Motor and Cognitive Exercise in Parkinson's Disease.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnnemette Lokkegaard

About this 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.

Eligibility criteria

Qualifiers

Diagnosis of PD according to MDS-PD criteria

Aged ≥ 18 years

Informed consent

PD symptoms ≥ 4 years

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Motor-cognitive exercise
  • Usual Care

Treatment groups

48 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Department of Neurology, Bispebjerg and Frederiksberg HospitalRecruiting2400, Copenhagen NVDenmarkDenmark

Sponsors and collaborators

Annemette Lokkegaard

Lead sponsor

University Hospital Bispebjerg and Frederiksberg

Sponsor institution

Copenhagen Trial Unit, Center for Clinical Intervention Research

Collaborator