Blood Lactate Concentrations With and Without Exercise in Parkinson's
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
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- pro5 AIRdaptive Power Plate (Badhoevedorp, The Netherlands)
Results by group
Blood Lactate Response
Before, immediately after, and 10 minutes after the squatting exercise protocol
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Blood Lactate Response in PD | 1.7 mmol/L | 0.7 (Standard Deviation) | 12 |
| Blood Lactate Response in MS | 1.6 mmol/L | 0.7 (Standard Deviation) | 11 |
| Blood Lactate Responses in Healthy, Older Adults | 1.2 mmol/L | 0.4 (Standard Deviation) | 6 |
| Blood Lactate Response in PD | 2.3 mmol/L | 0.9 (Standard Deviation) | 12 |
| Blood Lactate Response in MS | 2.8 mmol/L | 1.3 (Standard Deviation) | 11 |
| Blood Lactate Responses in Healthy, Older Adults | 2.5 mmol/L | 1.1 (Standard Deviation) | 6 |
| Blood Lactate Response in PD | 2.2 mmol/L | 1.3 (Standard Deviation) | 12 |
| Blood Lactate Response in MS | 3.3 mmol/L | 2.3 (Standard Deviation) | 11 |
| Blood Lactate Responses in Healthy, Older Adults | 2.6 mmol/L | 1.2 (Standard Deviation) | 6 |
| Blood Lactate Response in PD | 1.8 mmol/L | 0.7 (Standard Deviation) | 12 |
| Blood Lactate Response in MS | 2.2 mmol/L | 1 (Standard Deviation) | 11 |
| Blood Lactate Responses in Healthy, Older Adults | 1.3 mmol/L | 0.3 (Standard Deviation) | 6 |
| Blood Lactate Response in PD | 3.1 mmol/L | 2.4 (Standard Deviation) | 12 |
| Blood Lactate Response in MS | 4.3 mmol/L | 3 (Standard Deviation) | 11 |
| Blood Lactate Responses in Healthy, Older Adults | 2.9 mmol/L | 0.9 (Standard Deviation) | 6 |
| Blood Lactate Response in PD | 1.8 mmol/L | 0.5 (Standard Deviation) | 12 |
| Blood Lactate Response in MS | 3.1 mmol/L | 1.9 (Standard Deviation) | 11 |
| Blood Lactate Responses in Healthy, Older Adults | 2.2 mmol/L | 0.9 (Standard Deviation) | 6 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Blood Lactate Response in PD | 12 | 0 (0.0%) | |
| Blood Lactate Response in MS | 11 | 0 (0.0%) | |
| Blood Lactate Responses in Healthy, Older Adults | 8 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Blood Lactate Response
Before, immediately after, and 10 minutes after the squatting exercise protocol
Physical function
Other measures (1)
Resting Energy Expenditure
Measured immediately upon arriving to the laboratory. Lasted approximately 25 minutes.
Who could take part
MS (type not specified) · 45 to 90
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Aug 2014
Main results due
Nov 2014
Finished
Dec 2014
Results posted
Nov 2015