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

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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Healthy Aging
• Intervention / Treatment: Other: Exercise program followed by long walk in group; Other: Exercise program followed by long walk in group (controls)

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardia
    • Brescia, Lombardia, Italy, 25123
      • Department of Neurology ASST Spedali Civili Brescia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
No Intervention: Usual care; The subjects will be followed according to current standard.
Active Comparator: 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.	Other: 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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Università degli Studi di Brescia
• Collaborators: University of Kiel
• Investigators: Principal Investigator: Alessandro Padovani, Università degli Studi di Brescia

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 19/03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Wearing sensor will be available after completion of the trial
• IPD Sharing Time Frame: After the completion fo the trial this will be presented in a publication
• IPD Sharing Access Criteria: upon reasonable request
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No