ParKinWalk: Physical Activity and Long Group-walking for Motor Impairment and Quality of Life in Parkinson's Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Supervised gait performance dual task gait
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
The clinician and outcome assessors at the beginning and after the training/no intervention will not have access to the assigned arm
Eligibility Criteria
- Ages
- 30 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •impulsive compulsive disorder
- •severe depression
Arms & Interventions
Physical exercise program and Long-walking
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.
Intervention: Exercise program followed by long walk in group (Other)
Usual care
The subjects will be followed according to current standard.
Control group-intervention
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.
Intervention: Exercise program followed by long walk in group (controls) (Other)
Outcomes
Primary Outcomes
Supervised gait performance dual task gait
Time Frame: 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.
Step variability using wearing sensors technology in one-minute supervised dual task walking (Rehagait Hasomed as wearing sensors)
unsupervised gait performance normal gait
Time Frame: 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.
Step variability using wearing sensors technology in one-day unsupervised walking (GaitUp Physilog sensors)
Supervised gait performance normal gait
Time Frame: 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.
Step variability using wearing sensors technology in one-minute supervised walking (rehagait, Hasomed as wearing sensors)
Secondary Outcomes
- Unified parkinson´s disease Rating Scale part 3 (0-132 points) Higher scores mean worse outcomes(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.)
- Parkinson´s disease Quality of life questionnaire (PDQ-39) (0-117 points) Lower scores mean worse outcomes(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.)
Investigators
Andrea Pilotto
Principal Investigator
Università degli Studi di Brescia