N/A
N=60
Increasing Activity Post-Kidney Transplant With SystemCHANGE
Kidney Transplant; Complications · Physical Activity · Cardiorenal; Change · Cardiovascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03191630 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Steps Taken Per Day by Using an Activity Tracker — 4710; 5708; 4157; 4981 average of steps per day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fitbit (Control) (Behavioral); SystemCHANGE and Fitbit (Intervention) (Behavioral)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Steps Taken Per Day by Using an Activity Tracker |
4710; 5708; 4157; 4981; 3608; 4766 | — |
| SECONDARY Six Minute Walk Test |
1142; 1158; 1204; 1142; 1146; 1120 | — |
| SECONDARY Resting Blood Pressure |
146.7; 140.7; 80.52; 79.52; 142.2; 143.3 | — |
| SECONDARY Quality of Life: Physical (Functional) and Mental (Well-being) Health" |
45.32; 40.37; 44.69; 40.91; 45.71; 40.02 | — |
| SECONDARY Weight (Pounds) |
193.1; 188.5; 192.6; 186.6; 189.0; 189.3 | — |
| SECONDARY Radial Pulse (Beats Per Minute) |
70.20; 69.08; 70.20; 67.56; 67.21; 66.82 | — |
| SECONDARY Body Mass Index (BMI)kg/m2 |
30.3; 31.3; 29.5; 30.7; 28.4; 29.5 | — |
| SECONDARY Health Outcome: Waist Circumference (cm) |
39.76; 39.22; 39.08; 38.68; 38.42; 38.70 | — |
Summary
Inactivity is a common problem among older kidney transplant recipients (KTRs) and is associated with their high incidence of obesity and cardiovascular problems which are the leading cause of death for KTRs. However, the combination of SystemCHANGE activity trackers holds promise for increasing physical activity of KTR patients post-surgery.
This pilot study will incorporate Fitbit health trackers with an intervention of questions about influences to physical activity in a population of kidney transplant recipients who are at particularly high risk of cardiovascular disease and death.
Eligibility Criteria
Inclusion Criteria
- Kidney transplant recipient at The Ohio State University Wexner Medical Center, Kidney Transplant Program
- Age 60 or older
- Received clearance from healthcare provider to participate
- Ability to speak, read, and hear English
- Possession or ready-access to a smart phone capable of accessing mobile activity tracker data
- Lacks cognitive impairment (verified by mini cognition test)
- Able to walk without an assist device (cane or walker)
- Not currently hospitalized
- Greater than 3 months post- transplant
Exclusion Criteria
- Currently on dialysis
- Currently participating in a weight loss program
- Currently participating in a structured exercise program
- Currently wearing/using an activity tracker
- Planning to relocate out of the Columbus area in the next 6 months or less
Data sourced from ClinicalTrials.gov (NCT03191630). 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.