COMEX Study for Dialysis Patients

Not Applicable

Completed

• Conditions: ESRD
• Interventions: Other: COMEX intervention

• Registration Number: NCT03055299
• Lead Sponsor: University of Pittsburgh

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

Study Timeline

• Study First Submitted: 2017-01-23
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-16
• Study Start: 2017-02-20
• Primary Completion: 2018-03-10
• Study Completion: 2018-04-30
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-02
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COMEX	COMEX intervention	Patients receive comprehensive exercise intervention

Primary Outcome Measures

Name	Time	Method
Recruitment rate	3 months	Feasibility will be estimated by calculating the % of eligible participants who consent to participate in the study.
Number of participants with exercise-related adverse events	3 months	Tolerability will be measured by assessing exercise related side effects - this will be done by weekly patient interviews and review of medical records
Adherence rate	3 months	Adherence will be calculated as % of participants who complete the 3 month COMEX intervention. Also, adherence to exercise will be calculated as % of exercise sessions completed

Secondary Outcome Measures

Name	Time	Method
Sleep	3 months	Self reported sleep using Pittsburgh Sleep Quality Index (PSQI) questionnaire will be measured at baseline and at 3 months
Fatigue	3 months	Self reported fatigue using Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Fatigue questionnaire will be measured at baseline and at 3 months
Depression	3 months	Self reported depression using Beck's Depression Inventory -II questionnaire will be measured at baseline and at 3 months
Global health	3 months	Self reported HRQOL using NIH Patient Reported Outcomes Measurement Information System (PROMIS) Adult Global Health questionnaire will be measured at baseline and at 3 months
Health related quality of life	3 months	Self reported HRQOL using Short-Form 36 questionnaire will be measured at baseline and at 3 months
Sleep/Wake Behavior by Actigraphy	3 months	Objective sleep and activity will be measured using actigraphy
Physical functioning	3 months	Will be measured by Short Physical Performance battery at baseline and 3 months

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States