Clinical trial NCT03867877: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Weight-Lifting Exercise Program
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2019-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Timed Up and Go Test (TUG)
timeFrame: 2-4 minutes
measure: Strength Test
timeFrame: 30 minutes
measure: Gait Test
timeFrame: 10 minutes
measure: Seated Medicine Ball Chest Throw
timeFrame: 10 minutes
measure: 30 Second Sit-to-Stand Power Test
timeFrame: 5 minutes
measure: Mini Best test
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Max Orovitz Laboratories
state: Florida
city: Coral Gables
country: United States
facility: Max Orovitz Laboratory
state: Florida
Study officials:
affiliation: University of Miami
name: Joseph F Signorile, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.