NCT02184494

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

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
12 months until next milestone

Results Posted

Study results publicly available

November 16, 2015

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

July 2, 2014

Results QC Date

July 2, 2015

Last Update Submit

March 7, 2017

Conditions

Keywords

Parkinson's DiseaseMultiple SclerosisFatigueResting Energy ExpenditureWhole Body VibrationExerciseBlood Lactate

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

EXPERIMENTAL

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)

Blood Lactate Response in MS

EXPERIMENTAL

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)

Blood Lactate Responses in Controls

EXPERIMENTAL

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)

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

Blood Lactate Response in MSBlood Lactate Response in PDBlood Lactate Responses in Controls

Eligibility Criteria

Age45 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Balance Disorders Clinic

Tallahassee, Florida, 32308, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseMultiple SclerosisFatigueMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Results Point of Contact

Title
Michael J. Ormsbee
Organization
Florida State University

Study Officials

  • Michael J Ormsbee, Ph.D.

    Florida State University

    PRINCIPAL INVESTIGATOR

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.

Locations