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Moderate-severe Chronic Kidney Disease Not Treated With DialysisESTEEM-VIDANCT02923063

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

A study testing Combined Aerobic and Resistance Exercise via videoconferencing in people with Moderate-severe Chronic Kidney Disease Not Treated With Dialysis and Diabetic Kidney Disease, HgbA1c Less Than 8.5, run by University of California, Davis at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Skeletal muscle dysfunction (sarcopenia) is an under-recognized target organ complication of CKD with substantial adverse clinical consequences of disability, hospitalization, and death. Read more about this study

Who is it for?
Ages 30 to 75 years
What is being tested?
Combined Aerobic and Resistance Exercise via videoconferencing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
16 Jan 2020to 11 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 42Show fewer
  • 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
  • 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.
  • High dose antioxidants (Vitamine C, Vitamin E)
  • Baseline systolic blood pressure >170 or diastolic blood pressure >100
  • Uncontrolled diabetes with a HgbA1c >8.5
  • Active uncontrolled thyroid disease
  • Anemia (Hgb <9 g/dL)
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UC Davis Health

    Sacramento, California, 98104

Other trials in United States

About this study

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

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.

Read the detailed description

Sarcopenia is a common complication of chronic kidney disease. Sarcopenia is defined by decreased muscle mass or function and is central to the frailty phenotype that is associated disability, hospitalization, and death. Sarcopenia is a common and devastating complication of chronic kidney disease (CKD). The investigators and others have demonstrated a high prevalence of physical frailty among CKD patients not treated with dialysis. Furthermore the investigators have demonstrated greater than 30% impairment in lower extremity physical performance measures in persons with CKD compared with predicted values. The aging demographic among CKD patients will result in a substantial U.S. public health burden attributable to sarcopenia. In the year 2000, direct healthcare costs attributable to sarcopenia in the U.S. were18.5 billion.

Sarcopenia is associated with adverse health-related outcomes. Sarcopenia in older adults is consistently linked with decreased physical functioning, disability, falls, hospitalization, and mortality. Impaired lower extremity physical performance, as measured by objective testing, is associated with all-cause mortality in CKD patients not treated with dialysis and that these associations are stronger in magnitude than those for traditional risk factors. Skeletal muscle is major site of peripheral glucose utilization ameliorating oxidative stress and endothelial injury associated with acute post-prandial hyperglycemia. Through these mechanisms sarcopenia may contribute to metabolic disturbances of insulin resistance, oxidative stress, and endothelial dysfunction leading to cardiovascular disease.

Mitochondrial dysfunction is central to skeletal muscle dysfunction. Skeletal muscle mitochondria are necessary for the efficient generation of energy (ATP) from oxygen and normal lipid metabolism. Under normal conditions, muscle efficiently utilizes the majority of supplied oxygen such that only 0.2% of mitochondrial oxygen is shuttled into reactive oxidative species (ROS). Under pathologic situations there is uncoupling of oxygen consumption and ATP generation resulting in increased oxygen consumption and decreased ATP production in a process leading to increased ROS and oxidative stress. Uncoupling of oxygen and ATP generation directly affects skeletal muscle function. Decreased efficiency of ATP generation has been linked to decreased muscle strength and more recently associated with decreased gait speed in older adults.

Magnetic resonance spectroscopy and optical spectroscopy (MRS/OS) provide novel, non-invasive and real-time insight into human skeletal muscle mitochondrial function. MRS/OS is a novel technique that measures maximal mitochondrial ATP production in-vivo following acute bouts of ischemia induced by exercise using phosphorous MRS (31P MRS). The rate of recovery of phosphocreatinine after cessation of exercise is used to characterize the rate of aerobic mitochondrial ATP resynthesis above that of basal anaerobic glycolytic ATP production. By combining this technique with optical spectroscopy post-exercise measuring the transport of oxygen from hemoglobin to myoglobin within the muscle the investigators are able to accurately determine the ratio of coupling efficiency between of ATP generation per unit of oxygen consumption. Skeletal muscle mitochondrial dysfunction measured by ATP generating capacity and coupling efficiency has been associated with processes of aging and insulin resistance. Furthermore studies in healthy subjects have shown that muscle performance and fatigue are linked to the ability to resynthesize ATP rather than lactate concentration.

Preliminary MRS/OS findings suggest profoundly altered mitochondrial function in CKD patients. Previous experimental studies suggest that uremia in dialysis patients affects skeletal muscle structure and mitochondrial function. Oxidative damage is highly prevalent in CKD, evidenced by increased biomarkers of oxidative stress and changes in glutathione, an important antioxidant. Prior small studies in non-diabetic CKD patients suggest impairment of ex-vivo mitochondrial function by reductions in mitochondrial enzyme activity. Based on these findings investigators used novel, non-invasive, functional MRS/OS assay to characterize in-vivo mitochondrial function. Preliminary findings in non-diabetic CKD patients indicate markedly reduced ATP to oxygen ratio compared to controls. This finding suggests altered mitochondrial energetics as a candidate central mechanism linking metabolic derangements and impaired physical function in CKD, and motivate the hypothesis that mitochondrial dysfunction is associated with oxidative stress, insulin resistance and impaired physical functioning in CKD.

Exercise may ameliorate mitochondrial dysfunction, insulin resistance and physical functioning in CKD. Studies of exercise in non-CKD patients with diabetes and insulin resistance have demonstrated exercise-induced improvements in mitochondrial biogenesis linked to improved insulin sensitivity as well as decreased mitochondrial oxidative stress. Animal studies suggest that exercise stimulates autophagy resulting in removal of defective and inefficient mitochondrial leading to a healthy mitochondrial network and improved insulin sensitivity.The primary goal of this study is to investigate the impact of combined resistance and aerobic exercise on skeletal muscle dysfunction. Given the investigator's preliminary data demonstrating strong association of sarcopenia and mortality in CKD, effective interventions that can impact physical function are urgently needed to improve patient health outcomes.

Being tested
Combined Aerobic and Resistance Exercise via videoconferencing
Keywords
Chronic Kidney Disease, Mitochondrial Metabolism, Physical Performance, Exercise Intolerance, Muscle Fatigue
Medical subject headings
Diabetic Nephropathies, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined Aerobic and Resistance Exercise via videoconferencingBehavioural

    Combined aerobic and resistance exercise session thrice weekly for 12 weeks

Study groups in NCT02923063
Study groupRoleWhat they receive
Combined Aerobic and Resistance ExerciseExperimentalExercise will be supervised by exercise trainers 3 days per week for 12 weeks via videoconferencing. Each session will start at 30 minutes in duration and include either high-intensity interval targeting a relative perceived exertion (RPE) of greater than 14 (on a scale of 6-20) or strength training (RPE 12-14) or power walking (RPE 12-14). Each 1 week of supervised sessions will alternate with 1 week of self-directed sessions with mid-week trainer check-in.
Receives: Behavioral: Combined Aerobic and Resistance Exercise via videoconferencing
Usual CareNo interventionThe control group will receive a one-time counseling session on appropriate dietary and physical activity recommendations. They will receive a "Go4Life Workout to go" sample exercise routing created by the national institutes on aging (NIA).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mitochondrial phosphorylation capacity (ATPmax) by in-vivo 31P MRS

    leg muscles

    Measured: 12 weeks

  2. Quadriceps muscle work efficiency

    Work efficiency calculated by cycler ergometry VO2

    Measured: 12 weeks

Secondary outcomes (19)
  1. Change in physical performance

    6 minute walking distance (meters)

    Measured: 12 weeks

  2. Change in Systemic oxidative stress (markers of arachidonic acid peroxidation)

    Plasma isofurans (pg/min)

    Measured: 12 weeks

  3. Change in aerobic capacity (VO2max) (ml/kg/min)

    Measured: 12 weeks

  4. Monocyte bioenergetics

    Reserve Capacity (pmole/min/mcg protein)

    Measured: 12 weeks

  5. Total work

    Total work performed on cycle ergometer (kilojoules)

    Measured: 12 weeks

  6. Muscle mitochondrial reactive oxygen species production from muscle tissue.

    ratio of hydrogen peroxide (H2O2) production (pmol/min/mg tissue) to oxygen consumption (pmol/min/mg protein)

    Measured: 12 weeks

  7. Muscle mitochondrial oxidative phosphorylation capacity.

    maximum oxygen consumption production (pmol O2/min/mg tissue) to oxygen consumption (pmol/min/mg protein)

    Measured: 12 weeks

  8. Self-reported fatigue (NIH PROMIS Fatigue)

    self reported fatigue

    Measured: 12 weeks

  9. Self-reported physical function (PROMIS mobility)

    self reported difficulty with mobility

    Measured: 12 weeks

  10. MoCA test (cognitive testing)

    self-reported cognitive testing

    Measured: 12 weeks

  11. Connor-Davidson Resilience Scale 25 (CD-RISC-25)

    self-reported cognitive testing (depression)

    Measured: 12 weeks

  12. Health Questionnaire

    self-reported personal health history

    Measured: 12 weeks

  13. FACIT fatigue scale (Version 4)

    self-reported fatigue scale

    Measured: 12 weeks

  14. Physical Activity Questionnaire (HAP)

    self reported activity

    Measured: 12 weeks

  15. Lubben Social Network Scale

    self-reported social engagement questionnaire

    Measured: 12 weeks

  16. Pittsburgh Fatigability Scale

    self-reported fatigability

    Measured: 12 weeks

  17. Self-Efficacy for Managing Chronic Conditions (PROMIS Bank)

    self-reported Managing Symptoms, Managing Emotions, Managing Medications and Treatment, Managing Social Interactions, Managing Daily Activities, Cognitive Function, and Profile

    Measured: 12 weeks

  18. Kidney Disease and Quality of Life (KDQOL-SF™ 1.3)

    self-reported kidney health

    Measured: 12 weeks

  19. Perceived Stress (NIH)

    self reported perceived stress

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2016 (estimated)
  2. Study start16 Jan 2020
  3. Primary completion2 Oct 2024
  4. Study completion11 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02923063
Sponsor's protocol ID
1343904
Acronym
ESTEEM-VIDA
Status last verified
Feb 2026
First submitted
29 Sep 2016
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Combined Aerobic and Resistance Exercise via videoconferencing in people with Moderate-severe Chronic Kidney Disease Not Treated With Dialysis and Diabetic Kidney Disease, HgbA1c Less Than 8.5, run by University of California, Davis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mitochondrial phosphorylation capacity (ATPmax) by in-vivo 31P MRS (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.

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