COMEX Study for Dialysis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-20

Study Completion Date

2018-04-30

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.

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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

Conditions

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ESRD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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COMEX

Patients receive comprehensive exercise intervention

Group Type EXPERIMENTAL

COMEX intervention

Intervention Type OTHER

Comprehensive Exercise

Interventions

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COMEX intervention

Comprehensive Exercise

Intervention Type OTHER

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No