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NCT Number: NCT07465107

Motor and Cognitive Exercise in Parkinson's Disease.

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.

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Key information

Conditions

Parkinson Disease (PD) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, Bispebjerg and Frederiksberg Hospital

Copenhagen NV, 2400, Denmark

Location status: Recruiting

Location contact

Annemette Løkkegaard, MD, PhD

CONTACT

[email protected]

+45 38 63 52 48

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of PD according to MDS-PD criteria
  • Aged ≥ 18 years
  • Informed consent
  • PD symptoms ≥ 4 years
  • Independent gait

Exclusion criteria

  • Diagnosis of PD Dementia according to the MDS-PD Dementia criteria

Treatment and study plan

Motor-cognitive exercise

Other

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 Care

Other

Best medical treatment: usual management of participants' PD and other potential comorbidities at the discretion of their regular physician and other health providers.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Feasibility: Missing data (primary clinical outcome)

    Time frame: From enrollment to 6-month follow-up (T3)

    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.

  2. 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).

    Proportion of missing data on the exploratory secondary clinical outcomes. A proportion of less than 10% will be considered acceptable.

  3. Feasibility: Randomization rate

    Time frame: From screening to baseline, up to 1 year.

    Screened compared to randomized. A rate of more than 70% randomized will be considered acceptable.

  4. Feasibility: Drop-out rate

    Time frame: Through study completion, an average of 1 year

    Drop-out at any time after enrollment. A drop-out of about 20 % is expected.

  5. Feasibility: Treatment fidelity

    Time frame: Through study completion, an average of 1 year

    Examination of attendance rate

Other outcomes

  1. Exploratory secondary clinical outcomes

    Time frame: Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year.

    Hospital and institution free days

  2. Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    Time frame: Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year.

  3. Montreal Cognitive Assessment (MoCA)

    Time frame: Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year.

  4. Short Falls Efficacy Scale (Short-FES)

    Time frame: Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year.

  5. Parkinson's Disease Questionnaire (PDQ-39)

    Time frame: Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year.

  6. Mini Balance Evaluation Systems Test (Mini-BESTest)

    Time frame: Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year.

  7. 30-second Chair Stand Test (30s-CST)

    Time frame: Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year

  8. Handgrip strength (HGS)

    Time frame: Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year.

  9. Timed Up and Go (TUG)

    Time frame: Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year.

  10. Physical activity, Diary

    Time frame: Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year.

  11. Falls, diary

    Time frame: Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year.

  12. Dual-task interference (DTi)

    Time frame: Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year.

Study contacts

Contact information is provided by the study sponsor or research team.

Annemette Løkkegaard, MD, PhD

CONTACT

[email protected]

+45 38 63 52 48

Løkkegaard

CONTACT

Sponsors and collaborators

Lead sponsor

Annemette Lokkegaard

Other

Collaborators

  • Copenhagen Trial Unit, Center for Clinical Intervention Research

Registry information

Official study title

Motor and Cognitive Exercise in Parkinson's Disease. A Feasibility Randomized Clinical Trial

Acronym: Ex-Park

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 11, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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