- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06606743
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
39
Phase
- 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 Locations
-
-
Florida
-
Coral Gables, Florida, United States, 33146
- University of Miami
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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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Confirmed diagnosis of Parkinson's disease
- Between the ages of 30-90 years of age;
- 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:
- Uncontrolled cardiovascular disease that prevents participation in a training program
- Documented HIV infection or another immunodeficiency syndrome
- Other neuromuscular diseases besides Parkinson's disease
- Current musculoskeletal injury that prevents exercise.
- 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 |
Intervention / Treatment |
|---|---|
|
Experimental: High-Intensity Interval Training
Participants in this group will receive high-intensity interval training 2 times per week for 10 consecutive weeks.
|
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.
|
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
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.
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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
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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
September 20, 2024
Primary Completion (Actual)
June 30, 2025
Study Completion (Actual)
June 30, 2025
Study Registration Dates
First Submitted
September 16, 2024
First Submitted That Met QC Criteria
September 20, 2024
First Posted (Actual)
September 23, 2024
Study Record Updates
Last Update Posted (Estimated)
August 15, 2025
Last Update Submitted That Met QC Criteria
August 14, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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