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CompletedNCT03867877Updated Jul 11, 2019

Daily Undulating Periodization Methods With Parkinson's Disease

An interventional study of Periodized training with motor practice and Simple Periodized Training in Parkinson Disease and Weight-Lifting Exercise Program, sponsored by University of Miami. Completed at 2 sites in United States. Open to participants aged 40 Years to 89 Years. Per ClinicalTrials.gov, last updated 2019-07-11.

Sponsored by University of Miami · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
40 Years to 89 Years
Sex
All
01

Study summary

Compare periodized (cyclic) resistance training with and without motor training specific to activities of daily living.

Read the detailed description

This study will look at how well two different daily undulating training programs (hypertrophy-strength-power training, versus strength-power-functional training) improve participants' physical functions. All testing procedures will take place at the Max Orovitz Laboratory on the Coral Gables campus. This study will involve a 1-week baseline testing phase, a 2-week familiarization phase, a 9-week intervention phase, and a 1-week post-testing window where subjects must report to the lab for 2 sessions.

02

Conditions studied

  • Parkinson Disease
  • Weight-Lifting Exercise Program

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03

In context

Parkinson Disease

4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.

This study's enrollment of 40 is close to the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

University of Miami is the lead sponsor of 838 studies on the registry; 164 are open to participants now.

Of its 114 completed or terminated interventional studies of FDA-regulated products, 96 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Hoehn \& Yahr Classification of Disability, stage 1-3
  • can ambulate with or without an assistive device for at least 50 feet
  • able to get up and down from the floor with minimal assistance
  • has a score of 24 or above on the Folstein Mini-Mental State Exam

Exclusion criteria

Exclusion Criteria:

  • Greater than Stage 3 on the Hoehn \& Yahr Classification of Disability
  • decline in immune function such as pneumonia or systemic infection
  • progressive degenerative disease besides PD
  • spinal fusion or other orthopedic surgery in the past six months
  • mental disease/psychosis such as dementia
  • greater than minimal assistance required for gait and transfers
  • inability to make regular time commitments to the scheduled training sessions
  • participation in resistance training on a regular basis within the past six months
  • inability to provide consent
  • pregnancy
  • a prisoner
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Periodized Training with Motor Practice

    Strength training will use 75-80% of the subject's maximum for the specific exercise and contractions will occur at 2s concentric and 3s eccentric for the strength day. 30-80% of subjects' maximal strength for the power day with high-speed concentric and 2 second eccentric contractions, and exercises that simulate activities of daily living for the motor practice day. All resistance-training will be performed on Keiser air-driven machines. Subjects will perform 10 exercises targeting all major muscle groups. The training will last for 12 consecutive weeks, for a total of 36 visits. Each visit will be approximately 60 minutes long and will consist of 5 minutes warm-up, 50 minutes of training and five minutes of cool-down.

    Other: Periodized training with motor practice

  • Experimental
    Simple Periodized Training

    Strength training will use 75-80% of the subject's maximum for the specific exercise and contractions will occur at 2 second concentric and 3 second eccentric for the strength day. 30-80% of subjects' maximal strength for the power day, with high speed concentric and 2 second eccentric contractions, and 60-75% of subjects' maximum strength for the hypertrophy day. All resistance-training will be performed on Keiser air-driven machines. Subjects will perform 10 exercises targeting all major muscle groups. The training will last for 12 consecutive weeks, for a total of 36 visits. Each visit will be approximately 60 minutes long and will consist of 5 minutes warm-up, 50 minutes of training and five minutes of cool-down

    Other: Simple Periodized Training

Interventions

  • OtherPeriodized training with motor practice

    Exercises at 75-80% of the subject's maximum for strength exercise using contractions with 2 second concentric and 3 second eccentric for the strength day. 30-80% of subjects' maximal strength for the power day with high-speed concentric and 2 second eccentric contractions, and exercises that simulate activities of daily living for the motor practice day. All resistance-training will be performed on Keiser air-driven machines. Subjects will perform 10 exercises targeting all major muscle groups. The training will last for 12 consecutive weeks, for a total of 36 visits. Each visit will be approximately 60 minutes long and will consist of 5 minutes warm-up, 50 minutes of training and five minutes of cool-down.

