COMEX Study for Dialysis Patients

University of Pittsburgh

Status

Completed

Conditions

ESRD

Treatments

Other: COMEX intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT03055299

PRO15070086

Details and patient eligibility

About

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.

Full description

The investigators incorporated patient-provider preferences of the key stakeholders, and used a multi-disciplinary team with experts in physical therapy, psychology and nephrology to develop a comprehensive exercise program for HD patients. Aim of this pilot study is to assess the feasibility, tolerability and adherence to COMEX over 3 months and inform design of future randomized controlled trial. A secondary goal is to explore molecular mechanisms in muscle and blood of exercise adaptation in HD patients

Enrollment

40 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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)