Parkinson Disease (PD)Ex-ParkNCT07465107
Motor and Cognitive Exercise in Parkinson's Disease.
A study testing Motor-cognitive exercise in people with Parkinson Disease (PD), run by Annemette Lokkegaard at 1 site in Denmark.
Trial summary
The aim of this study is to examine the effects of a specialized multi-modal intervention in patients with moderate to advanced Parkinson's disease (PD). The hypothesis is that a specialized motor- and cognitive exercise program in addition to usual care can improve gait and balance better than usual care alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease (PD)
- What is being tested?
- Motor-cognitive exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Mar 2025to 14 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 PD according to MDS-PD criteria
- Aged ≥ 18 years
- Informed consent
- PD symptoms ≥ 4 years
- Independent gait
Who cannot join
- Diagnosis of PD Dementia according to the MDS-PD Dementia criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Løkkegaard contact
Denmark1 site, 1 recruiting
- Recruiting
Department of Neurology, Bispebjerg and Frederiksberg Hospital
Copenhagen NV, 2400
Annemette Løkkegaard, MD, PhD, +45 38 63 52 48, annemette.loekkegaard@regionh.dk
About this study
Official title: Motor and Cognitive Exercise in Parkinson's Disease. A Feasibility Randomized Clinical Trial
The aim of this study is to examine the effects of a specialized multi-modal intervention in patients with moderate to advanced Parkinson's disease (PD). The hypothesis is that a specialized motor- and cognitive exercise program in addition to usual care can improve gait and balance better than usual care alone.
48 patients with PD and a symptom duration of 4 or more years will be randomized 1:1 to either a control arm or to an intervention arm. The control arm will have usual management of their PD. The intervention arm will receive exercises aimed at both motor and cognitive impairments of PD over the course of 12 weeks.
Read more
The study has been designed in partnership with the Copenhagen Trial Unit (CTU), Copenhagen Univeristy Hospital, to ensure both internal and external validity. To increase reproducibility, detailed protocols for all training modalities will be shared along with the study results.
This study is a feasibility study with the intention of a following international multi-center study to corroborate the results. Both feasibility outcomes for the intervention itself and clinical outcomes for the participants will be published.
Read the detailed description
Intervention: The exercise program will consist of gait and balance training, lower body strength training and dual task training while treadmill walking. The program will include an individualized and progressive exercise program 3 times x 1 hour a week for 12 weeks with the following exercise modalities:
- Treadmill training for gait and balance training combined with dual task motor cognitive training.
- Progressive gait and motor-cognitive balance exercises
- Progressive resistance training including leg press.
The program will be conducted under supervision by a physiotherapist or an exercise physiologist. Usual treatment is permitted during the trial, both pharmacological and non-pharmacological. The treatment is preferably stable during the intervention and follow-up, but necessary changes will be registered.
All participants will be examined at baseline, after 12 weeks and again 6 and 12 months after baseline.
- Conditions
- Parkinson Disease (PD)
- Being tested
- Motor-cognitive exercise, Usual Care
- Keywords
- Parkinson Disease, Exercise Therapy, Gait, Balance, Motor-cognitive training, Dual-task, Neurological Rehabilitation, Psychomotor Performance
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor-cognitive exerciseOther
3 weekly 1-hour sessions of motor-cognitive exercise. Each 1-hour session will be multi-modal with 20 minutes of dynamic balance training, 20 minutes of dual-task exercises while treadmill walking and 20 minutes of lower body strength training with leg press. Detailed protocols for the exercises will be published along with results.
Usual CareOther
Best medical treatment: usual management of participants' PD and other potential comorbidities at the discretion of their regular physician and other health providers.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The control arm will continue usual management (best medical treatment) of their PD and other potentiel comorbidities at the discretion of their regular physician and other health providers. Enrollment in this study will not influence any clinical decisions or potential changes in management. Receives: Other: Usual Care |
| Intervention | Experimental | The intervention arm will receive 3 weekly 1-hour sessions of multi-modal training over the course of 12 weeks, totaling 36 sessions, in addition to usual management (best medical treatment). As with the control arm, any clinical decisions or potential changes in management will not be influenced be enrollment in this study. Receives: Other: Motor-cognitive exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Intervention adherence
Adherence defined as the proportion of participation in exercise sessions out of 36. A proportion of more than 60% will be considered acceptable.
