ParKinWalk: Physical Activity and Long Group-walking for Parkinson's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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ParKinWalk: Physical Activity and Long Group-walking for Motor Impairment and Quality of Life in Parkinson's Disease

Conditions
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Parkinson Disease, Healthy Aging

Intervention / Treatment
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* Other: Exercise program followed by long walk in group
* Other: Exercise program followed by long walk in group (controls)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parkinson´s disease diagnosis stable dopaminergic treatment ( stable dose in the last three months before baseline evaluation) Exclusion Criteria: gait impairment due to other medical conditions dementia impulsive compulsive disorder severe depression

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical exercise program and Long-walking<br>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. | Other: Exercise program followed by long walk in group<br>* The subjects will be included in a training exercise program for three months followed by a long-walk in group<br>|
| No Intervention: Usual care<br>The subjects will be followed according to current standard. | |
| Active Comparator: Control group-intervention<br>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. | Other: Exercise program followed by long walk in group (controls)<br>* The controls matched for age will perform the same exercise program and long walk as the PD subjects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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. |