NCT03867877

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2019

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

March 6, 2019

Last Update Submit

July 10, 2019

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

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.

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

Other: Simple Periodized Training

Interventions

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.

Periodized Training with Motor Practice

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.

Simple Periodized Training

Eligibility Criteria

Age40 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Max Orovitz Laboratories

Coral Gables, Florida, 33146-2416, United States

Location

Max Orovitz Laboratory

Coral Gables, Florida, 33146-2416, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Joseph F Signorile, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 6, 2019

First Posted

March 8, 2019

Study Start

January 11, 2019

Primary Completion

July 9, 2019

Study Completion

July 9, 2019

Last Updated

July 11, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations