Healthy Aging, Parkinson Disease
Conditions
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.
Interventions
OTHERExercise program followed by long walk in group
The subjects will be included in a training exercise program for three months followed by a long-walk in group
OTHERExercise program followed by long walk in group (controls)
The controls matched for age will perform the same exercise program and long walk as the PD subjects
Sponsors
University of Kiel
Università degli Studi di Brescia
Study design
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
Intervention 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
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
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 * dementia * impulsive compulsive disorder * severe depression
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Supervised gait performance normal gait | 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) |
| unsupervised gait performance normal gait | 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 dual task gait | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | PDQ-39 will be assessed in patients |
| 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. | Total Movement Disorder Society-Unified Parkinson's disease Rating Scale part 3 motor score |
Countries
Italy
Outcome results
None listed