Exercise Study Testing Enhanced Energetics of Mitochondria Video Integrated Delivery of Activity … (NCT02923063) | Clinical Trial Compass
CompletedNot Applicable
Exercise Study Testing Enhanced Energetics of Mitochondria Video Integrated Delivery of Activity Training in CKD
United States32 participantsStarted 2020-01-16
Plain-language summary
Skeletal muscle dysfunction (sarcopenia) is an under-recognized target organ complication of CKD with substantial adverse clinical consequences of disability, hospitalization, and death. Sarcopenia in this proposal is defined by impaired metabolism and physical function associated with decreased skeletal muscle mass or function. Skeletal muscle tissue relies on mitochondria to efficiently utilize oxygen to generate ATP. Impaired mitochondrial energetics is a central mechanism of sarcopenia in CKD. The investigators propose a series of studies designed to shed light on the pathophysiology of sarcopenia in persons with CKD not treated with dialysis. Investigators will conduct a randomized-controlled intervention trial of combined resistance training and aerobic exercise vs. health education to assess changes in skeletal muscle mitochondrial function, metabolism and physical function. Investigators hypothesize that exercise improves mitochondrial function and physical function in persons with CKD. If successful, these experiments will identify novel pathophysiologic mechanisms for CKD-associated sarcopenia. The proposed study will provide useful insight into benefits associated with exercise among patients with CKD and investigate mechanisms associated with improved metabolism, muscle function and physical function in population.
Who can participate
Age range
30 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Moderate-severe CKD determined by estimated glomerular filtration rate (eGFR) \<60ml/min per 1.73m2
* No history chronic treatment with dialysis.
* Age 30 years old to 75 years
* Sedentary defined as self-reporting no more than 1 day per week of regular (structured) endurance exercise (EE) \[e.g., brisk walking, jogging/running, cycling, elliptical, or swimming activity that results in feelings of increased heart rate or rapid breathing (EE), and/or sweating\] or resistance exercise (RE) (resulting in muscular fatigue) lasting no more than 60 minutes in the past year.
* Persons bicycling as a mode of transportation to/from work \> 1 day/week etc. are not considered sedentary
* Leisure walkers are included unless they meet the heart rate, breathing and sweating criteria noted above
* Persons adherent to both 1 day/week of RE and 1 day/week of EE are excluded
Exclusion Criteria:
* Current or previous transplantation
* Current pregnancy (all females of child-bearing potential will have a pregnancy test)
* Wheelchair dependence or other disability that precludes physical exercise
* Oxygen dependent Chronic obstructive pulmonary disease (COPD)
* Shortness of breath after walking \<100 steps on flat surface
* Weight \>300 pounds
* HIV infection or hepatitis viral infection
* Decompensated cirrhosis
* Active malignant cancer other than non-melanomatous skin cancer
* Drugs that alter mitochondrial function:
* muscle relaxants (methocarbamol, baclofe…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mitochondrial phosphorylation capacity (ATPmax) by in-vivo 31P MRS