Motor and Cognitive Exercise in Parkinson's Disease. (Ex-Park)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease (PD)
• Intervention / Treatment: Other: Usual Care; Other: Motor-cognitive exercise

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:

1. Treadmill training for gait and balance training combined with dual task motor cognitive training.
2. Progressive gait and motor-cognitive balance exercises
3. 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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annemette Løkkegaard, MD, PhD; Phone Number: +45 38 63 52 48; Email: annemette.loekkegaard@regionh.dk
• Study Contact Backup: Name: Løkkegaard

Study Locations

• Denmark
  • Copenhagen NV, Denmark, 2400
    • Recruiting
    • Department of Neurology, Bispebjerg and Frederiksberg Hospital
    • Contact: Annemette Løkkegaard, MD, PhD; Phone Number: +45 38 63 52 48; Email: annemette.loekkegaard@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; 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.	Other: Usual Care; Best medical treatment: usual management of participants' PD and other potential comorbidities at the discretion of their regular physician and other health providers.
Experimental: Intervention; 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.	Other: Motor-cognitive exercise; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From enrollment to 1-year follow-up (T4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Through study completion, an average of 1 year
Feasibility: Treatment fidelity	Examination of attendance rate	Through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory secondary clinical outcomes	Hospital and institution free days	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.
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)		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.
Montreal Cognitive Assessment (MoCA)		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.
Short Falls Efficacy Scale (Short-FES)		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.
Parkinson's Disease Questionnaire (PDQ-39)		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.
Mini Balance Evaluation Systems Test (Mini-BESTest)		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.
30-second Chair Stand Test (30s-CST)		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
Handgrip strength (HGS)		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.
Timed Up and Go (TUG)		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.
Physical activity, Diary		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.
Falls, diary		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.
Dual-task interference (DTi)		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.

Collaborators and Investigators

• Sponsor: Annemette Lokkegaard
• Collaborators: Copenhagen Trial Unit, Center for Clinical Intervention Research

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2025
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): February 14, 2027

Study Registration Dates

• First Submitted: May 26, 2025
• First Submitted That Met QC Criteria: March 6, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Balance; Gait; Parkinson Disease; Dual-task; Exercise Therapy; Neurological Rehabilitation; Psychomotor Performance; Motor-cognitive training
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: H-25001087; p-2025-18530 (Other Identifier: Capital Region of Denmark)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No