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

Primary Purpose

Parkinson Disease, Healthy Aging

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Exercise program followed by long walk in group
Exercise program followed by long walk in group (controls)
Sponsored by
Università degli Studi di Brescia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Neurology ASST Spedali Civili Brescia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Active Comparator

Arm Label

Physical exercise program and Long-walking

Usual care

Control group-intervention

Arm Description

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.

The subjects will be followed according to current standard.

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.

Outcomes

Primary Outcome Measures

Supervised gait performance normal gait
Step variability using wearing sensors technology in one-minute supervised walking (rehagait, Hasomed as wearing sensors)
unsupervised gait performance normal gait
Step variability using wearing sensors technology in one-day unsupervised walking (GaitUp Physilog sensors)
Supervised gait performance dual task gait
Step variability using wearing sensors technology in one-minute supervised dual task walking (Rehagait Hasomed as wearing sensors)

Secondary Outcome Measures

Parkinson´s disease Quality of life questionnaire (PDQ-39) (0-117 points) Lower scores mean worse outcomes
PDQ-39 will be assessed in patients
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

Full Information

First Posted
February 5, 2020
Last Updated
February 11, 2020
Sponsor
Università degli Studi di Brescia
Collaborators
University of Kiel
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1. Study Identification

Unique Protocol Identification Number
NCT04266782
Brief Title
ParKinWalk: Physical Activity and Long Group-walking for Parkinson's Disease
Acronym
ParKInWalk
Official Title
ParKinWalk: Physical Activity and Long Group-walking for Motor Impairment and Quality of Life in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
February 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi di Brescia
Collaborators
University of Kiel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Healthy Aging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
InvestigatorOutcomes Assessor
Masking Description
The clinician and outcome assessors at the beginning and after the training/no intervention will not have access to the assigned arm
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical exercise program and Long-walking
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
The subjects will be followed according to current standard.
Arm Title
Control group-intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise program followed by long walk in group
Intervention Description
The subjects will be included in a training exercise program for three months followed by a long-walk in group
Intervention Type
Other
Intervention Name(s)
Exercise program followed by long walk in group (controls)
Intervention Description
The controls matched for age will perform the same exercise program and long walk as the PD subjects
Primary Outcome Measure Information:
Title
Supervised gait performance normal gait
Description
Step variability using wearing sensors technology in one-minute supervised walking (rehagait, Hasomed as wearing sensors)
Time Frame
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.
Title
unsupervised gait performance normal gait
Description
Step variability using wearing sensors technology in one-day unsupervised walking (GaitUp Physilog sensors)
Time Frame
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.
Title
Supervised gait performance dual task gait
Description
Step variability using wearing sensors technology in one-minute supervised dual task walking (Rehagait Hasomed as wearing sensors)
Time Frame
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 Measure Information:
Title
Parkinson´s disease Quality of life questionnaire (PDQ-39) (0-117 points) Lower scores mean worse outcomes
Description
PDQ-39 will be assessed in patients
Time Frame
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.
Title
Unified parkinson´s disease Rating Scale part 3 (0-132 points) Higher scores mean worse outcomes
Description
Total Movement Disorder Society-Unified Parkinson's disease Rating Scale part 3 motor score
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Padovani
Organizational Affiliation
Università degli Studi di Brescia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology ASST Spedali Civili Brescia
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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