COMEX Study for Dialysis Patients

Completed · Not applicable

Conditions studied: ESRD

In brief

The goal of the COMprehensive EXercise (COMEX) pilot study is to test feasibility, tolerability and adherence of this novel video-based intra-dialytic chair exercise program for hemodialysis patients over 3 months.

Key facts

Study ID

NCT03055299

Run by

University of Pittsburgh

People needed

40

Starts

2017-02-20

Expected to finish

2018-04-30

Last updated by the study team

2018-07-03

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For patients:
• Age ≥18 years to 85 years
• Undergoing maintenance hemodialysis for >3 months at one of the participating dialysis sites
• Patients must be willing and able to sign the consent form.
• For providers:
• Eligible if they are a registered nurse, dialysis technician, dialysis social worker, dietitian, dialysis unit administrator or nephrologist involved in providing care for one of the patient participants in the study

You may not qualify if…

• For all patients:
• Uncontrolled BP (>180/100 mm Hg)
• Inadequately dialyzed (Kt/V<1.2)
• History of Intradialytic hypotension (SBP<90mm Hg) or hypertension (SBP>180mmHg) during/post dialysis within last 1 month
• Contraindication to exercise eg unstable angina, uncompensated congestive heart failure
• Refractory/untreated psychiatric disorders
• History of poor adherence to HD treatment.
• Scheduled for living donor kidney transplant, intention to change to peritoneal dialysis, home HD, or plans to relocate to another center within the next 6 months.
• Currently in acute or chronic care hospital
• Life expectancy < 6 months or intention to withdraw dialysis therapy within 6 months.
• Current pregnancy, or actively planning to become pregnant in the next 6 months
• Currently a prisoner
• Current use of investigational drugs or participation in another non-observational clinical trial that contradicts or interferes with the therapies or measured outcomes in this trial
• Unable or unwilling to follow the study protocol for any reason (including mental incompetence)
• Unable or unwilling to provide informed consent or sign IRB-approved consent form
• Has a tunneled dialysis catheter
• If diabetic, blood sugar control is not stable
• For patients undergoing biopsy and blood draw:
• Allergy to lidocaine
• Anemia, <10.0 Hgb
• Chronic use of oral corticosteroids or other medication that affect muscle function
• Any bleeding disorder that would contraindicate biopsy or blood draw such as a history of clinically significant bleeding diathesis (e.g. hemophilia A or B, Von Willebrand's Disease or congenital Factor VII deficiency)

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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