Parkinson DiseaseNCT03867877
Daily Undulating Periodization Methods With Parkinson's Disease
A study testing Periodized training with motor practice and Simple Periodized Training in people with Parkinson Disease and Weight-Lifting Exercise Program, run by University of Miami at 2 sites in United States.
Trial summary
Compare periodized (cyclic) resistance training with and without motor training specific to activities of daily living. Read more about this study
- Who is it for?
- Ages 40 to 89 years
- Conditions the study is for
- Parkinson Disease, Weight-Lifting Exercise Program
- What is being tested?
- Periodized training with motor practice and Simple Periodized Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Jan 2019to 9 Jul 2019
- 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 40 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Max Orovitz Laboratories
Coral Gables, Florida, 33146-2416
Max Orovitz Laboratory
Coral Gables, Florida, 33146-2416
About this study
Official title: A Comparison of Daily Undulating Periodization Methods With and Without Functional Exercises in Individuals With Parkinson's Disease
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.
- Conditions
- Parkinson Disease, Weight-Lifting Exercise Program
- Being tested
- Periodized training with motor practice, Simple Periodized Training
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodized training with motor practiceOther
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.
Simple Periodized TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Periodized Training with Motor Practice | Experimental | 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. Receives: Other: Periodized training with motor practice |
| Simple Periodized Training | Experimental | 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 Receives: Other: Simple Periodized Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-4 minutes
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.
Measured: 30 minutes
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.
Measured: 10 minutes
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.
Measured: 10 minutes
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.
Measured: 5 minutes
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
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start11 Jan 2019
- Primary completion9 Jul 2019
- Study completion9 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 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
- NCT03867877
- Sponsor's protocol ID
- 20181119
- Status last verified
- Jul 2019
- First submitted
- 6 Mar 2019
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Daily Undulating Periodization Methods With and Without Functional Exercises in Individuals With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03867877
- Acronym / sponsor ID
- 20181119
- Conditions
- Parkinson Disease, Weight-Lifting Exercise Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 9 Jul 2019 (actual)
- Study completion
- 9 Jul 2019 (actual)
- First posted
- 8 Mar 2019 (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.
Compare periodized (cyclic) resistance training with and without motor training specific to activities of daily living.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodized Training with Motor Practice | Experimental | Other: Periodized training with motor practiceStrength 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. |
| Simple Periodized Training | Experimental | Other: Simple Periodized TrainingStrength 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 |
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Periodized training with motor practiceExercises 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. | Other | Periodized Training with Motor Practice |
| Simple Periodized TrainingExercises 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. | Other | Simple Periodized Training |
Primary outcome
Timed Up and Go Test (TUG)
Time frame: 2-4 minutes
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.
Strength Test
Time frame: 30 minutes
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.
Gait Test
Time frame: 10 minutes
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.
Seated Medicine Ball Chest Throw
Time frame: 10 minutes
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.
30 Second Sit-to-Stand Power Test
Time frame: 5 minutes
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.
Mini Best test
Time frame: 15 minutes
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
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 11 Jul 2019.
- Derived from this study: PubMed 33927114Strand 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.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Recruiting
Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease
Parkinson's Disease (PD)
Active, not recruitingPhase 2
A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
Parkinson&Amp;#39;s Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Not yet recruiting
Cognitive-Motor Training for Gait Adaptability in Parkinson Disease
Parkinson Disease
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 Periodized training with motor practice and Simple Periodized Training in people with Parkinson Disease and Weight-Lifting Exercise Program, 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 4 inclusion and 11 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 11 Jul 2019. 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?
Timed Up and Go Test (TUG) (time frame: 2-4 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03867877, which also lists 1 linked publication.
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 11 Jul 2019.