Effects of Exercise Training and Ketone Ester on Muscle Strength and Cardiovascular Response in Parkinson's Disease

University of Michigan19 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Parkinson Disease

Interventions

Ketone Ester BeverageDIETARY_SUPPLEMENT

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.

Electrolyte BeverageDIETARY_SUPPLEMENT

Participants will consume an electrolyte solution diluted in water, before each of 5 or 12 1-hour sessions of aerobic exercise.

Cycling InterventionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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.)

Locations (1)

Domino's Farms

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Change in Duration of 80 Rpm Endurance Test

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.

Time frame: After approximately 2 weeks of intervention

Change in Oxygen Uptake (VO2 Max)

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.

Time frame: After approximately 2 weeks of intervention

Data from ClinicalTrials.gov

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