Clinical trial NCT04266782: ParKinWalk: Physical Activity and Long Group-walking for Parkinson's Disease
Official title: ParKinWalk: Physical Activity and Long Group-walking for Motor Impairment and Quality of Life in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Healthy Aging
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
Collaborators: name: University of Kiel
First posted: 2020-02-12
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Supervised gait performance normal gait
timeFrame: 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: unsupervised gait performance normal gait
timeFrame: 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: Supervised gait performance dual task gait
timeFrame: 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 outcomes:
measure: Parkinson´s disease Quality of life questionnaire (PDQ-39) (0-117 points) Lower scores mean worse outcomes
timeFrame: 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.
measure: Unified parkinson´s disease Rating Scale part 3 (0-132 points) Higher scores mean worse outcomes
timeFrame: 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.
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Department of Neurology ASST Spedali Civili Brescia
state: Lombardia
Study officials:
affiliation: Università degli Studi di Brescia
name: Alessandro Padovani
role: PRINCIPAL_INVESTIGATOR
References: