COMEX Study for Dialysis Patients (COMEX)

Comprehensive Exercise (COMEX) Program for Dialysis Patients Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: ESRD
• Intervention / Treatment: Other: COMEX intervention

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COMEX; Patients receive comprehensive exercise intervention	Other: COMEX intervention; Comprehensive Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Feasibility will be estimated by calculating the % of eligible participants who consent to participate in the study.	3 months
Number of participants with exercise-related adverse events	Tolerability will be measured by assessing exercise related side effects - this will be done by weekly patient interviews and review of medical records	3 months
Adherence rate	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	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2017
• Primary Completion (Actual): March 10, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: January 23, 2017
• First Submitted That Met QC Criteria: February 13, 2017
• First Posted (Actual): February 16, 2017

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PRO15070086

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No