A Pilot Randomized Controlled Trial Using SystemCHANGE™ Approach to Increase Physical Activity in Older Kidney Transplant Recipients.
Tara O'Brien, Cynthia L Russell, Alai Tan and 5 others
PMID 32912051WHAT IT FOUND
The 6-month step difference was not significant, but older kidney transplant recipients who received a Fitbit plus monthly routine-based goal-setting sessions had 608 more daily steps than control at 3 months.
Resting heart rate fell 6.3 beats per minute more than control.
Key findings
01Baseline daily steps were similar between groups. The intervention group's average daily steps were 608 higher than control at 3 months (mean difference, P=0.03), but at 6 months the mean difference was 479 and not significant (P=0.09).
02Resting heart rate decreased in the intervention group from baseline to 6 months, and the between-group decrease was 6.3 beats per minute compared with control (P=.04); systolic blood pressure did not differ between groups after 6 months.
03The pilot met its recruitment target of 60 participants, had 17% six-month attrition, and high meeting attendance (93% intervention, 96% control).
STILL TO COME
How it was doneWhat they foundWhat it means for PTs
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What it does not show
The study was a pilot with 60 randomized participants and final sample of 27 intervention and 26 control, so it was not powered to prove effectiveness. Post hoc power was 43% for a medium between-group effect, so real effects could have been missed. Participants had to walk without assistive devices and attend monthly face-to-face sessions, and many potential participants lived more than 2 hours away, so the results may not apply to older transplant recipients with mobility aids or limited access. The intervention was SystemCHANGE plus a Fitbit plus monthly group sessions, and the control group also had a Fitbit plus monthly education sessions, so the trial cannot identify which component mattered. The authors did not collect hypertension diagnosis or antihypertensive medication use, so blood pressure findings may be confounded. The sample came from a single Midwest transplant center.
Declared interests
The supplied metadata indicates NIH extramural support; the article text does not report author conflicts of interest.
The easy way to misread this
Do not read the 3-month step increase or the 6.3 beats per minute heart-rate difference as proof that SystemCHANGE works by itself. The study was a small pilot, the 6-month step difference was not significant, and the intervention was SystemCHANGE plus a Fitbit plus monthly group sessions, while the control group also had a Fitbit plus monthly education sessions, so the active components cannot be separated.