COMEX Study for Dialysis Patients

ESRD Clinical Trial

— COMEX  

Official title:

Comprehensive Exercise (COMEX) Program for Dialysis Patients Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055299
• Other study ID #: PRO15070086
• Status: Completed
• Phase: N/A
• Start date: February 20, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: July 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 30, 2018
• Est. primary completion date: March 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• ESRD

Intervention

Other:
• COMEX intervention
Comprehensive Exercise

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Feasibility will be estimated by calculating the % of eligible participants who consent to participate in the study.	3 months
Primary	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
Primary	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	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
Secondary	Sleep	Self reported sleep using Pittsburgh Sleep Quality Index (PSQI) questionnaire will be measured at baseline and at 3 months	3 months
Secondary	Depression	Self reported depression using Beck's Depression Inventory -II questionnaire will be measured at baseline and at 3 months	3 months
Secondary	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
Secondary	Health related quality of life	Self reported HRQOL using Short-Form 36 questionnaire will be measured at baseline and at 3 months	3 months
Secondary	Sleep/Wake Behavior by Actigraphy	Objective sleep and activity will be measured using actigraphy	3 months
Secondary	Physical functioning	Will be measured by Short Physical Performance battery at baseline and 3 months	3 months