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

Study Overview
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Brief Summary
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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.

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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Dietary Supplement: Ketone Ester Beverage
* Dietary Supplement: Electrolyte Beverage
* Behavioral: Cycling Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketone Ester Beverage & Exercise<br>Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C6-KE) of Juvenescence Metabolic Switch ™ and electrolyte solution diluted in water, before each of 5 1-hour sessions of aerobic exercise. | Dietary Supplement: Ketone Ester Beverage<br>* Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C6-KE) of Juvenescence Metabolic Switch ™ and electrolyte solution diluted in water, before each of 5 1-hour sessions of aerobic exercise.<br>* Other names: Juvenescence Metabolic Switch™;Behavioral: Cycling Intervention<br>* 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.<br>|
| Placebo Comparator: Electrolyte Beverage & Exercise<br>Participants will consume placebo electrolyte (EL) beverage, consisting of an electrolyte solution diluted in water, before each of 5 1-hour sessions of aerobic exercise | Dietary Supplement: Electrolyte Beverage<br>* Participants will consume an electrolyte solution diluted in water, before each of 5 1-hour sessions of aerobic exercise.<br>Behavioral: Cycling Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change in One-minute Anaerobic Threshold Test Cadence | Participants will then engage in a 1-min anaerobic threshold test. Participants will be instructed to cycle at as high a cadence as possible at the ergometer resistance that achieves their personalized target wattage (calculated from baseline test) when cycling at 80 rpm. Change in cadence will be calculated by subtracting cadence at baseline from cadence at follow-up. | After approximately 2-weeks of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Ketone Ester, Keto