Measured: From allocation to the end of 12 weeks of intervention (T2)
Exploratory composite clinical outcome: Significant fall, all-cause hospitalization and all-cause mortality
A composite outcome of either death, unplanned hospitalization or a significant fall. A significant fall will be defined as a fall leading to an unplanned hospital contact or contact with the general practitioner.
This composite outcome is based on binary events that will be registered at each pre-specified follow-up time.
Measured: From enrollment to 1-year follow-up (T4)
Secondary outcomes (5)
Feasibility: Missing data (primary clinical outcome)
Proportion of missing data on the exploratory primary clinical outcome "Significant fall, all-cause hospitalization and all-cause mortality". A proportion of less than 5% will be considered acceptable.
Measured: From enrollment to 6-month follow-up (T3)
Feasibility: Missing data (secondary clinical outcomes)
Proportion of missing data on the exploratory secondary clinical outcomes. A proportion of less than 10% will be considered acceptable.
Measured: At baseline (T1), end of intervention at 12 weeks (T2), follow-up at 6 months (T3) and follow-up at 1 year (T4).
Feasibility: Randomization rate
Screened compared to randomized. A rate of more than 70% randomized will be considered acceptable.
Measured: From screening to baseline, up to 1 year.
Feasibility: Drop-out rate
Drop-out at any time after enrollment. A drop-out of about 20 % is expected.
Measured: Through study completion, an average of 1 year
Feasibility: Treatment fidelity
Examination of attendance rate
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start26 Mar 2025
- Primary completion14 Feb 2027 (estimated)
- Study completion14 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial with assessor blinded endpoints. Participants will be randomized to one of two study arms, receiving either usual care in the control arm or multi-modal intervention in addition to usual care in the intervention arm. Both study arms will be assessed by blinded personnel at baseline and at the end of the 12 weeks of intervention with follow-up assessments at 6 months and 12 months after baseline. During the intervention period, falls and physical activity in both groups will be registered.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Annemette Lokkegaard
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen Trial Unit, Center for Clinical Intervention Research
- Responsible party
- Sponsor-investigator, Annemette Lokkegaard, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465107
- Sponsor's protocol ID
- H-25001087
- Other IDs
- p-2025-18530
- Acronym
- Ex-Park
- Status last verified
- Mar 2026
- First submitted
- 26 May 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor and Cognitive Exercise in Parkinson's Disease. A Feasibility Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07465107
- Acronym / sponsor ID
- Ex-Park / H-25001087
- Conditions
- Parkinson Disease (PD)
- Keywords
- Parkinson Disease, Exercise Therapy, Gait, Balance, Motor-cognitive training, Dual-task, Neurological Rehabilitation, Psychomotor Performance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Annemette LokkegaardUniversity, hospital or other
- Collaborators
- Copenhagen Trial Unit, Center for Clinical Intervention Research
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 14 Feb 2027 (estimated)
- Study completion
- 14 Feb 2027 (estimated)
- First posted
- 11 Mar 2026 (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 aim of this study is to examine the effects of a specialized multi-modal intervention in patients with moderate to advanced Parkinson's disease (PD). The hypothesis is that a specialized motor- and cognitive exercise program in addition to usual care can improve gait and balance better than usual care alone.
48 patients with PD and a symptom duration of 4 or more years will be randomized 1:1 to either a control arm or to an intervention arm. The control arm will have usual management of their PD. The intervention arm will receive exercises aimed at both motor and cognitive impairments of PD over the course of 12 weeks.
The study has been designed in partnership with the Copenhagen Trial Unit (CTU), Copenhagen Univeristy Hospital, to ensure both internal and external validity. To increase reproducibility, detailed protocols for all training modalities will be shared along with the study results.
This study is a feasibility study with the intention of a following international multi-center study to corroborate the results. Both feasibility outcomes for the intervention itself and clinical outcomes for the participants will be published.
