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

NCT ID: NCT04266782

Last Updated: 2020-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-02-01

Brief Summary

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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

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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.

Conditions

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Parkinson Disease Healthy Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The clinician and outcome assessors at the beginning and after the training/no intervention will not have access to the assigned arm

Study Groups

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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.

Group Type EXPERIMENTAL

Exercise program followed by long walk in group

Intervention Type OTHER

The subjects will be included in a training exercise program for three months followed by a long-walk in group

Usual care

The subjects will be followed according to current standard.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Exercise program followed by long walk in group (controls)

Intervention Type OTHER

The controls matched for age will perform the same exercise program and long walk as the PD subjects

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Kiel

OTHER

Sponsor Role collaborator

Università degli Studi di Brescia

OTHER

Sponsor Role lead

Responsible Party

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Andrea Pilotto

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alessandro Padovani

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Brescia

Locations

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Department of Neurology ASST Spedali Civili Brescia

Brescia, Lombardy, Italy

Site Status

Countries

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Italy

Other Identifiers

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19/03

Identifier Type: -

Identifier Source: org_study_id

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