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NCT02923063Completed

Exercise Study Testing Enhanced Energetics of Mitochondria Video Integrated Delivery of Activity Training in CKD

A Randomized, Controlled Trial of Personalized, Home-based Exercise Training on Muscle Mitochondrial Function and Metabolism

Source: ClinicalTrials.gov · Last updated 10 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
32 (actual)
First submitted
29 Sept 2016
Start date
16 Jan 2020
Primary completion date
2 Oct 2024
Lead sponsor
University of California, Davis
NCT number
NCT02923063

What you commit to

  • Study type: Interventional
  • Participants enrolled: 32
  • From 16 Jan 2020 to the primary completion date, 2 Oct 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current or previous transplantation
  • 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

Other illness

  • Oxygen dependent Chronic obstructive pulmonary disease (COPD)
  • HIV infection or hepatitis viral infection
  • Active malignant cancer other than non-melanomatous skin cancer
  • 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
  • Any condition which in the judgement of the clinical investigator places the participant at risk from participation in the study.
    • Additional Criteria:
  • Uncontrolled diabetes with a HgbA1c \>8.5
  • Active uncontrolled thyroid disease

Lab values

  • Anemia (Hgb \<9 g/dL)

Other

  • Current pregnancy (all females of child-bearing potential will have a pregnancy test)
  • Wheelchair dependence or other disability that precludes physical exercise
  • Shortness of breath after walking \<100 steps on flat surface
  • Weight \>300 pounds
  • Decompensated cirrhosis
  • 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
  • On chronic dialysis
  • Expectation to start dialysis within 6 months.
  • High dose antioxidants (Vitamine C, Vitamin E)
  • Baseline systolic blood pressure \>170 or diastolic blood pressure \>100
  • Current substance abuse (i.e. amphetamine abuse)
  • Chronic opioid use (i.e. for chronic pain)
  • Chronic use of immunosuppressants
  • Active coronary ischemia detected by ECG on cycle ergometry VO2max testing. These individuals will be promptly referred to their primary care provider by the PI.

Who the study is looking for

  • 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

Age in the registry: 30 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UC Davis Health
Coordinator of this site? Confirm its status
SacramentoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.