  • OtherSimple Periodized Training

    Exercises at 75-80% of the subject's maximum for strength using contractions with 2 second concentric and 3 second eccentric for the strength day. 30-80% of subjects' maximal strength for the power day, with high speed concentric and 2 second eccentric contractions, and for hypertrophy day at 60-75% of subjects' maximum strength. All resistance-training will be performed on Keiser air-driven machines. Subjects will perform 10 exercises targeting all major muscle groups. The training will last for 12 consecutive weeks, for a total of 36 visits. Each visit will be approximately 60 minutes long and will consist of 5 minutes exercise using contractions warm-up, 50 minutes of training and five minutes of cool-down.

06

What researchers measure

Primary outcomes

  1. Timed Up and Go Test (TUG)

    The participant will be asked to stand up from a standard chair with a seat height of between 40 and 50 centimeters, walk a 3-meter distance at a normal pace, turn, walk back to the chair, and sit down. The test takes approximately 2-4 minutes to complete with instructions.

    Time frame: 2-4 minutes

  2. Strength Test

    The participant will perform the concentric phase within the limits of the participant's own specific range of motion for each joint/movement tested over 2 second periods. The tester will gradually increase the resistance for each repetition until the participant are not able to move the lever arm one time through the full range of motion. The participant will be asked how hard the test felt after each repetition and each muscle group will be finished in a maximum of seven repetitions.

    Time frame: 30 minutes

  3. Gait Test

    The gait test will be a standard 10 meter gait test at usual (two trials) and maximum (2 trials) speed. The participant will be timed using a stopwatch.

    Time frame: 10 minutes

  4. Seated Medicine Ball Chest Throw

    Participants will be seated in an armless chair with their backs against the seat back and feet flat on the floor. They will then asked to throw a 3kg medicine ball as far as they can. Subjects are allowed to practice as many times as they want. Two trails will be performed with and a one minute rest will be provided.

    Time frame: 10 minutes

  5. 30 Second Sit-to-Stand Power Test

    The participant will be asked to sit in a chair with their feet flat on the ground and their arms placed across their chest. They will stand fully as many times times as they can in 30 seconds.

    Time frame: 5 minutes

  6. Mini Best test

    This is a 14-item test designed to measure the participant's balance while standing still and moving. The test takes about 15-20 minutes and includes the following activities: * Sit to stand * Rise to toes * Stand on one leg * Compensatory stepping correction - forward * Compensatory stepping correction - backward * Compensatory stepping correction - lateral * Stance (feet together); eyes open, firm surface * Stance (feet together); eyes closed, foam surface * Incline eyes closed * Change in speed * Walk with head turns - horizontal * Walk with pivot turns * Step over obstacles * Timed up and go (TUG) with and without dual task

    Time frame: 15 minutes

07

Study locations

2 sites
  • Max Orovitz Laboratories
    Coral Gables, Florida 33146-2416, United States
  • Max Orovitz Laboratory
    Coral Gables, Florida 33146-2416, United States
08

References and documents

Publications

  • Strand KL, Cherup NP, Totillo MC, Castillo DC, Gabor NJ, Signorile JF. Periodized Resistance Training With and Without Functional Training Improves Functional Capacity, Balance, and Strength in Parkinson's Disease. J Strength Cond Res. 2021 Jun 1;35(6):1611-1619. doi: 10.1519/JSC.0000000000004025. PubMed 33927114 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2019 to primary completion in Jul 2019, 5 months.

Of 1,296 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 5 months is below that.

Counting every sponsor, half of 1,369 studies reached it within 24 months; a quarter within 11 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 6, 2019
First posted
Mar 8, 2019
StartActual
Jan 11, 2019
Primary completionActual
Jul 9, 2019
CompletionActual
Jul 9, 2019
Last update
Jul 11, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03867877
Responsible party
Joseph Signorile (Professor, University of Miami) — Principal investigator
First posted
Mar 8, 2019
Start date
Jan 11, 2019
Primary completion
Jul 9, 2019
Completion
Jul 9, 2019
Last update
Jul 11, 2019

Study contacts

Joseph F Signorile, PhD
principal investigator · University of Miami

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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