Effects of Combined Exercise Training and Ketone Ester on Muscle Strength and Cardiovascular Response in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Change in duration of 80 rpm endurance test
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's Disease
排除标准
- •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.)
研究组 & 干预措施
5-Session Ketone Ester Beverage & Exercise
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 1-hour sessions of aerobic exercise.
干预措施: Ketone Ester Beverage (Dietary Supplement)
5-Session Ketone Ester Beverage & Exercise
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 1-hour sessions of aerobic exercise.
干预措施: Cycling Intervention (Behavioral)
5-Session Electrolyte Beverage & Exercise
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
干预措施: Electrolyte Beverage (Dietary Supplement)
5-Session Electrolyte Beverage & Exercise
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
干预措施: Cycling Intervention (Behavioral)
12-Session Ketone Ester Beverage & Exercise
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 12 1-hour sessions of aerobic exercise.
干预措施: Ketone Ester Beverage (Dietary Supplement)
12-Session Ketone Ester Beverage & Exercise
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 12 1-hour sessions of aerobic exercise.
干预措施: Cycling Intervention (Behavioral)
12-Session Electrolyte Beverage & Exercise
Participants will consume placebo electrolyte (EL) beverage, consisting of an electrolyte solution diluted in water, before each of 12 1-hour sessions of aerobic exercise
干预措施: Electrolyte Beverage (Dietary Supplement)
12-Session Electrolyte Beverage & Exercise
Participants will consume placebo electrolyte (EL) beverage, consisting of an electrolyte solution diluted in water, before each of 12 1-hour sessions of aerobic exercise
干预措施: Cycling Intervention (Behavioral)
结局指标
主要结局
Change in duration of 80 rpm endurance test
时间窗: After approximately 2-6 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.
Change in oxygen uptake (VO2 max)
时间窗: After approximately 2-6 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.
Change in Duration of 80 Rpm Endurance Test
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点
研究者
Chatkaew Pongmala
Research Investigator
University of Michigan