Clinical trial NCT03299101: Pilot Testing a Home-Based Rehabilitation Intervention Designed to Improve Outcomes of Frail Veterans Following Cardiothoracic Surgery
Official title: Pilot Testing a Home-based Rehabilitation Intervention Designed to Improve Outcomes of Frail Veterans Following Cardiothoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass Graft
Non-cardiac Thoracic Surgery
Frailty
Keywords: Frailty
Prehabilitation
Exercise therapy
Surgery
Nutrition support
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-10-02
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A novel a novel, multifaceted, home-based prehabilitation intervention designed to improve functional capacity and postoperative outcomes for frail Veterans anticipating cardiothoracic surgery. Prehabilitation will include: (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Frail Veterans are at increased risk for poor surgical outcomes, and as the Veteran population grows older and more frail, there is a critical need to identify effective strategies for reducing surgical risks for these patients. Prior research shows that inter-disciplinary rehabilitation strategies deployed after surgery enhance recovery and improve outcomes by building strength and improving nutrition. The investigators believe that similar improvements may be obtained by using similar interventions before surgery to "prehabilitate" patients' capacity to tolerate the stress of surgery. The proposed research will examine the feasibility of a new, home-based prehabilitation intervention aimed at improving surgical outcomes after cardiothoracic surgery through preoperative exercise training and nutritional supplementation. Findings from the study will inform the design of a larger randomized controlled trial of the prehabilitation intervention. If proven effective, prehabilitation could benefit as many as 42,000 frail Veterans who are scheduled for major elective surgery each year.

Detailed description: Background: Frail Veterans are at increased risk for poor surgical outcomes. Although surgical techniques have advanced to a level where surgery on very old adults is feasible, if a patient is also frail, the stress of surgery may overwhelm their adaptive capacities, placing them at increased risk of mortality, morbidity, and institutionalization even if surgery is technically successful. Frailty is a clinical syndrome that is commonly characterized by muscle atrophy, diminished strength and speed, decreased physical activity, and exhaustion. It is independent of any specific disease, but it increases with age and worsens disease prognoses by diminishing capacity to tolerate stressors. Thus, while surgery is often indicated for older patients, frail candidates are less likely than robust counterparts to tolerate the procedure and/or recover functional capacity. In fact, recent VA data demonstrate that frailty is a more powerful predictor of increased perioperative mortality, morbidity, length of stay, and cost than predictions based on age or comorbidity alone. As the Veteran and US populations grow older, frailty will increase, making it critically important to identify effective strategies for improving the surgical recovery and outcomes of frail patients.

"Prehabilitation" has the potential to improve surgical outcomes among the frail. Prior research demonstrates that inter-disciplinary rehabilitation strategies deployed after surgery enhance recovery and improve outcomes by building strength and improving nutrition. Based on this success, there is growing interest in "prehabilitation", which is a similar intervention deployed before surgery. By modifying physiological and environmental risks, prehabilitation aims to augment patients' capacity to compensate for the stress of surgery itself and the convalescent period thereafter. Frail patients may benefit disproportionately from prehabilitation because they have diminished capacity to endure the procedure and/or recovery. Preliminary evidence suggests that preoperative exercise interventions improve surgical outcomes. However, prehabilitation has not yet been studied in either Veteran or specifically frail populations, and no prior studies used home-based prehabilitation strategies to safely minimize travel-related barriers to participation.

Objectives: The investigators will examine the feasibility of a novel, multifaceted, home-based prehabilitation intervention designed to improve functional capacity and postoperative outcomes for frail Veterans anticipating cardiothoracic surgery. Specific aims are to:

1. Estimate rates of recruitment, retention, and adherence to the intervention; and evaluate participation barriers.
2. Measure changes over time in frailty, physical function, pulmonary function, nutrition, and health-related quality of life at baseline, the day of surgery, and 30 and 90 days after surgery.
3. Explore changes in postoperative mortality, major complications, length of hospital stay, and level of independent living using case-matched historical controls.

Methods: This single-arm pilot study will enroll a consecutive cohort of up to 50 Veterans identified as frail using a standardized frailty assessment and scheduled for major cardiothoracic surgery at the VA Pittsburgh Healthcare System. The 4 week long prehabilitation regimen will include: (a) aerobic conditioning, (b) strength and coordination training, (c) respiratory muscle training, and (d) nutritional coaching and supplementation. Pre- and post-prehabilitation assessments will include: (a) frailty; (b) physical function; (c) pulmonary function; (d) nutrition; and (e) health-related quality of life. Postoperative outcomes will include length of stay, mortality and complications. Compliance with the prehabilitation regimen will be assessed through patient logs and pedometers. Analyses will inform a larger randomized controlled trial testing the prehabilitation intervention. Findings will be relevant for the 42,000 frail Veterans scheduled for major elective surgery each year.