Detailed description
Intervention: The exercise program will consist of gait and balance training, lower body strength training and dual task training while treadmill walking. The program will include an individualized and progressive exercise program 3 times x 1 hour a week for 12 weeks with the following exercise modalities:
- Treadmill training for gait and balance training combined with dual task motor cognitive training.
- Progressive gait and motor-cognitive balance exercises
- Progressive resistance training including leg press.
The program will be conducted under supervision by a physiotherapist or an exercise physiologist. Usual treatment is permitted during the trial, both pharmacological and non-pharmacological. The treatment is preferably stable during the intervention and follow-up, but necessary changes will be registered.
All participants will be examined at baseline, after 12 weeks and again 6 and 12 months after baseline.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial with assessor blinded endpoints. Participants will be randomized to one of two study arms, receiving either usual care in the control arm or multi-modal intervention in addition to usual care in the intervention arm. Both study arms will be assessed by blinded personnel at baseline and at the end of the 12 weeks of intervention with follow-up assessments at 6 months and 12 months after baseline. During the intervention period, falls and physical activity in both groups will be registered.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Usual CareThe control arm will continue usual management (best medical treatment) of their PD and other potentiel comorbidities at the discretion of their regular physician and other health providers. Enrollment in this study will not influence any clinical decisions or potential changes in management. |
| Intervention | Experimental | Other: Motor-cognitive exerciseThe intervention arm will receive 3 weekly 1-hour sessions of multi-modal training over the course of 12 weeks, totaling 36 sessions, in addition to usual management (best medical treatment). As with the control arm, any clinical decisions or potential changes in management will not be influenced be enrollment in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of PD according to MDS-PD criteria
- Aged ≥ 18 years
- Informed consent
- PD symptoms ≥ 4 years
- Independent gait
Key exclusion criteria (1 listed)
- Diagnosis of PD Dementia according to the MDS-PD Dementia criteria
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 |
|---|---|---|
| Motor-cognitive exercise3 weekly 1-hour sessions of motor-cognitive exercise. Each 1-hour session will be multi-modal with 20 minutes of dynamic balance training, 20 minutes of dual-task exercises while treadmill walking and 20 minutes of lower body strength training with leg press. Detailed protocols for the exercises will be published along with results. | Other | Intervention |
| Usual CareBest medical treatment: usual management of participants' PD and other potential comorbidities at the discretion of their regular physician and other health providers. | Other | Control |
Primary outcome
Feasibility: Intervention adherence
Time frame: From allocation to the end of 12 weeks of intervention (T2)
Adherence defined as the proportion of participation in exercise sessions out of 36. A proportion of more than 60% will be considered acceptable.
Exploratory composite clinical outcome: Significant fall, all-cause hospitalization and all-cause mortality
Time frame: From enrollment to 1-year follow-up (T4)
A composite outcome of either death, unplanned hospitalization or a significant fall. A significant fall will be defined as a fall leading to an unplanned hospital contact or contact with the general practitioner. This composite outcome is based on binary events that will be registered at each pre-specified follow-up time.
5 secondary outcomes
Feasibility: Missing data (primary clinical outcome)
Time frame: From enrollment to 6-month follow-up (T3)
Feasibility: Missing data (secondary clinical outcomes)
Time frame: At baseline (T1), end of intervention at 12 weeks (T2), follow-up at 6 months (T3) and follow-up at 1 year (T4).
Feasibility: Randomization rate
Time frame: From screening to baseline, up to 1 year.
Feasibility: Drop-out rate
Time frame: Through study completion, an average of 1 year
Feasibility: Treatment fidelity
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- 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.
Løkkegaard contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor-cognitive exercise in people with Parkinson Disease (PD), run by Annemette Lokkegaard 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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 11 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annemette Løkkegaard, MD, PhD (+45 38 63 52 48, annemette.loekkegaard@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Intervention adherence (time frame: From allocation to the end of 12 weeks of intervention (T2)). The study lists 2 primary outcomes in all. 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 11 Mar 2026.