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

NCT03299101 | Completed Results

• 2 other identifiers: E2562-PI21RX002562
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Frailty; Prehabilitation; Exercise therapy; Surgery; Nutrition support

Outcome Measures

Primary Outcomes (3)

• Recruitment Rate

  Recruitment will be expressed as the percentage of eligible patients approached who agree to participate in this pilot study.

  Baseline

• 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

• 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 Outcomes (14)

• Change in Grip Strength Over the Course of Treatment and Recovery.

  Baseline, day of surgery, 90 days postoperatively

• Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MIP

  Baseline, day of surgery, 90 days postoperatively

• Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MIP

  Baseline, day of surgery, 90 days postoperatively

• Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MEP

  Baseline, day of surgery, 90 days postoperatively

• Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MEP

  Baseline, day of surgery, 90 days postoperatively

Other Outcomes (1)

• Change in Quality of Surgical Care Over the Course of Treatment and Recovery

  Day of Surgery and 30-days postoperatively

Study Arms (1)

Prehabilitation

EXPERIMENTAL

Prospective sample of patients anticipating cardiothoracic surgery.

Other: Prehabilitation

Interventions

Prehabilitation OTHER

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.

Prehabilitation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

MeSH Terms

Conditions

Frailty

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Daniel E Hall
• Organization: Pittsburgh VA Healthcare System, CHERP

daniel.hall2@va.gov

4123602016

Study Officials

• Daniel E. Hall, MD MDiv MHSc

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: October 2, 2017
• Study Start: November 22, 2017
• Primary Completion: April 30, 2020
• Study Completion: September 30, 2020
• Last Updated: January 13, 2021
• Results First Posted: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)