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

NCT04266782 | Completed

• 1 other identifier: 19/03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Healthy Aging

Outcome Measures

Primary Outcomes (3)

• Supervised gait performance normal gait

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

  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.

• unsupervised gait performance normal gait

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

  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.

• Supervised gait performance dual task gait

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

  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 Outcomes (2)

• 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.

• 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.

Study Arms (3)

Physical exercise program and Long-walking

EXPERIMENTAL

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.

Other: Exercise program followed by long walk in group

Usual care

NO INTERVENTION

The subjects will be followed according to current standard.

Control group-intervention

ACTIVE COMPARATOR

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.

Other: Exercise program followed by long walk in group (controls)

Interventions

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

Physical exercise program and Long-walking

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

Control group-intervention

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parkinson´s disease diagnosis
• stable dopaminergic treatment ( stable dose in the last three months before baseline evaluation)

You may not qualify if:

• gait impairment due to other medical conditions
• dementia
• impulsive compulsive disorder
• severe depression

Sponsors & Collaborators

• Università degli Studi di Brescia: lead
• University of Kiel: collaborator

Study Sites (1)

Department of Neurology ASST Spedali Civili Brescia

Brescia, Lombardy, 25123, Italy

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Alessandro Padovani

  Università degli Studi di Brescia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The clinician and outcome assessors at the beginning and after the training/no intervention will not have access to the assigned arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 12, 2020
• Study Start: May 1, 2019
• Primary Completion: November 30, 2019
• Study Completion: February 1, 2020
• Last Updated: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After the completion fo the trial this will be presented in a publication
• Access Criteria: upon reasonable request

Locations

IT (1)