Interval Training and Parkinson's Disease

August 14, 2025 updated by: Joseph Signorile, University of Miami

The Comparative Impacts of High-Intensity Interval Training and Power Training on Heart Rate Variability, Gait, and Functional Performance in Patients With Parkinson's Disease

This research is designed to compare the impact of high-intensity interval training and high-velocity circuit resistance training on heart rate variability, gait, and functional performance in patients with Parkinsons disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Coral Gables, Florida, United States, 33146
        • University of Miami
      • Coral Gables, Florida, United States, 33147
        • Laboratory of Neruomuscular Research and Active Aging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Confirmed diagnosis of Parkinson's disease
  2. Between the ages of 30-90 years of age;
  3. Movement Disorder Society-Unified Parkinson's Disease Rating Scale ≤2, which will be provided by the participant's medical provider and be evaluated within 1 year of the study's inception.

Exclusion Criteria:

  1. Uncontrolled cardiovascular disease that prevents participation in a training program
  2. Documented HIV infection or another immunodeficiency syndrome
  3. Other neuromuscular diseases besides Parkinson's disease
  4. Current musculoskeletal injury that prevents exercise.
  5. Having a pacemaker or other internal medical devices

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High-Intensity Interval Training
Participants in this group will receive high-intensity interval training 2 times per week for 10 consecutive weeks.
Behavioral: High-Intensity Interval Training
Participants will receive a total of 20 in-person sessions of 45 minutes duration. Subjects perform high-speed movements with minimal recovery between movements. Hand weight will be used to increase intensity as training progresses.
Active Comparator: High-Velocity Circuit Resistance Training
Participants in this group will receive high-velocity circuit resistance training 2 times per week for 10 consecutive weeks.
Behavioral: High-Velocity Circuit Resistance Training
Participants in this group will perform a total of 20 in-person training sessions using 12 resistance exercises performed in 3 circuits with minimal recovery between exercises.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Heart Rate Variability
Time Frame: Baseline, 10 weeks
After a 10-minute supine rest on a padded treatment table, subjects will breathe at a rate of six breaths per minute for two minutes. The heart rate will be monitored using a Polar heart rate monitor and variations will be detected using the elite application via mobile device.
Baseline, 10 weeks
Changes in the Six-Minute Walk Test
Time Frame: Baseline, 10 weeks
The objective of the test is to walk as far as possible for six minutes. The subject will walk at a normal pace around a marked course for six minutes. The subject may stop to rest and begin again at will. The distance covered indicates aerobic fitness. The further a person walks, the better their cardiovascular condition. The units are meters.
Baseline, 10 weeks
Changes in the Ten-Meter Walk Test
Time Frame: Baseline, 10 weeks
The ten-meter walk test will be used to assess gait velocity. The participants will be asked to walk as quickly as possible in a straight line on a 10-m course marked at 0, 2, 8 and 10 m. On verbal command, participants will start on the 0-m mark and stop when they cross the 10-m mark. The total time to ambulate from the 2-m mark to the 8-m mark (6 m total) will be timed to the hundredth of a second. Two trials will be performed, and the average will be documented in meters per second. One-minute recoveries will be provided between trials. Total time is 420 seconds.
Baseline, 10 weeks
Changes in the Five Times Sit-to-Stand Test
Time Frame: Baseline, 10 weeks
The five time sit-to-stand test will be used to assess functional lower body strength. The participant will sit with their arms folded across their chest and their back against the chair. On verbal command, the participant will stand up and sit down 5 times as quickly as possible. Timing begins at "Go" and ends when the buttocks touch the chair after the 5th repetition. One practice and two testing trials will be performed. Time will be measured in seconds.
Baseline, 10 weeks
Changes in Heart Rate Recovery
Time Frame: Baseline, 10 weeks
Following the Six-Minute Walk Test, participants will be asked to sit quietly for one-minute and heart rate recovery will be determined by analyzing the participant's heart rate immediately following the Six-Minute Walk Test and again after the one-minute recovery. The difference in beats between the two times will be calculated and used for analysis
Baseline, 10 weeks
Changes in One Repetition Maximum Strength
Time Frame: Baseline, 10 weeks
