N/A
N=135
Effects of Personalized Physical Rehabilitation in Kidney Transplant Recipients
Kidney Transplant
Bottom Line
View on ClinicalTrials.gov: NCT02409901 ↗Enrolled (actual)
135
Serious AEs
—
Results posted
Nov 2024
Primary outcome: Primary: Employment Status — 21; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise Rehabilitation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Illinois at Chicago
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Employment Status |
21; 2 | — |
| SECONDARY Subclinical Atherosclerosis - PWV |
7.16; 6.06 | — |
| SECONDARY Functional Capacity - 6MW |
418.41; 405.95 | — |
| SECONDARY Body Composition - DEXA |
2858.10; 2550.69 | — |
| SECONDARY Metabolic State and Kidney Function - eGFR |
57.46; 62.48 | — |
| SECONDARY Quality of Life and Perceived Health Status - PROMIS 10 Global Physical Health Score |
51.58; 46.60 | — |
| SECONDARY Subclinical Atherosclerosis - IMT |
0.58; 0.57 | — |
| SECONDARY Functional Capacity - Strength (Away) |
108.02; 100.01 | — |
| SECONDARY Regular Physical Activity Using Accelerometers |
16.46; 11.75 | — |
| SECONDARY Metabolic State and Kidney Function - Serum Creatinine (SCr) |
1.46; 1.37 | — |
| SECONDARY Quality of Life and Perceived Health Status - PROMIS 29 Physical Function Score |
48.89; 46.45 | — |
| SECONDARY Quality of Life and Perceived Health Status - PROMIS 10 Global Mental Health Score |
53.11; 49.53 | — |
| SECONDARY Functional Capacity - Strength (Towards) |
44.53; 41.61 | — |
| SECONDARY Pain Intensity |
1.98; 3.21 | — |
| SECONDARY Body Composition - Waist Circumference |
45.50; 45.33 | — |
| SECONDARY Body Composition - Body Mass Index (BMI) |
35.90; 35.12 | — |
| SECONDARY Systolic Blood Pressure |
132.92; 129.71 | — |
| SECONDARY Diastolic Blood Pressure |
80.83; 82.46 | — |
Summary
This randomized controlled trial (RCT) will examine the effect of a novel 12 month personalized exercise rehabilitation program compared to standard care following kidney transplantation. Return to work or find work rates, markers of subclinical atherosclerosis, functional capacity, body composition, quality of life, kidney function, and adherence to exercise will be measured. The investigators' primary hypothesis is that a 12 month exercise rehabilitation program will increase the return to work or find work rate in kidney transplant recipients. The investigators additionally hypothesize that a 12 month exercise rehabilitation program will prevent a decline in subclinical atherosclerosis, increase functional capacity, and increase lean muscle mass.
Eligibility Criteria
Inclusion Criteria
- at least 2 moths post-transplant
- must have adequate cognitive ability to complete questionnaires, give consent for the study and follow the physical instructions
Exclusion Criteria
- any other organ besides kidney or kidney/pancreas mix
- any surgery or procedure to assist in weight loss (ie bariatric surgery)
- non-ambulatory or significant orthopedic problems
- cardiac/pulmonary disease that contraindicates the physical training
- any contraindication to exercise testing per the American Heart Association
- if the patient is unable to comply with the training program
Data sourced from ClinicalTrials.gov (NCT02409901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.