Grand Rounds October 3, 2025: Multi-Domain Rehabilitation for Older Patients With Myocardial Infarction: The PIpELINe Trial (Elisabetta Tonet, MD)

Speaker

Elisabetta Tonet, MD
Cardiology Consultant
Cardiology Unit
Azienda Ospedaliero–Universitaria di Ferrara, Italy

Keywords

Cardiovascular; Myocardial Infarction; Rehabilitation

Key Points

  • The standard of care in myocardial infarction (MI) management has evolved dramatically in the 20th century, shifting from absolute bed rest to early ambulation to the modern cardiac rehabilitation concept focused on physical activity. This typically includes inpatient mobilization, a 6 – 12 week outpatient program, and a maintenance phase.
  • Traditional cardiac rehabilitation programs have several limitations, including standardized activities, early withdrawal, high costs, and low enrollment of older adults. The latter factor is increasingly significant, as the contemporary MI patient has also changed; 2/3 of MI patients are over 65 years old.
  • Despite advancements in acute care, older patients presenting with MI are the highest risk population with the worst prognosis. Older adults also represent the least physically active group, often experiencing functional decline, frailty and disability after MI.
  • The research team sought to assess a physical activity model with both remote and supervised, in-person, monthly sessions. In the HULK pilot study, this intervention was seen to improve short physical performance battery values 6 months after acute coronary syndrome.
  • The Physical Activity Intervention in Elderly Patients with Myocardial Infarction (PIpELINe) trial evaluated whether an early, tailored, multi-domain rehabilitation intervention improved outcomes in older patients (65+ years old) admitted to the hospital for MI and with impaired physical performance.
  • PIpELINe was an investigator-initiated, multicenter, prospective, superiority randomized trial conducted across 7 centers in Italy. The intervention included metabolic risk factors management; diet counseling; and exercise training. The primary outcome was cardiovascular (CV) death or CV-related, unplanned hospitalization.
  • The research team found that the multi-domain cardiac rehabilitation program reduced CV death or CV-related, unplanned hospitalization in their target population by 8% compared to usual care.

Discussion Themes

One difficulty cited by similar projects is older adults’ reluctance to participate in clinical trials. In this case, the research team found that a monthly, sustained program that provided guidance following an MI was attractive to this population. The main barrier to enrollment was the pandemic.

The impact of the intervention on heart failure and unplanned hospitalization may be more pertinent to this population than CV death, as they pertain to functional decline and quality of life.

The monthly pace renders this intervention low-cost with high availability.

The multidimensionality of the trial makes it difficult to identify which factors drove the effectiveness of the intervention and to what extent. Dr. Tonet suspects that the physical activity component was the most impactful.

Grand Rounds September 6, 2024: Conventional, Complementary, and Integrative Pain Therapies in a Military Population with Chronic Musculoskeletal Pain: Results of a Pragmatic Clinical Trial Using SMART Design (Ardith Z. Doorenbos, PhD, RN; Diane M. Flynn, MD, MPH)

Speakers

Ardith Z. Doorenbos, PhD, RN
Professor
Department of Biobehavioral Nursing Science
College of Nursing
University of Illinois, Chicago

Diane M. Flynn, MD, MPH
Primary Care Pain Management Advisor
Interdisciplinary Pain Management Center
Madigan Army Medical Center
Tacoma, WA

Keywords

Chronic Pain; Military; Rehabilitative Care; Pain Therapies; SMART Design

Key Points

  • Physical and occupational therapies are standard rehabilitative care (SRC) for chronic pain, and a growing body of evidence supports complementary and integrative health (CIH) therapies (such as acupuncture, chiropractic, yoga and massage).
  • Few studies have explored the optimal duration, sequence and combination of SRC and CIH to manage chronic pain.
  • The study team investigated the effectiveness of starting treatment for pain with SRC versus CIH therapies. Their primary outcome was the Pain Impact Scores of active-duty service members with chronic pain.
  • Their study design, a Sequential Multiple Assignment Randomized Trial (SMART) Design, randomized participants to CIH or SRC for three weeks each. At that point, participants who were improving continued on in their assigned treatment arm, while those who were not improving were randomized to either the other treatment arm or a combination arm.
  • Compared to baseline pain levels, both groups improved significantly up to six months out. After three weeks, the group that received SRT showed less improvement the group that received CIH therapies. However, by the end of the six-week mark, as well as at three- and six-month follow-ups, there wasn’t a significant difference in average improvement.
  • The study team’s ability to make assessments with regard to the duration of treatment is limited; participants were given the option to continue therapy for up to six weeks, so some were engaged in active therapy during the follow-up period.
  • These findings lend support to expanding access to CIH approaches. Clinicians can feel confident recommending patients start with CIH therapies if that is the patients’ preference.

Discussion Themes

Patients in the CIH arm and SRT arm received therapy for a total of 6.5 and 3 hours per week, respectively. At first blush, this indicates that a treatment hours effect could have contributed to the benefits seen in the first three weeks of the CIH arm; in practice, due to lower-than-intended participation, the actual treatment hours were only slightly higher in the CIH arm than the SRT arm.

Whether it’s caused by pain, combat experience, or adverse childhood experiences, many members of the study population experience a great deal of allostatic stress and kinesiophobia: “When I move, I hurt.” One of the study team’s theories as to why participants initially responded more positively to the CIH arm is that there was less movement involved.

Future directions may include examining the biological or neurological mechanisms underlying the interventions’ impact.

Dr. Flynn shared a resource that she noted would be helpful in defining SMART Designs and outlining some of the advantages and disadvantages:  https://jamanetwork.com/journals/jama/article-abstract/2800681