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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
48
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.
Best medical treatment: usual management of participants' PD and other potential comorbidities at the discretion of their regular physician and other health providers.
Department of Neurology, Bispebjerg and Frederiksberg Hospital
Copenhagen NV, Denmark
RECRUITINGFeasibility: 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.
Time frame: 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.
Time frame: From enrollment to 1-year follow-up (T4)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 1 year
Feasibility: Treatment fidelity
Examination of attendance rate
Time frame: Through study completion, an average of 1 year
Løkkegaard
CONTACT
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