Parkinson's Autonomic Responses to Treadmill Walking

NCT03156400 | Completed

• 1 other identifier: 20160709
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare examine autonomic and cardiovascular responses to peak exercise testing in Parkinson's disease patients in varying stages of the disease, and healthy, age-matched participants. Participants will be asked to complete a peak exercise test on a motorized treadmill. Heart rate, blood pressure, norepinephrine, and other markers for cardiovascular function will be assessed at rest, during exercise, and post-exercise. The hypothesis to be tested is that Parkinson's disease patients will exhibit a decreased autonomic and cardiovascular response to exercise when compared to patients' healthy age-matched counterparts. The investigators secondary hypothesis is that Parkinson's disease patients in more advanced stages will exhibit a greater decrease in response when compared to these patients' Stage 1 counterparts, or healthy age-matched counterparts.

Conditions

Parkinson Disease; Autonomic Dysfunction

Outcome Measures

Primary Outcomes (3)

• Blood Pressure Response

  Blood Pressure responses during increases in workload using automated blood pressure cuff

  12 minute

• Cardiac Output using ergospirometry

  Cardiac responses during increases in workload using PhysioFlow automated respiratory gas ergospirometer

  12 minute

• Vascular Resistance using ergospirometry

  Changes in resistive force during increases in workload using PhysioFlow automated respiratory gas ergospirometer

  12 minutes

Study Arms (2)

Parkinson's disease

ACTIVE COMPARATOR

Men and women can be included in the study if they are between 50 and 85 years of age and meet the following criteria: Have received clearance from a primary physician to perform a exercise stress test. Will be able to walk on a motorized treadmill with supporting harness system. Individual with PD who has recently had a diagnosis of Stage 1 or 2 on the Hoehn and Yahr scale.

Other: Exercise Stress Test

Healthy Control

ACTIVE COMPARATOR

Men and women can be included in the study if they are between 50 and 85 years of age and meet the following criteria: Have received clearance from a primary physician to perform a exercise stress test. Will be able to walk on a motorized treadmill with supporting harness system. Healthy individual with no unresolved cardiovascular, neuromuscular, and/or musculoskeletal disease.

Other: Exercise Stress Test

Interventions

Exercise Stress Test OTHER

Gradual increase in treadmill grade while collecting respiratory gases.

Healthy Control; Parkinson's disease

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women can be included in the study if these potential participants are between 50 and 85 years of age and meet the following criteria:
• Have received clearance from a primary physician to perform a peak exercise test.
• Will be able to walk on a motorized treadmill with supporting harness system.
• Are Individuals with PD having recently had a diagnosis of Stage 1, or 2, or 3 on the Hoehn and Yahr scale and can present the research team with evidence from the potential participant's physician stating the diagnosis.
• Or,
• The potential participant is a healthy individual with no unresolved cardiovascular, neuromuscular, and/or musculoskeletal disease.

You may not qualify if:

• Men and women will be excluded from participation if the individual:
• Has been advised by a physician not to exercise.
• Is currently participating, or within the past 3 months has participated, in an exercise training program.
• Is currently on any cardiac or blood pressure medication.
• Has any additional neurological disorder.
• Is considered to be at high risk for cardiovascular disease as determined by the - American College of Sports Medicine (ACSM) risk stratification screening questionnaire or their primary physician.
• Is unable to provide informed consent.
• has a Mini-mental score less than 18.
• Is pregnant.
• Is currently a prisoner.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Laboratory of Clinical Research

Coral Gables, Florida, 33127, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Primary Dysautonomias

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Joseph Signorile, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: May 17, 2017
• Study Start: February 15, 2017
• Primary Completion: March 26, 2018
• Study Completion: June 1, 2018
• Last Updated: July 6, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)