Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT01990495
Eligibility Criteria:
Inclusion Criteria:
* Males and females aged 55-80 years undergoing maintenance hemodialysis (MHD) for at least three months and without other active/uncontrolled disease will be studied.
* Exercise and usual care groups will be matched by age, body mass index (BMI), MHD duration, and protein intake using a stratified randomization approach.
* Subjects will be required to be in the peak VO2 range of 10 to 20 ml/kg/min, equivalent to moderate functional impairment in patients with heart failure.
* Subjects will be required to have dialysis treatment for \>3 months with an average Kt/V 1.2, and be able to perform exercise safely.
Exclusion Criteria:
* Current activity \> 2 hrs/wk of moderate intensity exercise, temporary vascular access, uncontrolled diabetes mellitus, active vasculitis, active autoimmune disease, malignancy, severe obesity (BMI \> 35), alcoholism or other recreational drug use, unstable cardiac disease (abnormal exercise test, angina, uncontrolled arrhythmias or myocardial infarction within three months), peripheral vascular disease (claudication with exercise), lung, liver or intestinal disease, those who are medically unstable and subjects who have received anabolic, catabolic or cytotoxic medications in the past 3 months.
* The investigators will also exclude subjects with excessive previous exposure to radiation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
80 Years
Study:
NCT01990495
Study Brief:
Protocol Section:
NCT01990495