Eligibility criteria: Inclusion Criteria:

1. Veteran patient scheduled for Coronary artery bypass graft (CABG), valve surgery, or other non-cardiac thoracic surgery;
2. Demonstrate at least mild frailty (e.g., Risk Analysis Index \[RAI\]\>=16).
3. Physician/provider request for patients with RAI\<16.

Exclusion Criteria:

* Emergent, urgent, or otherwise time-sensitive surgery that precludes prehabilitation;
* Unstable or recent unstable cardiac syndrome as defined by (a) acute coronary syndrome within 6 weeks; (b) decompensated heart failure; (c) New York Heart Association Class IV Heart Failure; (d) unstable angina; (e) Canadian Cardiovascular Society Class IV symptoms; (f) critical left main coronary disease; (g) clinically significant arrhythmias,
* Severe valvular heart disease: (a) severe aortic or mitral stenosis (aortic or mitral valve area \<1.0 cm2 or mean gradient \>40 or \>10 mm Hg, respectively)
* Dynamic LV (Left Ventricle) outflow obstruction
* Physical, cognitive, social or logistical limitations preventing participation in the prehabilitation regimen, including:
* Patients who require surrogate consent for the planned surgery
* Patients with court orders of incompetence or clinical determinations of incapacity documented in the medical record
* Clinical exam by study physician consistent with incapacity
* Patients who at any time during prehabilitation or longitudinal follow up demonstrate insufficient cognitive capacity to safely and effectively carry out the prescribed activities.
* Unable to speak English.
* Surgery is cancelled by IMPACT clinic or surgeon due to unacceptable risk.

Primary outcomes:
measure: Recruitment Rate
timeFrame: Baseline
measure: Retention Rate
timeFrame: 90 days postoperatively
measure: Adherence Rate
timeFrame: Day of surgery
Secondary outcomes:
measure: Change in Grip Strength Over the Course of Treatment and Recovery.
timeFrame: Baseline, day of surgery, 90 days postoperatively
measure: Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MIP
timeFrame: Baseline, day of surgery, 90 days postoperatively
measure: Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MIP
timeFrame: Baseline, day of surgery, 90 days postoperatively
measure: Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MEP
timeFrame: Baseline, day of surgery, 90 days postoperatively
measure: Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MEP
timeFrame: Baseline, day of surgery, 90 days postoperatively
measure: Change in Pulmonary Function Over the Course of Treatment and Recovery: Max SMIP
timeFrame: Baseline, day of surgery, 90 days postoperatively
measure: Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean SMIP
timeFrame: Baseline, day of surgery, 90 days postoperatively
measure: Serum Prealbumin Over the Course of Treatment and Recovery
timeFrame: Baseline, day of surgery, 90 days postoperatively
measure: Change in Gait Speed Over the Course of Treatment and Recovery
timeFrame: Baseline, day of surgery, 90 days postoperatively
measure: Change in Short Physical Performance Battery (SPPB) Over the Course of Treatment and Recovery
timeFrame: Baseline, day of surgery, 90 days postoperatively
measure: Change in Risk Analysis Index of Frailty (RAI) Over the Course of Treatment and Recovery
timeFrame: Baseline, day of surgery, 90 days postoperatively
measure: Change in 7-point Subjective Global Assessment (SGA) of Nutrition Over the Course of Treatment and Recovery
timeFrame: Baseline, day of surgery, 90 days postoperatively
measure: Change in 6 Minute Walk Test Over the Course of Treatment and Recovery
timeFrame: Baseline, day of surgery, 90 days postoperatively
measure: Change in Health Related Quality of Life Over the Course of Treatment and Recovery
timeFrame: Baseline, day of surgery, 30-days postoperatively, 90-days postoperatively
Other outcomes:
measure: Change in Quality of Surgical Care Over the Course of Treatment and Recovery
timeFrame: Day of Surgery and 30-days postoperatively
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
name: Daniel E. Hall, MD MDiv MHSc
role: PRINCIPAL_INVESTIGATOR
References: