Parkinson Disease
Conditions
Keywords
Exercise, Ketone Ester, Keto
Brief summary
The main purpose of this study is to assess changes in exercise capacity in people with Parkinson's disease before and after an exercise training program with ketone ester supplementation.
Interventions
DIETARY_SUPPLEMENTKetone Ester Beverage
Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C8-KE) of Qitone Pro-ketone Powder ™ and electrolyte solution diluted in water, before each of 5 or 12 1-hour sessions of aerobic exercise.
DIETARY_SUPPLEMENTElectrolyte Beverage
Participants will consume an electrolyte solution diluted in water, before each of 5 or 12 1-hour sessions of aerobic exercise.
BEHAVIORALCycling Intervention
Five or twelve 1-hour sessions of cycling on the ergometer over a 2-6 week period. Sessions will consist of a 10 min warm up followed by 8 intervals consisting of 3 min "fast" cycling at 80-90 rpm followed by 2 min of "slow" cycling at ≤60rpm, followed by a 10-minute cool-down.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Parkinson's Disease
Exclusion criteria
* Any recent changes in EKG, history of myocardial infarction or other cardiac event or other cardiac contraindications to exercise * Inability to use a step, stand, walk, or use a stationary cycle ergometer * History of symptoms in exercise that preclude safe and comfortable participation, such as dizziness and lightheadedness, orthostasis, severe symptomatic leg or back musculoskeletal pain, painful neuropathy, significant ankle edema or medication side effects * History of symptomatic cardiovascular or pulmonary disease interfering with exercise * History of active rheumatoid arthritis * History of uncontrolled chronic pain syndrome * Any other history of medical or psychiatric comorbidity precluding safe participation in the project * Poorly controlled diabetes * Pregnancy or breastfeeding * Clinically significant dementia * Any contraindications to MRI (metal implants, severe claustrophobia, inability to lie still for 1 hour, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Duration of 80 Rpm Endurance Test | After approximately 2 weeks of intervention | Participants will cycle at their personalized fixed wattage at 80 rpm until failure, defined as the point at which the participant could not sustain a cadence of \>70 rpm for a cumulative total of 20 s, or until voluntarily choosing to end the test. Change in duration will be calculated by subtracting the baseline duration from duration at follow-up. Greater duration indicates better endurance. Measured in minutes. |
| Change in Oxygen Uptake (VO2 Max) | After approximately 2 weeks of intervention | VO2 max (defined as volume of oxygen consumed in mL divided by body weight in kg per minute) will be measured during a controlled cycling session on a stationary bike. Participants will begin at a cadence of 80 rpm at 50 watts for 4 minutes. Thereafter, wattage will increase by 10 watts every 2 minutes until the participant voluntarily ends the session or is no longer able to sustain a cadence of \>70 rpm. Participants will wear a face mask that measures their oxygen intake during the session. Change in VO2 max will be calculated by subtracting the baseline VO2 max from VO2 max at follow-up. Greater VO2 max indicates better cardiorespiratory fitness. VO2 max will be measured after 4 minute period. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChatkaew Pongmala, PhD
University of Michigan
Participant flow
Recruitment details
21 people were recruited for the study. Of those 21, 2 withdrew prior to completing the baseline. The study initially involved a 5-session intervention, which was later extended to a 12-session intervention. All 19 completed the 5-session intervention, while 4 of those 18 completed the 12-session intervention.
Pre-assignment details
Of the 19 participants who started the 5-session intervention, 4 of those continued to complete 12-sessions. The total number of participants that were automatically calculated is inflated due to the 4 participants who participated in both interventions.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous 12 Sessions | 73.25 years STANDARD_DEVIATION 2.63 |
| Age, Continuous 5 Sessions | 67.95 years STANDARD_DEVIATION 6.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 10 | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 6 / 9 | 4 / 10 | 2 / 2 | 1 / 2 |
| serious Total, serious adverse events | 0 / 9 | 0 / 10 | 0 / 2 | 0 / 2 |
Outcome results
None listed