An Exercise Study Testing Muscle Mitochondria (energy production) in Chronic Kidney Disease: ESTEEM

ESTEEM Study Description

The purpose of this research study is to find out if exercise improves how well the mitochondria work. We also want to know if exercise improves ability to perform physical tasks. Finally, we will also test several components in the blood which may be related to physical abilities. We are doing this research because exercise may improve the overall balance of these components. What we learn in this study may help us to better understand the mitochondria and muscle in people with kidney disease. We hope to use this knowledge to improve their ability to be active and independent.

This Study Requires

The study doctor or study coordinator will see you for study visits at the UC Davis Medical Center – either the Ambulatory Care Center (ACC) and/or the Imaging Research Center (IRC) depending on the visit. Each participant will undergo a Screening/Enrollment, two ACC (pre- and post-intervention), and two ACC/IRC (pre- and post-intervention) visits. See the study schedule on the last page of this form for an overview.

There will be 2 study groups. We will assign some subjects to just keep getting their usual care. We will assign the other subjects to a 12-week program of exercise. At the end of the study, we will compare muscle metabolism and muscle function in subjects who were and were not assigned to the exercise program. The treatment you get will be chosen by chance, like flipping a coin. Neither you nor the study doctor will choose what treatment you get. You will have a one in four chance of being given each treatment.

Eligibility Criteria

In order to participate in this study you must be an adult US Citizen living within 30 miles of Sacramento, CA.

Who can participate

Inclusion criteria:

  • Moderate-severe CKD determined by estimated glomerular filtration rate (eGFR) <50ml/min per 1.73m2
  • No history chronic treatment with dialysis.
  • Age 18 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

Exclusion criteria:

  • Current or previous transplantation
  • Current pregnancy
  • Wheelchair dependence
  • 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
  • Liver 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
  • Vascular stent: bare metal or any recently placed (within 6 months)
  • Current substance abuse
  • Institutionalization
  • Current participation in an interventional trial
  • Inability to provide informed consent without a proxy respondent
  • Non-English speaking
  • Any condition which in the judgement of the clinical investigator places the participant at risk from participation in the study. Additional Criteria:
  • On chronic dialysis
  • Expectation to start dialysis within 6 months.
  • Insulin dependent diabetes
  • Baseline systolic blood pressure >170 or diastolic blood pressure >100

Benefits and risks of participating

BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.

RISKS:

The study doctor will discuss the risks associated with taking part in this research study.CompensationWe will pay you $20 if you do not qualify for the study after completion of Pre-Intervention Visit 1. Exercisers that have completed all requirements of the ESTEEM study including both biopsies will receive a total of $300. Payment will be provided at the ending points as described above. If you choose to leave or we take you off the study for any reason, you will receive the amount for whichever stage you last completed.

Resources
Study IDUC Davis IRB: 1343904

ClinicalTrials.gov: NCT02923063

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.

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