Exercise Study Testing Enhanced Energetics of Mitochondria Video Integrated Delivery of Activity Training in CKD (ESTEEM-VIDA)
Moderate-severe Chronic Kidney Disease Not Treated With Dialysis, Diabetic Kidney Disease, HgbA1c Less Than 8.5
About this trial
This is an interventional treatment trial for Moderate-severe Chronic Kidney Disease Not Treated With Dialysis focused on measuring Chronic Kidney Disease, Mitochondrial Metabolism, Physical Performance, Exercise Intolerance, Muscle Fatigue
Eligibility Criteria
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.
Sites / Locations
- UC Davis HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Combined Aerobic and Resistance Exercise
Usual Care
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.
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).