Parkinson Disease (PD)
Conditions
Keywords
Parkinson Disease, Exercise Therapy, Gait, Balance, Motor-cognitive training, Dual-task, Neurological Rehabilitation, Psychomotor Performance
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.
Detailed description
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.
Interventions
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.
OTHERUsual Care
Best medical treatment: usual management of participants' PD and other potential comorbidities at the discretion of their regular physician and other health providers.
Sponsors
Annemette Lokkegaard
Copenhagen Trial Unit, Center for Clinical Intervention Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Intervention adherence | From allocation to the end of 12 weeks of intervention (T2) | Adherence defined as the proportion of participation in exercise sessions out of 36. A proportion of more than 60% will be considered acceptable. |
| Exploratory composite clinical outcome: Significant fall, all-cause hospitalization and all-cause mortality | From enrollment to 1-year follow-up (T4) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Missing data (primary clinical outcome) | From enrollment to 6-month follow-up (T3) | 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. |
| 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). | Proportion of missing data on the exploratory secondary clinical outcomes. A proportion of less than 10% will be considered acceptable. |
| Feasibility: Randomization rate | From screening to baseline, up to 1 year. | Screened compared to randomized. A rate of more than 70% randomized will be considered acceptable. |
| Feasibility: Drop-out rate | Through study completion, an average of 1 year | Drop-out at any time after enrollment. A drop-out of about 20 % is expected. |
| Feasibility: Treatment fidelity | Through study completion, an average of 1 year | Examination of attendance rate |
Countries
Denmark
Contacts
CONTACTAnnemette Løkkegaard, MD, PhD
CONTACTLøkkegaard
Outcome results
None listed