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NCT Number: NCT04266782

ParKinWalk: Physical Activity and Long Group-walking for 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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Healthy Aging Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology ASST Spedali Civili Brescia

Brescia, Lombardy, 25123, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise program followed by long walk in group

Other

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

Exercise program followed by long walk in group (controls)

Other

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

Primary outcomes

  1. Supervised gait performance normal gait

    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.

    Step variability using wearing sensors technology in one-minute supervised walking (rehagait, Hasomed as wearing sensors)

  2. unsupervised gait performance normal gait

    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.

    Step variability using wearing sensors technology in one-day unsupervised walking (GaitUp Physilog sensors)

  3. Supervised gait performance dual task gait

    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.

    Step variability using wearing sensors technology in one-minute supervised dual task walking (Rehagait Hasomed as wearing sensors)

Secondary outcomes

  1. Parkinson´s disease Quality of life questionnaire (PDQ-39) (0-117 points) Lower scores mean worse outcomes

    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.

    PDQ-39 will be assessed in patients

  2. Unified parkinson´s disease Rating Scale part 3 (0-132 points) Higher scores mean worse outcomes

    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.

    Total Movement Disorder Society-Unified Parkinson's disease Rating Scale part 3 motor score

Sponsors and collaborators

Lead sponsor

Università degli Studi di Brescia

Other

Collaborators

  • University of Kiel

Registry information

Official study title

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

Acronym: ParKInWalk

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Feb 12, 2020
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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