Motor and Cognitive Exercise in Parkinson's Disease.
Recruiting · NCT07465107 · Interventional (participants receive a specific treatment) · Lead sponsor: Annemette Lokkegaard
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- Department of Neurology, Bispebjerg and Frederiksberg Hospital - Copenhagen NV, Denmark