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Blood Lactate Concentrations With and Without Exercise in Parkinson's Disease and Multiple Sclerosis Patients (PDMSLac)

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ClinicalTrials.gov Identifier: NCT02184494
Recruitment Status : Completed
First Posted : July 9, 2014
Results First Posted : November 16, 2015
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Michael J. Ormsbee, Florida State University

Brief Summary:

Fatigue is one of the most common and debilitating symptoms experienced in Parkinson's Disease (PD) and Multiple Sclerosis (MS). There are multiple proposed mechanisms of disorder-related fatigue, however, it is unknown whether PD or MS patients experience compromised blood lactate responses to an acute bout of exercise, subjecting them to exercise-related fatigue. These populations may experience higher energy expenditure at rest due to increased rigidity, however, limited data exists investigating resting energy expenditure in these populations.

Researchers hypothesize that PD and MS patients will display higher resting energy expenditure than healthy age-matched controls, and that level of energy expenditure will correlate with amount of rigidity or spasticity. Also, we hypothesize that baseline levels of lactate will not be different between PD/MS and control groups, but post-exercise blood lactate levels will be significantly higher in the PD/MS groups.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Multiple Sclerosis Device: pro5 AIRdaptive Power Plate (Badhoevedorp, The Netherlands) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of A Double-Blind Placebo-Controlled Study of the Effect of Beta-Alanine and Whole Body Vibration on Neurologic Motoric Function, Vascular Function, and Quality of Life in Parkinson's Disease
Study Start Date : August 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014


Arm Intervention/treatment
Experimental: Blood Lactate Response in PD
This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate (pro5 AIRdaptive Power Plate (Badhoevedorp, The Netherlands)), and one on the ground.
Device: pro5 AIRdaptive Power Plate (Badhoevedorp, The Netherlands)

Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.

Whole Body Vibration


Experimental: Blood Lactate Response in MS
This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate (pro5 AIRdaptive Power Plate (Badhoevedorp, The Netherlands)), and one on the ground.
Device: pro5 AIRdaptive Power Plate (Badhoevedorp, The Netherlands)

Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.

Whole Body Vibration


Experimental: Blood Lactate Responses in Controls
This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate (pro5 AIRdaptive Power Plate (Badhoevedorp, The Netherlands)), and one on the ground.
Device: pro5 AIRdaptive Power Plate (Badhoevedorp, The Netherlands)

Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.

Whole Body Vibration





Primary Outcome Measures :
  1. Blood Lactate Response [ Time Frame: Before, immediately after, and 10 minutes after the squatting exercise protocol ]
    Measured using a blood lactate analyzer, a finger prick test measured before, after, and 10 minutes after exercise


Secondary Outcome Measures :
  1. Resting Energy Expenditure [ Time Frame: Measured immediately upon arriving to the laboratory. Lasted approximately 25 minutes. ]
    Measured using using indirect calorimetry with a ventilated face mask and noseclip (Parvometrics, Sandy, UT). This involves laying supine for 30 to 60 minutes.


Other Outcome Measures:
  1. Neurological Function [ Time Frame: Measured immediately after the resting energy expenditure measurement, and before the other questionnaires. Lasted approximately 15 minutes. ]
    Neurological functional state will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). Of the 5 sections of the examination, two parts were used. Part II (self-evaluation of aspects of the experiences of daily living) consisted of 13 Likert scale questions (graded 0 to 4, with 4 being most severe), including speech, saliva and drooling, chewing and swallowing, eating tasks, dressing, hygiene, handwriting, doing hobbies and other activities, turning in bed, tremor, getting out of bed/car/deep chair, walking and balance, and freezing. Part III (motor evaluation performed by trained research personnel) consisted of 14 Likert scale questions (graded 0 to 4, with 4 being most severe), including speech, facial expression, rigidity, finger tapping, hand movements, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, etc... Values were summed, with higher values indicating increased impairment and disability.

  2. Health and Activity Questionnaire [ Time Frame: Collected immediately after the UPDRS (if PD population), or immediately after the resting energy expenditure measurement (if MS or healthy, older adult). Measured with other questionnaires and immediately before squatting exercise. Lasted ~10 minutes. ]

    Short Form 36 Health Survey questionnaire: patient-reported survey of 36 questions, yielding the participant's degree of health on 8 different scale scores (each scale summed into a 0-100 score, with lower scores indicating more disability). The eight scales include vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health.

    Schwab and England Activities of Daily Living Questionnaire: self-rated, single item assessment of the participant's ability to perform daily activities with speed and independence, measured using a Likert scale of percentages, in 10% increments. A score of 100% indicates total independence, while 0% indicates complete dependence.


  3. Fatigue/Depression Assessment [ Time Frame: Collected at the same time as the other questionnaires. Lasted approximately 5-7 minutes. ]

    Fatigue Severity Scale: 9-item, self-reporting rating that rates the severity of your fatigue symptoms on a Likert scale ranging from 1 to 7, with 1 indicating strong disagreement, and 7 indicating strong agreement. The sum of scores is calculated. The lower the score, the more severe the participant's fatigue symptoms.

    Beck's Depression Inventory: 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression on a Likert scale ranging from 0 to 3, with 3 being the most severe. The sum of scores is calculated. A high score indicates more severe depression and related symptoms.




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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Parkinson's Disease Stage I-IV (be standard criteria H&Y scale)
  • Multiple Sclerosis
  • Healthy, age-matched controls
  • 45 to 90 years old

Exclusion Criteria:

  • Dementia
  • Co-morbid neurologic factors
  • Individuals without independent ambulation
  • Significant heart and respiratory disease
  • Debilitating arthritis

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): NCT02184494


Locations
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United States, Florida
Fitness and Wellness Center
Tallahassee, Florida, United States, 32306
Balance Disorders Clinic
Tallahassee, Florida, United States, 32308
Sponsors and Collaborators
Florida State University
Investigators
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Principal Investigator: Michael J Ormsbee, Ph.D. Florida State University
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Responsible Party: Michael J. Ormsbee, Assistant Professor, Florida State University
ClinicalTrials.gov Identifier: NCT02184494    
Other Study ID Numbers: 2014:12658
HPN ( Other Identifier: FSU Human Performance and Sports Nutrition )
First Posted: July 9, 2014    Key Record Dates
Results First Posted: November 16, 2015
Last Update Posted: March 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: If, and when requested, participants may review findings by contacting the PI. Other than participants, only investigators will have access to the data.
Keywords provided by Michael J. Ormsbee, Florida State University:
Parkinson's Disease
Multiple Sclerosis
Fatigue
Resting Energy Expenditure
Whole Body Vibration
Exercise
Blood Lactate
Additional relevant MeSH terms:
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Parkinson Disease
Multiple Sclerosis
Sclerosis
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases