approved medical treatments preventing, delaying or stopping Parkinson's disease (PD) exist, making identification of interventions having this potential a major priority. Exercise studies have demonstrated beneficial effects of aerobic exercise (AE) on aerobic capacity, cognition, depression and the Unified Parkinson's Disease Rating Scale (UPDRS). Animal studies show that AE can reduce α-synuclein aggregation and toxin-induced lesions in the nigrostriatal pathway while improving motor and cognitive function. Consequently, AE possesses neuroprotective potentials and thus represents a potentially inexpensive and easily accessible disease modifying therapy in PD. Evolving magnetic resonance imaging (MRI) techniques offer valid and reliable biomarkers to monitor disease progression, but no longitudinal MRI study has assessed the neuroprotective potentials of AE in PD.
Aim: To investigate whether 24 weeks of AE can delay PD progression markers and improve motor/non-motor symptoms in PD.
Methods: 70 PD patients will be randomized 1:1 to 24 weeks of supervised AE (60 sessions, moderate to high intensity) or standard care. Neuroprotective effects will be determined by MRI scans (R2*, quantitative susceptibility mapping, diffusion kurtosis imaging, neuromelanin-weighted MRI, volumetry), blood markers and Levodopa equivalents. Clinical (MDS-UPDRS III) and subjective (MDS-UPDRS I) outcomes are also assessed.
Perspectives: By combining expertise from exercise physiology, radiology, endocrinology and neuropsychology a novel approach is taken aiming to understand the possible neuroprotective effects of AE in PD. This would be of high relevance to PD patients and their relatives. From a societal perspective it may lower disability-related costs by optimizing PD rehabilitation. In case of positive findings, this would provide the first convincing human evidence of a disease modifying effect of AE in PD potentially changing clinical practice.
- Conditions
- Parkinson Disease
- Being tested
- Aerobic exercise
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
Progressive moderate to high intensity aerobic exercise.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Experimental | Moderate to high intensity aerobic exercise for 24 weeks. Receives: Other: Aerobic exercise |
| Standard care | No intervention | Habitual lifestyle including standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
R2* MRI change
Effective transverse relaxation rate (R2*)
Measured: 0, 24 and 48 weeks
Secondary outcomes (15)
QSM MRI change
Measured: 0, 24 and 48 weeks
DKI MRI change
Measured: 0, 24 and 48 weeks
Neuromelanin MRI change
Measured: 0, 24 and 48 weeks
Volumetry MRI change
Measured: 0, 24 and 48 weeks
Change in blood markers (e.g. α-synuclein)
Measured: 0, 24 and 48 weeks
Change in Levodopa equivalents
Measured: 0, 24 and 48 weeks
MDS-UPDRS change
Measured: 0, 24 and 48 weeks
Aerobic capacity (VO2max test)
Measured: 0, 24 and 48 weeks
Timed up and go (TUG) change
Measured: 0, 24 and 48 weeks
6 min walk test (6MWT) change
Measured: 0, 24 and 48 weeks
Balance (Mini BESTest) change
Measured: 0, 24 and 48 weeks
Cognition (The Montreal Cognitive Assessment (MoCA)) change
Measured: 0, 24 and 48 weeks
Health-related quality of life (Parkinson's Disease Questionnaire (PDQ-39)) change
Measured: 0, 24 and 48 weeks
Depression (Beck Depression Inventory-II (BDI-II)) change
Measured: 0, 24 and 48 weeks
Non-motor symptoms (Non-Motor Symptoms Questionnaire (NMSQ)) change
Measured: 0, 24 and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start1 Mar 2021
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Langeskov-Christensen, Ph.d., Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379778
- Sponsor's protocol ID
- Brain Health in Parkinson's
- Status last verified
- Nov 2022
- First submitted
- 29 Apr 2020
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Langeskov-Christensen M, Nygaard MKE, Eskildsen SF, Ringgaard S, Geday J, Danielsen EH, Johnsen EL, Thrue C, Bonde-Jensen F, Hvid LG, Dalgas U. Efficacy of Aerobic Exercise on Brain MRI Measures in Parkinson's Disease. Neurorehabil Neural Repair. 2026 May 22:15459683261448458. doi: 10.1177/15459683261448458. Online ahead of print.
PubMed 42170720Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Exercise on Brain Health in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04379778
- Acronym / sponsor ID
- Brain Health in Parkinson's
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 7 May 2020 (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.
The purpose of the project is to investigate how moderate to high intensity aerobic exercise affects brain health in patients with Parkinson's disease. Assessments include MRI, blood markers, cognition, functional tests, questionnaires, and cardiorespiratory fitness.
The study will be a single blinded randomized controlled trial with a 6-month long intervention.
Detailed description
Background: No approved medical treatments preventing, delaying or stopping Parkinson's disease (PD) exist, making identification of interventions having this potential a major priority. Exercise studies have demonstrated beneficial effects of aerobic exercise (AE) on aerobic capacity, cognition, depression and the Unified Parkinson's Disease Rating Scale (UPDRS). Animal studies show that AE can reduce α-synuclein aggregation and toxin-induced lesions in the nigrostriatal pathway while improving motor and cognitive function. Consequently, AE possesses neuroprotective potentials and thus represents a potentially inexpensive and easily accessible disease modifying therapy in PD. Evolving magnetic resonance imaging (MRI) techniques offer valid and reliable biomarkers to monitor disease progression, but no longitudinal MRI study has assessed the neuroprotective potentials of AE in PD.
Aim: To investigate whether 24 weeks of AE can delay PD progression markers and improve motor/non-motor symptoms in PD.
Methods: 70 PD patients will be randomized 1:1 to 24 weeks of supervised AE (60 sessions, moderate to high intensity) or standard care. Neuroprotective effects will be determined by MRI scans (R2*, quantitative susceptibility mapping, diffusion kurtosis imaging, neuromelanin-weighted MRI, volumetry), blood markers and Levodopa equivalents. Clinical (MDS-UPDRS III) and subjective (MDS-UPDRS I) outcomes are also assessed.
Perspectives: By combining expertise from exercise physiology, radiology, endocrinology and neuropsychology a novel approach is taken aiming to understand the possible neuroprotective effects of AE in PD. This would be of high relevance to PD patients and their relatives. From a societal perspective it may lower disability-related costs by optimizing PD rehabilitation. In case of positive findings, this would provide the first convincing human evidence of a disease modifying effect of AE in PD potentially changing clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Other: Aerobic exerciseModerate to high intensity aerobic exercise for 24 weeks. |
| Standard care | No intervention | –Habitual lifestyle including standard care. |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent
- Age ≥ 40 years
- Idiopathic PD diagnosis (within the previous five years)
- Patients in symptomatic therapy / not in therapy. Patients who are not already taking medication are not expected to need medication within 6 months of inclusion (in case of drug startup, this is noted)
- Hoehn \& Yahr ≤ 3
Key exclusion criteria (6 listed)
- Alcohol abuse, depression, pacemaker
- Comorbidity/competing (neurological) disorder preventing participation in the intervention
- Pregnancy
- Metallic implants that prevent MRI.
- Expected exercise adherence below 85% of all planned sessions.
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 |
|---|---|---|
| Aerobic exerciseProgressive moderate to high intensity aerobic exercise. | Other | Aerobic exercise |
Primary outcome
R2* MRI change
Time frame: 0, 24 and 48 weeks
Effective transverse relaxation rate (R2*)
15 secondary outcomes
QSM MRI change
Time frame: 0, 24 and 48 weeks
DKI MRI change
Time frame: 0, 24 and 48 weeks
Neuromelanin MRI change
Time frame: 0, 24 and 48 weeks
Volumetry MRI change
Time frame: 0, 24 and 48 weeks
Change in blood markers (e.g. α-synuclein)
Time frame: 0, 24 and 48 weeks
Change in Levodopa equivalents
Time frame: 0, 24 and 48 weeks
MDS-UPDRS change
Time frame: 0, 24 and 48 weeks
Aerobic capacity (VO2max test)
Time frame: 0, 24 and 48 weeks
Timed up and go (TUG) change
Time frame: 0, 24 and 48 weeks
6 min walk test (6MWT) change
Time frame: 0, 24 and 48 weeks
Balance (Mini BESTest) change
Time frame: 0, 24 and 48 weeks
Cognition (The Montreal Cognitive Assessment (MoCA)) change
Time frame: 0, 24 and 48 weeks
Health-related quality of life (Parkinson's Disease Questionnaire (PDQ-39)) change
Time frame: 0, 24 and 48 weeks
Depression (Beck Depression Inventory-II (BDI-II)) change
Time frame: 0, 24 and 48 weeks
Non-motor symptoms (Non-Motor Symptoms Questionnaire (NMSQ)) change
Time frame: 0, 24 and 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 42170720Langeskov-Christensen M, Nygaard MKE, Eskildsen SF, Ringgaard S, Geday J, Danielsen EH, Johnsen EL, Thrue C, Bonde-Jensen F, Hvid LG, Dalgas U. Efficacy of Aerobic Exercise on Brain MRI Measures in Parkinson's Disease. Neurorehabil Neural Repair. 2026 May 22:15459683261448458. doi: 10.1177/15459683261448458. Online ahead of print.
- Derived from this study: PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
- Derived from this study: PubMed 36602886Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
- Individual participant dataSharing planned: No
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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.
Martin Langeskov-Christensen, Ph.d. principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Parkinson Disease, run by University of Aarhus at 1 site in Denmark.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 8 May 2024. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R2* MRI change (time frame: 0, 24 and 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04379778, which also lists 3 linked publications.
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 8 May 2024.