BRISBANE, AUSTRALIA — Assigning patients with a recent HF hospitalization to a 24-week onsite exercise program did not improve 12-month mortality or readmissions vs a control group, a randomized trial shows.[1]
However, all patients in the trial, including the control group, followed a structured home-exercise protocol, and that may have made it hard for the on-site exercise intervention to confer any advantage, the researchers speculate.
Of note, “Three quarters of both the control and intervention group reported exercising to guidelines, far higher than other studies have reported,” Dr Alison M Mudge (Royal Brisbane and Women’s Hospital, Herston, Australia) told theheart.org | Medscape Cardiology.
And regardless of randomization assignment, exercising to guidelines-recommended levels, a secondary endpoint, was followed by a significantly reduced rate of death or readmission at both 3 months (P=0.008) and 6 months (P=0.012) compared with lower levels of exercise.
“Remarkably Effective”
When the trial was designed, a no-exercise control group was thought to be unethical, Mudge said. “So all patients had careful assessment by a specialist heart failure exercise professional, had an individually prescribed program based on their exercise capacity and preferences, and had regular support from the multidisciplinary heart failure disease management team.”
“A really important message of our trial is that this strategy of home exercise, supported as an integral part of multidisciplinary disease management, was remarkably effective,” she said. “Unfortunately, this likely diluted any effect of the center-based exercise-training program intervention, and I think is the most important reason we did not see a significant intervention effect.”
Mudge is principal investigator of the trial, called Exercise Joins Education: Combined Therapy to Improve Outcomes in Newly-Discharged Heart Failure (EJECTION-HF), and lead author on its publication January 29 in JACC: Heart Failure.
In an accompanying editorial,[2] Dr Jerome L Fleg (National Heart, Lung, and Blood Institute, Bethesda, MD) agrees that good exercise adherence all around made it hard for the intervention to alter clinical outcomes, and he notes several other issues that may have had the same effect.
Almost all of the population, for example, reported exercising more than 150 minutes per week at baseline, suggesting that they were “a relatively highly motivated sample that would be less likely to benefit from an exercise intervention,” Fleg writes.
Also, the 43-day median interval between hospital discharge and the start of the exercise intervention may have “prevented the intervention from having an effect during the high-risk period within the first 30 days after hospital discharge.”
Only a fifth of rehospitalizations over the 12 months were due to HF, Fleg also notes. “It may be anticipated that hospitalizations due to other comorbidities common in the older HF community would be less responsive to an exercise intervention than those due to HF.”
“A Huge Commitment”
EJECTION-HF entered 278 patients recently discharged from a heart failure hospitalization during 2008 to 2013 from one of five hospitals in Queensland, Australia.
The “individualized home exercise program” prescribed to all patients by a disease management program exercise specialist included moderate-intensity aerobic exercise for 30 minutes, 5 days per week, plus resistance exercises, the report notes.
The 140 patients randomly assigned to the on-site intervention “were encouraged” also to attend supervised group exercise training sessions at a gymnasium twice per week for 12 weeks, then once weekly for 12 weeks.
Overall, 62.6% met the primary endpoint of death or readmission within 12 months; the rates were 60% in the intervention group and 65.2% in the control group (P=0.37), for an odds ratio (OR) of 0.80 (95% CI, 0.49–1.30).
Significantly fewer patients in the intervention group died within 12 months, 2.1% vs 7.2% (P=0.04), but with so few events the authors caution against making too much of the finding.
There were signs that the tested exercise intervention might be appropriate for only selected patients. For example, the randomization groups made up only about 11% of those originally screened, and the remainder either did not meet eligibility criteria or declined to participate.
“A 6-month research study with 12 to 24 weeks of regular visits is a huge commitment for a 75-year-old with limited transport and six other active medical complaints,” Mudge observed. Many patients had comorbidities, such as chronic obstructive pulmonary disease or musculoskeletal pain.
Indeed, only 43% of the patients randomly assigned to supervised on-site exercise attended at least half of their assigned sessions.
Adherence to the intervention “was certainly a challenge,” Mudge said, adding that her group is looking for possible predictors of good or poor attendance at the on-site sessions, and how adherence to on-site or home exercise may have influenced outcomes.
“This might help us to identify which patients might benefit more from a structured program, and which might be better supported through home programs, rather than assuming one approach might be superior for all patients.”
Neither Mudge nor the other authors had relevant disclosures. Fleg had no relevant disclosures.
Follow Steve Stiles on Twitter: @SteveStiles2. For more from theheart.org | Medscape Cardiology, follow us on Twitter and Facebook.
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