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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COMEX | Experimental | Patients receive comprehensive exercise intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COMEX intervention | Other | Comprehensive Exercise |
|
| 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 |
| 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 |
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Inclusion Criteria:
For patients:
For providers:
Exclusion Criteria:
For all patients:
For patients undergoing biopsy and blood draw:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37928754 | Derived | Jhamb M, Devaraj SM, Alemairi M, Lavenburg LM, Shiva S, Yabes JG, Forman DE, Hergenroeder AL. A Comprehensive Exercise (COMEX) Intervention to Optimize Exercise Participation for Improving Patient-Centered Outcomes and Physical Functioning in Patients Receiving Hemodialysis: Development and Pilot Testing. Kidney Med. 2023 Sep 12;5(11):100720. doi: 10.1016/j.xkme.2023.100720. eCollection 2023 Nov. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| 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 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |