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Exercise Program for Chronic Kidney Disease (ESTEEM-VIDA Trial)
ESTEEM-VIDA Trial Summary
This trial is studying how well a combined resistance training and aerobic exercise program works compared to a health education program in improving physical function in people with kidney dysfunction.
ESTEEM-VIDA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowESTEEM-VIDA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ESTEEM-VIDA Trial Design
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Who is running the clinical trial?
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- Currently using drugs or alcohol excessively.I am on long-term dialysis.I am not taking high doses of Vitamin C or E.Your blood pressure is very high before starting the study.My diabetes is not under control, with HgbA1c over 8.5.You regularly take opioids for long-term pain.If the ECG test during exercise shows signs of heart problems, you will be sent to your regular doctor for further evaluation.My kidney function is reduced, with an eGFR under 60.I have never been on long-term dialysis.I am between 30 and 75 years old.I am not currently pregnant.I am taking blood thinners.I do not speak English.I meet other specific requirements not listed here.You have implants that prevent MRI scans or have had an injury with metal pieces in your body.You have had an organ transplant in the past or currently have one.You are expected to start kidney dialysis within the next 6 months.I am not taking medication that affects my cell's energy factories.I am not living in an institution.I use a wheelchair or have a disability that stops me from exercising.I need oxygen therapy for my COPD.I get short of breath walking less than 100 steps on flat ground.I have HIV or hepatitis.My liver is severely damaged and cannot function properly.You have a pacemaker.You weigh more than 300 pounds.I regularly take medication to suppress my immune system.People who do exercise once a week are not included.I have a history of clotting or bleeding disorders.I have a history of severe heart disease, including CABG surgery or atrial fibrillation.Your hemoglobin level is less than 9 grams per deciliter.I have a vascular stent placed within the last 6 months.You are currently using illegal drugs like amphetamines.You don't exercise regularly, except if you bike to work more than once a week or walk for leisure.My thyroid condition is currently not under control.I have an active cancer that is not a non-melanoma skin cancer.
- Group 1: Combined Aerobic and Resistance Exercise
- Group 2: Usual Care
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the numerical scope of enrollment for this medical research project?
"Yes, according to clinicaltrials.gov, this research project is currently looking for participants. Its initial post date was January 16th 2020 with the latest update occurring on April 7th 2022. 45 patients are needed from a single location for enrollment in the study."
Are there any vacancies left in this research study for participants?
"Clinicialtrials.gov states that the recruitment process for this study is still ongoing, having first started on January 16th 2020 and being updated most recently on April 7th 2022."
Are individuals aged 25 and over eligible to participate in this experiment?
"This medical research is recruiting patients between the ages of 30 and 75."
What are the fundamental aims of this experiment?
"Over the course of 12 weeks, trial participants' Quadriceps muscle work efficiency will be monitored and assessed as the primary outcome. As secondary outcomes, researchers have selected Lubben Social Network Scale (a self-reported social engagement survey), Total Work (total kilojoules performed on a cycle ergometer), and Kidney Disease and Quality of Life (KDQOL-SF™ 1.3; a self-reported kidney health questionnaire)."
Am I eligible to be a participant in this investigation?
"This trial seeks 45 volunteers with diabetic kidney disease, hgba1c below 8.5, and aged between 30 to 75 years old that must meet the following conditions: moderate-severe CKD as judged by eGFR <60ml/min per 1.73m2, no history of chronic dialysis treatment, self-reported limited amounts of structured endurance exercise (EE) or resistance exercise (RE), perceived increased heart rate or rapid breathing during EE sessions leading to sweating and muscular fatigue experienced in RE activities lasting up to 60 minutes within a year prior to study entry; persons using biking for transportation purposes on more than one day"
Has the FDA sanctioned Combined Aerobic and Resistance Exercise via videoconferencing for use in clinical settings?
"The safety of Combined Aerobic and Resistance Exercise through videoconferencing has been deemed a 2 due to the lack of empirical evidence regarding efficacy, but some data exists in regards to safety."
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