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

Not Applicable

Completed

• Conditions: Parkinson Disease; Healthy Aging
• Interventions: Other: Exercise program followed by long walk in group; Other: Exercise program followed by long walk in group (controls)

• 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

Arm && Interventions

Group	Intervention	Description
Physical exercise program and Long-walking	Exercise program followed by long walk in group	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.
Control group-intervention	Exercise program followed by long walk in group (controls)	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.

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