A controlled clinical trial of leg thermal therapy in conjunction with standard cardiac rehabilitation in patients with decompensated heart failure.
Tomoyuki Ogino, Hideyuki Kondo, Makoto Okada and 1 others
PMID 40511315WHAT IT FOUND
Adding leg heating to cardiac rehabilitation did not show improvement in peak exercise capacity in 10 patients given leg heating and 6 given rehabilitation alone after decompensated heart failure.
Leg heating was safe, but changes in the leg-heating group alone cannot show benefit.
Key findings
01The primary outcome, peak oxygen uptake, did not differ significantly between groups and did not change significantly before and after intervention in either group.
02Within the leg-heating group, anaerobic threshold oxygen uptake increased and noradrenaline decreased, but there were no significant between-group differences in secondary outcomes.
03No intervention-related complications occurred during the study period.
STILL TO COME
How it was doneWhat they foundWhat it means for PTs
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What it does not show
Only 10 patients in the leg-heating group and 6 in the control group were analysed after 17 were enrolled and one leg-heating patient was excluded during the intervention. The trial was planned for approximately 100 participants but ended early because of the coronavirus disease 2019 outbreak. Allocation was pseudorandomized by even and odd medical record numbers, participants and their physical therapists knew the treatment, and assessors were not blinded. All patients received standard cardiac rehabilitation and guideline-based heart failure treatment, so within-group changes in anaerobic threshold oxygen uptake or noradrenaline cannot be separated from those treatments. The study was single-center and enrolled older patients with severe heart failure, so results cannot be generalized. Intervention duration varied, and patients discharged before one month were evaluated ahead of schedule.
Declared interests
There were no sources of funding, and the authors declared no conflicts of interest.
The easy way to misread this
Do not conclude that leg thermal therapy improves exercise capacity. The primary outcome, peak oxygen uptake, showed no significant difference between groups or within groups, and the positive anaerobic threshold and noradrenaline findings were within-group secondary results in a very small unblinded trial where all patients also received cardiac rehabilitation.