COMEX Study for Dialysis Patients

Study Overview
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Brief Summary
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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
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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

Official Title
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Comprehensive Exercise (COMEX) Program for Dialysis Patients Pilot Study

Conditions
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ESRD

Intervention / Treatment
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* Other: COMEX intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COMEX<br>Patients receive comprehensive exercise intervention | Other: COMEX intervention<br>* Comprehensive Exercise<br>|

What is the study measuring?
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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 |