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| ID | Type | Description | Link |
|---|---|---|---|
| p-2025-18530 | Other Identifier | Capital Region of Denmark |
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| Name | Class |
|---|---|
| Copenhagen Trial Unit, Center for Clinical Intervention Research | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | 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. |
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| Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motor-cognitive exercise | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: 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. | 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. | From enrollment to 1-year follow-up (T4) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to 6-month follow-up (T3) |
| Feasibility: Missing data (secondary clinical outcomes) |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory secondary clinical outcomes | Hospital and institution free days | Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year. |
| Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annemette Løkkegaard, MD, PhD | Contact | +45 38 63 52 48 | annemette.loekkegaard@regionh.dk | |
| Løkkegaard | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, Bispebjerg and Frederiksberg Hospital | Recruiting | Copenhagen NV | 2400 | Denmark |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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.
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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.
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| Usual Care | Other | Best medical treatment: usual management of participants' PD and other potential comorbidities at the discretion of their regular physician and other health providers. |
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Proportion of missing data on the exploratory secondary clinical outcomes. A proportion of less than 10% will be considered acceptable. |
| 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. | 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. | Through study completion, an average of 1 year |
| Feasibility: Treatment fidelity | Examination of attendance rate | Through study completion, an average of 1 year |
| Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year. |
| Montreal Cognitive Assessment (MoCA) | Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year. |
| Short Falls Efficacy Scale (Short-FES) | Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year. |
| Parkinson's Disease Questionnaire (PDQ-39) | Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year. |
| Mini Balance Evaluation Systems Test (Mini-BESTest) | Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year. |
| 30-second Chair Stand Test (30s-CST) | Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year |
| Handgrip strength (HGS) | Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year. |
| Timed Up and Go (TUG) | Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year. |
| Physical activity, Diary | Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year. |
| Falls, diary | Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year. |
| Dual-task interference (DTi) | Through study completion, an average of 1 year. The following time-points: Baseline, end of intervention at 12 weeks, follow-up at 6 months and follow-up at 1 year. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |