Blood Lactate Concentrations With and Without Exercise in Parkinson's Disease and Multiple Sclerosis Patients
PDMSLac
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
2 other identifiers
interventional
34
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2014
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2014
CompletedFirst Posted
Study publicly available on registry
July 9, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
November 16, 2015
CompletedMarch 30, 2017
March 1, 2017
3 months
July 2, 2014
July 2, 2015
March 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood Lactate Response
Measured using a blood lactate analyzer, a finger prick test measured before, after, and 10 minutes after exercise
Before, immediately after, and 10 minutes after the squatting exercise protocol
Secondary Outcomes (1)
Resting Energy Expenditure
Measured immediately upon arriving to the laboratory. Lasted approximately 25 minutes.
Other Outcomes (3)
Neurological Function
Measured immediately after the resting energy expenditure measurement, and before the other questionnaires. Lasted approximately 15 minutes.
Health and Activity Questionnaire
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.
Fatigue/Depression Assessment
Collected at the same time as the other questionnaires. Lasted approximately 5-7 minutes.
Study Arms (3)
Blood Lactate Response in PD
EXPERIMENTALThis 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.
Blood Lactate Response in MS
EXPERIMENTALThis 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.
Blood Lactate Responses in Controls
EXPERIMENTALThis 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- Parkinson's Disease Stage I-IV (be standard criteria H\&Y scale)
- Multiple Sclerosis
- Healthy, age-matched controls
- to 90 years old
You may not qualify if:
- Dementia
- Co-morbid neurologic factors
- Individuals without independent ambulation
- Significant heart and respiratory disease
- Debilitating arthritis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Fitness and Wellness Center
Tallahassee, Florida, 32306, United States
Balance Disorders Clinic
Tallahassee, Florida, 32308, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michael J. Ormsbee
- Organization
- Florida State University
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J Ormsbee, Ph.D.
Florida State University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 2, 2014
First Posted
July 9, 2014
Study Start
August 1, 2014
Primary Completion
November 1, 2014
Study Completion
December 1, 2014
Last Updated
March 30, 2017
Results First Posted
November 16, 2015
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
If, and when requested, participants may review findings by contacting the PI. Other than participants, only investigators will have access to the data.