In adults with stroke in the early subacute phase, aerobic treadmill-based physical fitness training was associated with increased risk for falls and was not superior to relaxation session with regard to maximal walking speed and activities of daily living, according to study results published in the BMJ.

As impairment in activities of daily living is high in adults with stroke, and no drug treatment was found to enhance rehabilitation, the goal of the current study was to assess the benefits of aerobic treadmill-based physical fitness training compared with relaxation as a control intervention.

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The multicenter, randomized controlled trial included adults from 7 inpatient rehabilitation centers in Germany diagnosed between 2013 and 2017 with subacute stroke, defined as days 5 to 45 after ischemic or hemorrhagic stroke.

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The study cohort comprised 200 adults (41% women; mean age, 69 years) with subacute stroke and moderate to severe impairment in activities of daily living. Of these, 105 patients were randomly assigned to receive aerobic, bodyweight-supported, treadmill-based physical training, and 95 participants completed a relaxation session; each regimen was completed over the course of 25 minutes, 5 times a week, for a total of 4 weeks.

The primary outcome measures were change in maximal walking speed, as assessed in a 10-m walk test and change in Barthel Index scores (range, 0-100 points, with higher scores indicating less disability) at 3 months after stroke compared with baseline. Primary safety outcomes were serious adverse events of recurrent cardiovascular events within 3 months after stroke.

The 4-week intervention of additional aerobic physical fitness training was not found to be superior to relaxation sessions in improving activities of daily living and maximal walking speed (adjusted mean change in maximal walking speed was 0.1 m/s; P =.23) at 3 months after stroke. The adjusted mean change in Barthel index score at 3 months after stroke was 30 points in both groups (P =.99).

Serious adverse events were more common in patients with aerobic physical fitness training compared with those in the relaxation group (22 vs 9 patients; incidence rate ratio, 1.81; 95% CI, 0.97-3.36). Although recurrent stroke and acute hospital admissions were more common among patients in the aerobic physical fitness training group, the differences were not statistically significant.

Self-reported falls during the intervention period were more common in patients in the aerobic physical fitness training group (treatment effect, 2.34; 95% CI, 1.26-4.34), whereas the risk for self-reported dizziness was higher for patients in the relaxation group (treatment effect, 0.33; 95% CI, 0.12-0.90).

The researchers acknowledged several study limitations, including possible variation in early neurologic recovery, short intervention period, and baseline differences in the severity of the stroke. Further, the investigators note that focusing only on patients with moderate to severe stroke may limit findings to this population of patients.

“Our trial provides evidence that an aerobic physical fitness training intervention with bodyweight support cannot be generally endorsed in adults after subacute stroke and should be administered with caution when applied early after moderate or severe stroke,” concluded the researchers.


Naveh AH, Rackoll T, Grittner U, et al. Physical fitness training in patients with subacute stroke (PHYS-STROKE): multicentre, randomised controlled, endpoint blinded trial. BMJ. 2019;366:l5101.

This article originally appeared on Neurology Advisor