Exercise Study Testing Enhanced Energetics of Mitochondria Video Integrated Delivery of Activity Training in CKD
Completed · Not applicable
Conditions studied: Moderate-severe Chronic Kidney Disease Not Treated With Dialysis, Diabetic Kidney Disease, HgbA1c Less Than 8.5
In brief
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.
Key facts
- Study ID
- NCT02923063
- Run by
- University of California, Davis
- People needed
- 32
- Starts
- 2020-01-16
- Expected to finish
- 2025-09-11
- Last updated by the study team
- 2026-02-10
Who can join
Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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, baclofen, tizanidine, carisoprodol, cyclobenzaprine)
- oral steroids (Equivalent of 10mg or more of prednisone daily)
- anti-viral medications (tenofovir, zalcitabine, didanosine, stavudine, lamivudine, zidovudine, abacavir, adefovir, interferon, ribavirin, efavirenz, dasabuvir, ombitasvir)
- oral calcineurin inhibitors (Tacrolimus, Cyclosporine)
- Antiepileptic drugs (Phenytoin, phenobarbital, carbamazepine, valproic acid, oxcarbazepine, ethosuximide, zonisamide, topiramate, and vigabatrin)
- Antipsychotics (haloperidol, thioridazine, risperidone, quetiapine, clozapine, olanzapine and aripiprazole)
- Drugs- anticoagulants or antiplatelets
- Anticoagulants, any 1 (coumadin, rivaroxaban, apixaban, dabigatran, edoxaban)
- Antiplatelets, any 2 (aspirin, cilostazol, clopidogrel, dipyridamole, prasugrel, ticagrelor, ticlopidine, vorapaxar)
- Implants that prohibit MRI measurements or trauma involving metal fragments
- Pacemaker
- History of clotting disorder (Deep venous thrombosis, pulmonary embolism) or bleeding disorder.
- History of sever heart disease/disorders: coronary artery bypass graft (CABG) surgery, atrial fibrillation
- Vascular stent: bare metal or any recently placed (within 6 months)
- Current substance abuse
Where it is running
- UC Davis Health — Sacramento, California, United States
Full record on ClinicalTrials.gov
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