ESRD
Conditions
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.
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
Interventions
OTHERCOMEX intervention
Comprehensive Exercise
Sponsors
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 3 months | Feasibility will be estimated by calculating the % of eligible participants who consent to participate in the study. |
| Number of participants with exercise-related adverse events | 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 |
| Adherence rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Global health | 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 |
| Health related quality of life | 3 months | Self reported HRQOL using Short-Form 36 questionnaire will be measured at baseline and at 3 months |
| Fatigue | 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 |
| Physical functioning | 3 months | Will be measured by Short Physical Performance battery at baseline and 3 months |
| Sleep/Wake Behavior by Actigraphy | 3 months | Objective sleep and activity will be measured using actigraphy |
| Sleep | 3 months | Self reported sleep using Pittsburgh Sleep Quality Index (PSQI) questionnaire will be measured at baseline and at 3 months |
| Depression | 3 months | Self reported depression using Beck's Depression Inventory -II questionnaire will be measured at baseline and at 3 months |
Countries
United States
Outcome results
None listed