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

Not Applicable

Completed

• Conditions: Parkinson Disease; Healthy Aging

• Registration Number: NCT04266782
• Lead Sponsor: Università degli Studi di Brescia

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 Timeline

• Study Start: 2019-05-01
• Primary Completion: 2019-11-30
• Status Verified: 2020-02
• Study Completion: 2020-02-01
• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-11
• Last Update Submitted: 2020-02-11
• Study First Posted: 2020-02-12
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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)
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 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)

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Department of Neurology ASST Spedali Civili Brescia; 🇮🇹 Brescia, Lombardia, Italy