A one-repetition maximum test measures the maximum load that an individual can lift only a single time throughout the full range of motion of the chest press and leg press exercises using proper form. All subjects' one-repetition maximum values will be determined within four to five trials. The units of measure are kilograms. Testing is performed on computerized, pneumatic machines.
Baseline, 10 weeks
Changes in Neuromuscular Power Testing
Time Frame: Baseline, 10 weeks
Peak muscle power is then measured at eight relative intensities (40, 50, 60, 70, and 80% of one repetition maximum) on the computerized pneumatic machines. For each repetition, the concentric phase is performed as fast as possible, and the eccentric phase lasts between 2 and 3 seconds. Power testing is done for the leg press and chest press, and the unit of measurement is Watts.
Baseline, 10 weeks
Changes in Swing time of Gait
Time Frame: Baseline, 10 weeks
Movement analyses will be performed during the ten-meter walk test. The measure will be swing time. Swing time is how long it takes to swing the back foot forward to initiate a new step. The unit of measurement is seconds.
Baseline, 10 weeks
Changes in Stance Time of Gait
Time Frame: Baseline, 10 weeks
Movement analyses will be performed during the ten-meter walk test. The measure will be stance time. Stance time is the duration of the time between heel strike and toe off of the same foot. The unit of measurement is seconds.
Baseline, 10 weeks
Changes in Double Support time of Gait
Time Frame: Baseline, 10 weeks
Movement analyses will be performed during the ten-meter walk test. The measure will be double support time. Double support time is how long both feet are in contact with the ground. The unit of measurement is seconds.
Baseline, 10 weeks
Changes in Step Time of Gait
Time Frame: Baseline, 10 weeks
Movement analyses will be performed during the ten-meter walk test. The measure will be step time. Step time is how long one foot is in contact with the ground. The unit of measurement is seconds.
Baseline, 10 weeks
Changes in Cadence of Gait
Time Frame: Baseline, 10 weeks
Movement analyses will be performed during the ten-meter walk test. The measure will be cadence. Cadence is the number of steps per minute. The unit of measurement is steps per minute.
Baseline, 10 weeks
Changes in Stride Length of Gait
Time Frame: Baseline, 10 weeks
Movement analyses will be performed during the ten-meter walk test. The measure will be stride length. Stride length is the distance covered when a person takes two steps. The unit of measurement is meters.
Baseline, 10 weeks
Changes in Step Length of Gait
Time Frame: Baseline, 10 weeks
Movement analyses will be performed during the ten-meter walk test. The measure will be step length. Step length is the distance covered when a person takes one step. The unit of measurement is meters.
Baseline, 10 weeks
Changes in speed of Gait
Time Frame: Baseline, 10 weeks
Movement analyses will be performed during the ten-meter walk test. The measure will be speed. Gait speed is how fast a person walks. The unit of measurement is meters per second.
Baseline, 10 weeks
Changes in Stride Width of Gait
Time Frame: Baseline, 10 weeks
Movement analyses will be performed during the ten-meter walk test. The measure will be stride width. Stride width is the side-to-side distance between the line of the two feet during gait. The measurement is in meters.
Baseline, 10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in the Parkinson's Disease Questionnaire-39
Time Frame: Baseline, 10 weeks
The Parkinson's Disease Questionnaire-39 is a 39-item self-report questionnaire that assesses Parkinson's disease-specific health-related quality over the last month across the eight quality of life dimensions and specific dimensions of functioning and well-being. Each question is scored from 0-4 points, with lower scores reflecting better quality of life.
Baseline, 10 weeks
Non-Motor Symptoms Scale for Parkinson's Disease
Time Frame: Baseline, 10 weeks
The Non-Motor Symptoms Scale for Parkinson's Disease is a 30-item validated and reliable measure of non-motor symptoms that many patients with Parkinson's Disease experience. The scale is grouped into nine domains including cardiovascular, sleep/fatigue, attention/memory, gastrointestinal, urinary, sexual function, perceptual problems/hallucinations, mood/cognition, and miscellaneous. The score is based on the degree of severity (from 0-3) and frequency (from 1-4). The test is administered by a healthcare professional in an interview format.
Baseline, 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Miami

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joseph F. Signorile, PhD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20240865

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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