Pilot Testing a Home-Based Rehabilitation Intervention Designed to Improve Outcomes of Frail Veterans Following Cardiothoracic Surgery

Frailty Clinical Trial

Official title:

Pilot Testing a Home-based Rehabilitation Intervention Designed to Improve Outcomes of Frail Veterans Following Cardiothoracic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03299101
• Other study ID #: E2562-P
• Secondary ID: I21RX002562
• Status: Completed
• Phase: N/A
• Start date: November 22, 2017
• Est. completion date: September 30, 2020

Study information

• Verified date: December 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Bypass Graft
• Frailty
• Non-cardiac Thoracic Surgery

Intervention

Other:
• Prehabilitation
Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.

Locations

Country	Name	City	State
United States	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Quality of Surgical Care Over the Course of Treatment and Recovery	Agency for Healthcare Research and Quality (AHRQ) Surgical Care Survey (SCS) total communication section. Values are scored on a 3 point scale where 1 is good and 3 bad	Day of Surgery and 30-days postoperatively
Primary	Recruitment Rate	Recruitment will be expressed as the percentage of eligible patients approached who agree to participate in this pilot study.	Baseline
Primary	Retention Rate	Retention rate will be expressed as the percentage of enrolled patients who were retained in the study and completed study procedures. It will be calculated for incremental steps along the study timeline and at the completion of study procedures 90 days postoperatively.	90 days postoperatively
Primary	Adherence Rate	Compliance rates will be expressed as the percentage of assigned activities actually completed by patients as recorded in home exercise and nutrition logs.	Day of surgery
Secondary	Change in Grip Strength Over the Course of Treatment and Recovery.	Grip strength will be measured in kilograms of pressure using a Smedley grip dynamometer	Baseline, day of surgery, 90 days postoperatively
Secondary	Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MIP	Pulmonary function will be measured in terms of maximum MIP (maximal inspiratory pressure).	Baseline, day of surgery, 90 days postoperatively
Secondary	Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MIP	Pulmonary function will be measured in terms of mean maximal inspiratory pressure (MIP).	Baseline, day of surgery, 90 days postoperatively
Secondary	Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MEP	Pulmonary function will be measured in terms of maximum MEP (maximal expiratory pressures)	Baseline, day of surgery, 90 days postoperatively
Secondary	Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MEP	Pulmonary function will be measured in terms of mean maximal expiratory pressures (MEP).	Baseline, day of surgery, 90 days postoperatively
Secondary	Change in Pulmonary Function Over the Course of Treatment and Recovery: Max SMIP	Pulmonary function will be measured in terms of maximum sustained MIP (SMIP).	Baseline, day of surgery, 90 days postoperatively
Secondary	Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean SMIP	Pulmonary function will be measured in terms of mean sustained MIP (SMIP).	Baseline, day of surgery, 90 days postoperatively
Secondary	Serum Prealbumin Over the Course of Treatment and Recovery	Higher levels indicate greater levels of protein. Lower levels indicate the potential of inflammation. normal range is 18-41, Below 18 is lower than normal, above 41 is higher than normal	Baseline, day of surgery, 90 days postoperatively
Secondary	Change in Gait Speed Over the Course of Treatment and Recovery	Gait speed will be measured by using a stopwatch to time how long the patient takes to walk 4 meters	Baseline, day of surgery, 90 days postoperatively
Secondary	Change in Short Physical Performance Battery (SPPB) Over the Course of Treatment and Recovery	This standardized outcome measure asks patients to complete several activities that are scored independently and then aggregated into an overall score ranging from 0-12. Higher scores indicate better physical performance.	Baseline, day of surgery, 90 days postoperatively
Secondary	Change in Risk Analysis Index of Frailty (RAI) Over the Course of Treatment and Recovery	This recently published frailty index is assessed by a clinician administered questionnaire. The score and reflects frailty-associated mortality risk ranging from 0-81. Higher scores indicate higher risk for post operative complications and other frailty-related outcomes.	Baseline, day of surgery, 90 days postoperatively
Secondary	Change in 7-point Subjective Global Assessment (SGA) of Nutrition Over the Course of Treatment and Recovery	This standardized survey instrument is completed by a trained clinician after assessing a nutrition-specific patient history. The minimum score is 1 and the maximum score is 7. High scores indicate better nourishment.	Baseline, day of surgery, 90 days postoperatively
Secondary	Change in 6 Minute Walk Test Over the Course of Treatment and Recovery	This standardized approach measures the distance in meters walked during 6 minutes.	Baseline, day of surgery, 90 days postoperatively
Secondary	Change in Health Related Quality of Life Over the Course of Treatment and Recovery	Assessment of Quality of Life (AQoL-6D) survey. Scores range from 0 to 1. The higher the score, the better the quality of life.	Baseline, day of surgery, 30-days postoperatively, 90-days postoperatively