Other Disorders of Autonomic Nervous SystemNCT06606743
Interval Training and Parkinson's Disease
A study testing High-Intensity Interval Training and High-Velocity Circuit Resistance Training in people with Other Disorders of Autonomic Nervous System, run by University of Miami at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Other Disorders of Autonomic Nervous System
- What is being tested?
- High-Intensity Interval Training and High-Velocity Circuit Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Sep 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Miami
Coral Gables, Florida, 33146
Laboratory of Neruomuscular Research and Active Aging
Coral Gables, Florida, 33147
About this study
Official title: 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.
- Being tested
- High-Intensity Interval Training, High-Velocity Circuit Resistance Training
- Keywords
- Interval Training, Resistance Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Interval TrainingBehavioural
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.
High-Velocity Circuit Resistance TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Interval Training | Experimental | Participants in this group will receive high-intensity interval training 2 times per week for 10 consecutive weeks. Receives: Behavioral: High-Intensity Interval Training |
| High-Velocity Circuit Resistance Training | Active comparator | Participants in this group will receive high-velocity circuit resistance training 2 times per week for 10 consecutive weeks. Receives: Behavioral: High-Velocity Circuit Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Heart Rate Variability
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.
Measured: Baseline, 10 weeks
Changes in the Six-Minute Walk Test
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.
Measured: Baseline, 10 weeks
Changes in the Ten-Meter Walk Test
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.
Measured: Baseline, 10 weeks
Changes in the Five Times Sit-to-Stand Test
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.
Measured: Baseline, 10 weeks
Changes in Heart Rate Recovery
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
Measured: Baseline, 10 weeks
Changes in One Repetition Maximum Strength
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.
Measured: Baseline, 10 weeks
Changes in Neuromuscular Power Testing
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.
Measured: Baseline, 10 weeks
Changes in Swing time of Gait
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.
Measured: Baseline, 10 weeks
Changes in Stance Time of Gait
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.
Measured: Baseline, 10 weeks
Changes in Double Support time of Gait
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.
Measured: Baseline, 10 weeks
Changes in Step Time of Gait
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.
Measured: Baseline, 10 weeks
Changes in Cadence of Gait
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.
Measured: Baseline, 10 weeks
Changes in Stride Length of Gait
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.
Measured: Baseline, 10 weeks
Changes in Step Length of Gait
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.
Measured: Baseline, 10 weeks
Changes in speed of Gait
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.
Measured: Baseline, 10 weeks
Changes in Stride Width of Gait
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.
Measured: Baseline, 10 weeks
Secondary outcomes (2)
Changes in the Parkinson's Disease Questionnaire-39
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.
Measured: Baseline, 10 weeks
Non-Motor Symptoms Scale for Parkinson's Disease
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.
Measured: Baseline, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start20 Sep 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Disorders of Autonomic Nervous SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Signorile, University of Miami
- Investigators
- Joseph F. Signorile, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606743
- Sponsor's protocol ID
- 20240865
- Status last verified
- Aug 2025
- First submitted
- 16 Sep 2024
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06606743
- Acronym / sponsor ID
- 20240865
- Keywords
- Interval Training, Resistance Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Interval Training | Experimental | Behavioral: High-Intensity Interval TrainingParticipants in this group will receive high-intensity interval training 2 times per week for 10 consecutive weeks. |
| High-Velocity Circuit Resistance Training | Active comparator | Behavioral: High-Velocity Circuit Resistance TrainingParticipants in this group will receive high-velocity circuit resistance training 2 times per week for 10 consecutive weeks. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity Interval TrainingParticipants 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. | Behavioural | High-Intensity Interval Training |
| High-Velocity Circuit Resistance TrainingParticipants 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. | Behavioural | High-Velocity Circuit Resistance Training |
Primary outcome
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Changes in the Parkinson's Disease Questionnaire-39
Time frame: Baseline, 10 weeks
Non-Motor Symptoms Scale for Parkinson's Disease
Time frame: Baseline, 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph F. Signorile, PhD principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Interval Training and High-Velocity Circuit Resistance Training in people with Other Disorders of Autonomic Nervous System, run by University of Miami at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Heart Rate Variability (time frame: Baseline, 10 weeks). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025; AzTrials last refreshed its copy on 29 Oct 2026.