Exercise to Prevent Muscle Mass and Functional Loss in Elderly Dialysis Patients

Completed · Not applicable

Conditions studied: Chronic Kidney Disease

In brief

The majority of individuals with advanced ESRD have reduced exercise capacity in part due to decreased muscle mass. This leads to a reduced ability to perform daily activities, a greater incidence of falls, and a reduced quality of life. The mechanisms responsible for the loss of muscle mass in ESRD are not understood very well. This study is designed to determine the effectiveness of an exercise program on improving muscle mass, exercise capacity and quality of life in persons with ESRD. In addition, the study will attempt to better understand why muscle loss occurs in people with ESRD, the influence exercise has on these mechanisms, and whether the response to exercise can be enhanced with nutrient supplementation.

Key facts

Study ID

NCT01990495

Run by

VA Office of Research and Development

People needed

37

Starts

2013-11-01

Expected to finish

2019-09-30

Last updated by the study team

2021-01-25

Who can join

Age: 55 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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