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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of PD according to MDS-PD criteria

• Aged ≥ 18 years

• Informed consent

• PD symptoms ≥ 4 years

• Independent gait

Locations
Other Locations
Denmark
Department of Neurology, Bispebjerg and Frederiksberg Hospital
RECRUITING
Copenhagen Nv
Contact Information
Primary
Annemette Løkkegaard, MD, PhD
annemette.loekkegaard@regionh.dk
+45 38 63 52 48
Backup
Løkkegaard
Time Frame
Start Date: 2025-03-26
Estimated Completion Date: 2027-02-14
Participants
Target number of participants: 48
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: Copenhagen Trial Unit, Center for Clinical Intervention Research
Leads: Annemette Lokkegaard

This content was sourced from clinicaltrials.gov

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