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COMEX Study for Dialysis Patients (COMEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055299
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Manisha Jhamb, 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.

Condition or disease Intervention/treatment Phase
ESRD Other: COMEX intervention Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comprehensive Exercise (COMEX) Program for Dialysis Patients Pilot Study
Actual Study Start Date : February 20, 2017
Actual Primary Completion Date : March 10, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: COMEX
Patients receive comprehensive exercise intervention
Other: COMEX intervention
Comprehensive Exercise




Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: 3 months ]
    Feasibility will be estimated by calculating the % of eligible participants who consent to participate in the study.

  2. Number of participants with exercise-related adverse events [ Time Frame: 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

  3. Adherence rate [ Time Frame: 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 :
  1. Fatigue [ Time Frame: 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

  2. Sleep [ Time Frame: 3 months ]
    Self reported sleep using Pittsburgh Sleep Quality Index (PSQI) questionnaire will be measured at baseline and at 3 months

  3. Depression [ Time Frame: 3 months ]
    Self reported depression using Beck's Depression Inventory -II questionnaire will be measured at baseline and at 3 months

  4. Global health [ Time Frame: 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

  5. Health related quality of life [ Time Frame: 3 months ]
    Self reported HRQOL using Short-Form 36 questionnaire will be measured at baseline and at 3 months

  6. Sleep/Wake Behavior by Actigraphy [ Time Frame: 3 months ]
    Objective sleep and activity will be measured using actigraphy

  7. Physical functioning [ Time Frame: 3 months ]
    Will be measured by Short Physical Performance battery at baseline and 3 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055299


Locations
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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
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Responsible Party: Manisha Jhamb, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03055299    
Other Study ID Numbers: PRO15070086
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No