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Exercise Study Testing Enhanced Energetics of Mitochondria Video Integrated Delivery of Activity Training in CKD (ESTEEM-VIDA)

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ClinicalTrials.gov Identifier: NCT02923063
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : April 14, 2022
Information provided by (Responsible Party):
University of California, Davis

Brief 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.

Condition or disease Intervention/treatment Phase
Moderate-severe Chronic Kidney Disease Not Treated With Dialysis Diabetic Kidney Disease, HgbA1c Less Than 8.5 Behavioral: Combined Aerobic and Resistance Exercise via videoconferencing Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Trial of Personalized, Home-based Exercise Training on Muscle Mitochondrial Function and Metabolism
Actual Study Start Date : January 16, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Combined Aerobic and Resistance Exercise
Exercise 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.
Behavioral: Combined Aerobic and Resistance Exercise via videoconferencing
Combined aerobic and resistance exercise session thrice weekly for 12 weeks

No Intervention: Usual Care
The 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).

Primary Outcome Measures :
  1. Mitochondrial phosphorylation capacity (ATPmax) by in-vivo 31P MRS [ Time Frame: 12 weeks ]
    leg muscles

  2. Quadriceps muscle work efficiency [ Time Frame: 12 weeks ]
    Work efficiency calculated by cycler ergometry VO2

Secondary Outcome Measures :
  1. Change in physical performance [ Time Frame: 12 weeks ]
    6 minute walking distance (meters)

  2. Change in Systemic oxidative stress (markers of arachidonic acid peroxidation) [ Time Frame: 12 weeks ]
    Plasma isofurans (pg/min)

  3. Change in aerobic capacity (VO2max) (ml/kg/min) [ Time Frame: 12 weeks ]
  4. Monocyte bioenergetics [ Time Frame: 12 weeks ]
    Reserve Capacity (pmole/min/mcg protein)

  5. Total work [ Time Frame: 12 weeks ]
    Total work performed on cycle ergometer (kilojoules)

  6. Muscle mitochondrial reactive oxygen species production from muscle tissue. [ Time Frame: 12 weeks ]
    ratio of hydrogen peroxide (H2O2) production (pmol/min/mg tissue) to oxygen consumption (pmol/min/mg protein)

  7. Muscle mitochondrial oxidative phosphorylation capacity. [ Time Frame: 12 weeks ]
    maximum oxygen consumption production (pmol O2/min/mg tissue) to oxygen consumption (pmol/min/mg protein)

  8. Self-reported fatigue (NIH PROMIS Fatigue) [ Time Frame: 12 weeks ]
    self reported fatigue

  9. Self-reported physical function (PROMIS mobility) [ Time Frame: 12 weeks ]
    self reported difficulty with mobility

  10. MoCA test (cognitive testing) [ Time Frame: 12 weeks ]
    self-reported cognitive testing

  11. Connor-Davidson Resilience Scale 25 (CD-RISC-25) [ Time Frame: 12 weeks ]
    self-reported cognitive testing (depression)

  12. Health Questionnaire [ Time Frame: 12 weeks ]
    self-reported personal health history

  13. FACIT fatigue scale (Version 4) [ Time Frame: 12 weeks ]
    self-reported fatigue scale

  14. Physical Activity Questionnaire (HAP) [ Time Frame: 12 weeks ]
    self reported activity

  15. Lubben Social Network Scale [ Time Frame: 12 weeks ]
    self-reported social engagement questionnaire

  16. Pittsburgh Fatigability Scale [ Time Frame: 12 weeks ]
    self-reported fatigability

  17. Self-Efficacy for Managing Chronic Conditions (PROMIS Bank) [ Time Frame: 12 weeks ]
    self-reported Managing Symptoms, Managing Emotions, Managing Medications and Treatment, Managing Social Interactions, Managing Daily Activities, Cognitive Function, and Profile

  18. Kidney Disease and Quality of Life (KDQOL-SF™ 1.3) [ Time Frame: 12 weeks ]
    self-reported kidney health

  19. Perceived Stress (NIH) [ Time Frame: 12 weeks ]
    self reported perceived stress

Other Outcome Measures:
  1. Walking economy during 6 minute walk [ Time Frame: 12 weeks ]
    Assessement of energetic cost of walking during a submaximal 6 minute walk test using COSMED

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923063

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Contact: Baback Roshanravan, MD MS MSPH 5307540893 broshanr@ucdavis.edu

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United States, California
UC Davis Health Recruiting
Sacramento, California, United States, 98104
Contact: Bob Roshanravan, MD MS MSPH    530-754-0893    broshanr@ucdavis.edu   
Principal Investigator: Baback Roshanravan, MD MS         
Principal Investigator: Javier Lopez, MD         
Sub-Investigator: Erik Henricson, PhD         
Sponsors and Collaborators
University of California, Davis
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Principal Investigator: Baback Roshanravan, MD MS MSPH UC Davis
Principal Investigator: Javier Lopez, MD UC Davis Department of Medicine/Division of Cardiology
Additional Information:
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02923063    
Other Study ID Numbers: 1343904
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: April 14, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, Davis:
Chronic Kidney Disease
Mitochondrial Metabolism
Physical Performance
Exercise Intolerance
Muscle Fatigue
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Diabetic Nephropathies
Urologic Diseases
Renal Insufficiency
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases