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

Parkinson Disease Clinical Trial

— CYCLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05948956
• Other study ID #: HUM00232413
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2023
• Est. completion date: January 2025

Study information

• Verified date: January 2024
• Source: University of Michigan
• Contact: Austin Luker, BS
• Phone: 734-936-0111
• Email: aluker[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Dietary Supplement:
• Ketone Ester Beverage
Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C8-KE) of Juvenescence Cognitive Switch ™ and electrolyte solution diluted in water, before each of 5 1-hour sessions of aerobic exercise.
• Electrolyte Beverage
Participants will consume an electrolyte solution diluted in water, before each of 5 1-hour sessions of aerobic exercise.

Behavioral:
• Cycling Intervention
Five 1-hour sessions of cycling on the ergometer over a 2-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.

Locations

Country	Name	City	State
United States	Domino's Farms	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	After approximately 2-weeks of intervention
Primary	Change in isometric quadricep muscle strength	Participants will sit on an ergometer with their knee secured at a 90-degree angle. Participants will be instructed to perform a maximal effort static knee extension against the resistance of the ergometer for up to 5 trials. Isometric quadricep muscle strength will be measured as the mean torque in Newtons exerted on the ergometer by the participant across all trials. Change in strength will be calculated by subtracting the mean torque at baseline from the mean torque at follow up. Greater torque indicates greater isometric quadricep strength.	After approximately 2-weeks of intervention
Primary	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.	After approximately 2-weeks of intervention