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| Name | Class |
|---|---|
| University of Kiel | OTHER |
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The study will evaluate the impact of exercise training program followed by long-walking onon supervised and unsupervised gait assessment in Parkinson´s disease and control subjects.
Background: Several studies suggest an impact of physical exercise on walking parameters in Parkinson´s disease (PD) patients.
Objective: the present study will evaluate the impact of three months physical exercise training program followed by a group-long walking on motor impairment in PD.
Methods:
PD patients will be randomized in two arms: one group will be assessed to a training exercise program of three months followed by long-walking in group under the support of physician/physiotherapist and caregivers. A complete motor, cognitive and general assessment will be performed at baseline. The patients will be evaluated under supervised an unsupervised conditions at baseline, before the long-walking, during the walking and after 2 months after the walk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical exercise program and Long-walking | Experimental | A physical training will be started three months before the long-walking. The subjects will have to walk for at least 3 hours per week up to 6 hours per week during the training. THe long-distance capacity will be verified in 3 different one-day walking of 10, 15 and 18 Km before the long-walking performance. The long-walking will be organized with the support of a physician, study nurse, physiotherapy with car support in case of need. The subject are request to complete the walk of 104 Km of Portuguese route of Santiago de Compostela walk. |
|
| Usual care | No Intervention | The subjects will be followed according to current standard. | |
| Control group-intervention | Active Comparator | A physical training will be started three months before the long-walking. The subjects will have to walk for at least 3 hours per week up to 6 hours per week during the training. THe long-distance capacity will be verified in 3 different one-day walking of 10, 15 and 18 Km before the long-walking performance. The long-walking will be organized with the support of a physician, study nurse, physiotherapy with car support in case of need. The subject are request to complete the walk of 104 Km of Portuguese route of Santiago de Compostela walk. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise program followed by long walk in group | Other | The subjects will be included in a training exercise program for three months followed by a long-walk in group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Supervised gait performance normal gait | Step variability using wearing sensors technology in one-minute supervised walking (rehagait, Hasomed as wearing sensors) | Changes between baseline, immediately before the long-walking, during the day 1 and day 5 of walk and two months after walk In the non-active group- supervised and unsupervised assessment will be evaluated after 6 months of usual care. |
| unsupervised gait performance normal gait | Step variability using wearing sensors technology in one-day unsupervised walking (GaitUp Physilog sensors) | Changes between baseline, immediately before the long-walking, during the day 1 and day 5 of walk and two months after walk. In the non-active group- supervised and unsupervised assessment will be evaluated after 6 months of usual care. |
| Supervised gait performance dual task gait | Step variability using wearing sensors technology in one-minute supervised dual task walking (Rehagait Hasomed as wearing sensors) | Changes between baseline, immediately before the long-walking, during the day 1 and day 5 of walk and two months after walk. In the non-active group- supervised and unsupervised assessment will be evaluated after 6 months of usual care. |
| Measure | Description | Time Frame |
|---|---|---|
| Parkinson´s disease Quality of life questionnaire (PDQ-39) (0-117 points) Lower scores mean worse outcomes | PDQ-39 will be assessed in patients | Changes between baseline, immediately before the long-walking, during the day 1 and day 5 of walk and two months after walk. In the non-active group- the assessment will be evaluated at baseline and after 6 months of usual care. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alessandro Padovani | Università degli Studi di Brescia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology ASST Spedali Civili Brescia | Brescia | Lombardy | 25123 | Italy |
Wearing sensor will be available after completion of the trial
After the completion fo the trial this will be presented in a publication
upon reasonable request
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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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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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A group of Parkinson´s disease Patientserform physical acitivy training for three months followed by long-walking while a parallel group of PD patients will not be included in the training.
A group of age-matched controls will be included in the training protocol as well. matched with
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The clinician and outcome assessors at the beginning and after the training/no intervention will not have access to the assigned arm
| Exercise program followed by long walk in group (controls) | Other | The controls matched for age will perform the same exercise program and long walk as the PD subjects |
|
| Unified parkinson´s disease Rating Scale part 3 (0-132 points) Higher scores mean worse outcomes | Total Movement Disorder Society-Unified Parkinson's disease Rating Scale part 3 motor score | Changes between baseline, immediately before the long-walking, during the day 1 and day 5 of walk and two months after walk. In the non-active group- the assessment will be evaluated at baseline and after 6 months of usual care. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |