Motor and Cognitive Exercise in Parkinson's Disease.

NCT07465107 | Recruiting DMC

• 2 other identifiers: H-25001087p-2025-18530
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Parkinson Disease (PD)

Keywords

Parkinson Disease; Exercise Therapy; Gait; Balance; Motor-cognitive training; Dual-task; Neurological Rehabilitation; Psychomotor Performance

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Feasibility: Missing data (primary clinical outcome)

  From enrollment to 6-month follow-up (T3)

• Feasibility: Missing data (secondary clinical outcomes)

  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

  From screening to baseline, up to 1 year.

• Feasibility: Drop-out rate

  Through study completion, an average of 1 year

• Feasibility: Treatment fidelity

  Through study completion, an average of 1 year

Other Outcomes (12)

• Exploratory secondary clinical outcomes

  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.

Study Arms (2)

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.

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.

Other: Motor-cognitive exercise

Interventions

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.

Intervention

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Annemette Lokkegaard: lead
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator

Study Sites (1)

Department of Neurology, Bispebjerg and Frederiksberg Hospital

Copenhagen NV, 2400, Denmark

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Annemette Løkkegaard, MD, PhD

CONTACT

+45 38 63 52 48; annemette.loekkegaard@regionh.dk

Løkkegaard

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Health personnel blinded to the allocation status will perform outcome-assessment at baseline and follow-up timepoints. The participants will be asked to conceal their allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, Ass. Professor, Consultant Neurologist

Model Details: 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.

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: March 11, 2026
• Study Start: March 26, 2025
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): February 14, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)