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

Parkinson Disease Clinical Trial

— ParKInWalk  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04266782
• Other study ID #: 19/03
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: February 2020
• Source: Università degli Studi di Brescia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 1, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Aging
• Parkinson Disease

Intervention

Other:
• Exercise 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
• Exercise 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

Locations

Country	Name	City	State
Italy	Department of Neurology ASST Spedali Civili Brescia	Brescia	Lombardia

Sponsors (2)

Lead Sponsor	Collaborator
Università degli Studi di Brescia	University of Kiel

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.