Daily Undulating Periodization Methods With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

A Comparison of Daily Undulating Periodization Methods With and Without Functional Exercises in Individuals With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03867877
• Other study ID #: 20181119
• Status: Completed
• Phase: N/A
• Start date: January 11, 2019
• Est. completion date: July 9, 2019

Study information

• Verified date: July 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 9, 2019
• Est. primary completion date: July 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Weight-Lifting Exercise Program

Intervention

Other:
• Periodized 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.
• Simple 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.

Locations

Country	Name	City	State
United States	Max Orovitz Laboratories	Coral Gables	Florida
United States	Max Orovitz Laboratory	Coral Gables	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2-4 minutes
Primary	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.	30 minutes
Primary	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.	10 minutes
Primary	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.	10 minutes
Primary	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.	5 minutes
Primary	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	15 minutes