Decade in Exercise 'Club' Ups Functional Capacity, Hints at Clinical Gains

September 21, 2012

September 20, 2012 (Ancona, Italy) — Heart-failure patients who followed a moderate-intensity exercise training program for 10 years benefited with gains in functional capacity and quality of life in a small randomized trial [1].

Even with the unusually long follow-up, the trial had a low dropout rate and patients adhered to the exercise protocol 88% of the time. Researchers attributed that to training that was closely supervised during the first year and subsequently conducted mostly in a "coronary club," a group setting with other cardiac patients.

"Because of its social networking, the coronary club may represent an efficient model to follow for a large segment of congestive heart failure patients to participate in a long-term cardiac rehabilitation program," write the authors, led by Dr Romualdo Belardinelli (Lancisi Heart Institute, Ancona, Italy), in a newly published report in the Journal of the American College of Cardiology.

Functional capacity as measured by peak VO2 improved 14.7% with exercise training and declined somewhat in a usual-care control group; heart rate showed similar improvement.

Enticingly, patients randomized to exercise training compared with usual care also showed a 36% decline in hospital admissions and 32% fall in cardiac mortality (p<0.001 for both). But the authors themselves acknowledge that the 123-patient trial was underpowered for such events.

Still, according to Belardinelli et al, "the results of this study are unique," because of its unparalleled duration, high levels of training supervision and adherence, and use of the coronary-club format to, in part, promote compliance.

Compared and Contrasted to HF-ACTION

The study invites comparison with the international, randomized HF-ACTION trial, which saw only about a 4% improvement in functional capacity in heart-failure patients following an intensive exercise program and evaluated at a mean of 2.5 years and no exercise effect on its primary end point of all-cause death or hospitalization.

The authors point out noteworthy differences between their trial and HF-ACTION, other than duration; in the latter trial, exercise mostly wasn't supervised and was performed at home, and its patients had lower adherence to the prescribed exercise plan.

In an accompanying editorial [2], HF-ACTION investigator Dr David J Whellan (Jefferson Medical College, Philadelphia, PA) related some other differences between the trials. The rate of beta-blocker use in the current study was about half that of the larger trial, and many times more patients in the latter had implantable defibrillators.

"Given the proven benefit of these treatments in patients with HF, it is unlikely that the present study would have achieved such a large risk reduction as detected in this cohort," he writes.

On the other hand, according to Whellan, the "remarkable adherence" to exercise in the current study, 88% as compare about 60% in HF-ACTION, "provides some valuable lessons."

In HF-ACTION, with >2500 patients, the intensive exercise program was initially supervised but thereafter conducted at home without supervision. In a secondary analysis, the patients who most adhered to exercise training had the best clinical outcomes.

Crediting the current study's use of supervised training and the coronary-club formats to promote adherence, Whellan writes "this strategy can be easily incorporated into the modern cardiac-rehabilitation model used in the treatment of patients, but providing this level of supervision over 10 years, or even 12 months as done in [HF-ACTION], would be difficult to implement, in terms of both feasibility and cost."

According to Dr Carl Lavie (Ochsner Health System, New Orleans, LA), not an investigator with either trial, the "much more impressive" gains in peak VO2 in the current study compared with HF-ACTION led to "more meaningful reductions in major cardiovascular end points."

But, he explained to heartwire , the current study involved relatively few patients and unusually long-term follow-up, "and translating this to the routine management of the very large number of patients with advanced heart failure will be a challenge. Currently, Medicare and most insurance companies do not even pay for short-term exercise training programs in heart failure, much less long-term programs. Certainly, efforts are needed to get secondary payers to cover this potentially very valuable therapy and to find ways to get patients with advanced heart failure to comply with efforts to improve physical activity and levels of exercise."

Exercise Training or Disease Management?

The current study randomized 123 patients with NYHA functional class 2–3 of various etiologies and LVEF <40% who had been clinically stable for at least three months to follow the exercise program or usual care. Of note, the latter included instructions to refrain from any supervised exercise training as well as any high-intensity exercise.

In the exercise group, 63 completed the 10-year protocol, which was followed from 1994 to 2005; 60 in the usual-care group completed the study.

Peak VO2 rose by 14.7% in the exercise group and fell 2.5% in controls, with an absolute difference at 10 years of 3.6 mL/kg/min (p=0.01).

Also at 10 years, mean scores for multiple components of the Minnesota Living with Heart Failure Questionnaire were significant lower (better) in the exercise group: 43 vs 58 for the usual-care group (p<0.05).

The hazard ratio (HR) for the exercise group vs control group for hospital readmission was 0.64 (95% CI 0.34–0.81) and for cardiac mortality was 0.68 (95% CI 0.30–0.82; p<0.001 for both).

According to Whellan, "When the additional interactions with the supervising cardiologist and exercise physiologists and the educational focus of the coronary club are taken into account, one has to question if this was a study of exercise training or a study evaluating a disease-management strategy or model of healthcare delivery outside the hospital that includes exercise training as a core component."

He writes further, "Instead of shying away from the reality that training interventions are more than just exercise, investigators need to better define the totality of the intervention being provided," he writes. Better systems for identifying the components of such training programs that may have separate effects would "allow providers a better opportunity to replicate the interventions in their communities."

Belardinelli et al, Whellan, and Lavie had no relevant disclosures.

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