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Training and Parkinson's

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03434327
Recruitment Status : Completed
First Posted : February 15, 2018
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Joseph Signorile, University of Miami

Brief Summary:
The purpose of the current study is to compare the impacts of specifically designed power training and strength training programs on function and physical performance in Parkinson's patients. Specific aims are to examine the impact of these interventions on performance variables such as balance, strength, power, posture, gait and physical function.

Condition or disease Intervention/treatment Phase
Parkinson Disease Weight-Lifting Exercise Program Other: Strength Training Other: Power Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Comparative Impacts of Power Training and Strength Training Programs on Neuromuscular Performance and Other Physical Measurements in Individuals With Parkinson's Disease
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : August 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Strength Training
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. All training will be performed on Keiser air-driven machines. Subjects will perform 10 exercises targeting all major muscle groups. The training will last for12 consecutive weeks, for a total of 24 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: Strength Training
Eleven resistance training exercises performed on pneumatic resistance training machines using 2 second concentric and 3 second eccentric contractions at 75-80% of each subjects maximal strength. Subjects will perform 3 sets per exercise, two times per week for 12 weeks.

Experimental: Power Training
For power training the subjects will perform the concentric phase at high speed, while eccentric portion will last approximately 2 sec. Loads will vary from 30-80% of the subject's maximum depending on the biomechanical nature of the joints involved in the exercise. All 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 24 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: Power Training
Eleven resistance training exercises performed on pneumatic resistance training machines using maximum speed concentric and 3 second eccentric contractions at the load that produces the highest power for the individual. Subjects will perform 3 sets per exercise, two times per week for 12 weeks.




Primary Outcome Measures :
  1. 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 cm, walk a 3-m 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. 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 s 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 ROM. 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.

  3. Power test [ Time Frame: 30 minutes ]
    After measurement of the participant's strength for each movement, we will measure the participant's power using the same machines. The participant's power will be assessed at 40%, 50%, 60%, 70%, 80%, or 90% of the participant's maximum strength depending on the exercise. Before performing each exercise, the participant will be instructed to perform the exercises as fast as possible through the full ROM. A 3-minute rest will be provided between exercises. Three trials will be performed per exercise and the highest power recorded will be designated as the participant's peak power.

  4. Gait Test [ Time Frame: 20 minutes ]
    The gait test will be a standard 10m gait test at usual (two trials) and maximum (2 trials) speed. The participant will be timed using a wireless infrared timing system and movement analysis will be performed using our 3D movement analysis system and force plates.


Secondary Outcome Measures :
  1. The Falls Efficacy Scale (FES) [ Time Frame: 5 minutes ]
    This will be used to determine the participant's level of self-efficacy (how the participant feels about himself or herself) as it relates to fear of falling.

  2. Berg Balance Scale. [ Time Frame: 15-20 minutes ]

    The Berg Balance Scale is a 14-item test designed to measure the participant's standing balance while the participant are standing still and moving. The test takes about 15-20 minutes and tests the following activities:

    Sitting to standing, Standing unsupported, Sitting unsupported, Standing to sitting, Transfers, Standing with eyes closed, Standing with feet together, Reaching forward with outstretched arm, Retrieving object from floor, Turning to look behind, Turning 360 degrees, Placing alternate foot on stool, Standing with one foot in front, and Standing on one foot.


  3. Dynamic Posturography Test [ Time Frame: 5 minutes ]
    The participant will complete a dynamic balance test on a moving platform that rocks around at different speeds and angles and tests how well the participant can keep the participant's balance. For the participant's safety the participant will wear a harness that is attached to the machine so that the participant cannot fall.

  4. Manual dexterity [ Time Frame: 15 minutes ]
    Hand tremor will be tested using an infrared camera. The participant will then be asked to turn over five coins and button the front of a shirt.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 40 to 89 years old, Hoehn & Yahr Classification of Disability, stage 1-3 who can ambulate with or without an assistive device for at least 50 feet and are able to get up and down from the floor with minimal assist or less. A score of 24 or above on the Folstein Mini-Mental State Exam.

Exclusion Criteria:

  • Stage greater than 4 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, or in a resistance training program within the past year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434327


Locations
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United States, Florida
Max Orovitz Laboratories
Coral Gables, Florida, United States, 33146
Sponsors and Collaborators
University of Miami

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Responsible Party: Joseph Signorile, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03434327    
Other Study ID Numbers: 20180001
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases