NCT06606743

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

September 20, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

9 months

First QC Date

September 16, 2024

Last Update Submit

August 14, 2025

Conditions

Keywords

Interval TrainingResistance Training

Outcome Measures

Primary Outcomes (16)

  • 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.

    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.

    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.

    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.

    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

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Baseline, 10 weeks

Secondary Outcomes (2)

  • Changes in the Parkinson's Disease Questionnaire-39

    Baseline, 10 weeks

  • Non-Motor Symptoms Scale for Parkinson's Disease

    Baseline, 10 weeks

Study Arms (2)

High-Intensity Interval Training

EXPERIMENTAL

Participants in this group will receive high-intensity interval training 2 times per week for 10 consecutive weeks.

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.

Behavioral: High-Velocity Circuit Resistance Training

Interventions

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-Intensity Interval 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.

High-Velocity Circuit Resistance Training

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Miami

Coral Gables, Florida, 33146, United States

Location

Laboratory of Neruomuscular Research and Active Aging

Coral Gables, Florida, 33147, United States

Location

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Joseph F. Signorile, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 16, 2024

First Posted

September 23, 2024

Study Start

September 20, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

August 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations