Clinical trial NCT03055299: COMEX Study for Dialysis Patients
Official title: Comprehensive Exercise (COMEX) Program for Dialysis Patients Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ESRD
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-02-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility criteria: 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)

Primary outcomes:
measure: Recruitment rate
timeFrame: 3 months
measure: Number of participants with exercise-related adverse events
timeFrame: 3 months
measure: Adherence rate
timeFrame: 3 months
Secondary outcomes:
measure: Fatigue
timeFrame: 3 months
measure: Sleep
timeFrame: 3 months
measure: Depression
timeFrame: 3 months
measure: Global health
timeFrame: 3 months
measure: Health related quality of life
timeFrame: 3 months
measure: Sleep/Wake Behavior by Actigraphy
timeFrame: 3 months
measure: Physical functioning
timeFrame: 3 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
References: