Skip to main content
OpenTrials
Completed

NCT Number: NCT05948956

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Motor Activity Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Domino's Farms

Ann Arbor, Michigan, 48105, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Ketone Ester Beverage

Dietary 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.

Other names: Qitone Pro-ketone Powder ™

Electrolyte Beverage

Dietary Supplement

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

Cycling Intervention

Behavioral

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.

Primary outcomes

  1. Change in Duration of 80 Rpm Endurance Test

    Time frame: 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.

  2. Change in Oxygen Uptake (VO2 Max)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Acronym: CYCLE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2023
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.