- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03867877
Daily Undulating Periodization Methods With Parkinson's Disease
July 10, 2019 updated by: Joseph Signorile, University of Miami
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
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, 33146-2416
- Max Orovitz Laboratories
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Coral Gables, Florida, United States, 33146-2416
- Max Orovitz Laboratory
-
-
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
40 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- 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
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2-4 minutes
|
|
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.
|
30 minutes
|
|
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.
|
10 minutes
|
|
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.
|
10 minutes
|
|
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.
|
5 minutes
|
|
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:
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
January 11, 2019
Primary Completion (Actual)
July 9, 2019
Study Completion (Actual)
July 9, 2019
Study Registration Dates
First Submitted
March 6, 2019
First Submitted That Met QC Criteria
March 6, 2019
First Posted (Actual)
March 8, 2019
Study Record Updates
Last Update Posted (Actual)
July 11, 2019
Last Update Submitted That Met QC Criteria
July 10, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20181119
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
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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