Back to resultsDaily Undulating Periodization Methods With Parkinson's Disease
Primary Purpose
Parkinson Disease, Weight-Lifting Exercise Program
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Periodized training with motor practice
Simple Periodized Training
Sponsored by
About this trial
This is an interventional health services research trial for Parkinson Disease
Eligibility Criteria
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
Sites / Locations
- Max Orovitz Laboratories
- Max Orovitz Laboratory
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Periodized Training with Motor Practice
Simple Periodized Training
Arm Description
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.
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
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03867877
Brief Title
Daily Undulating Periodization Methods With Parkinson's Disease
Official Title
A Comparison of Daily Undulating Periodization Methods With and Without Functional Exercises in Individuals With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 11, 2019 (Actual)
Primary Completion Date
July 9, 2019 (Actual)
Study Completion Date
July 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Weight-Lifting Exercise Program
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Periodized Training with Motor Practice
Arm Type
Experimental
Arm Description
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.
Arm Title
Simple Periodized Training
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Periodized training with motor practice
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Simple Periodized Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Timed Up and Go Test (TUG)
Description
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
Title
Strength Test
Description
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
Title
Gait Test
Description
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
Title
Seated Medicine Ball Chest Throw
Description
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
Title
30 Second Sit-to-Stand Power Test
Description
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
Title
Mini Best test
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph F Signorile, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Max Orovitz Laboratories
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146-2416
Country
United States
Facility Name
Max Orovitz Laboratory
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146-2416
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33927114
Citation
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.
Results Reference
derived
Learn more about this trial
Daily Undulating Periodization Methods With Parkinson's Disease
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