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

December 21, 2020 updated by: VA Office of Research and Development

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15240
        • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prehabilitation
Prospective sample of patients anticipating cardiothoracic surgery.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment Rate
Time Frame: Baseline
Recruitment will be expressed as the percentage of eligible patients approached who agree to participate in this pilot study.
Baseline
Retention Rate
Time Frame: 90 days postoperatively
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
Time Frame: Day of surgery
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Grip Strength Over the Course of Treatment and Recovery.
Time Frame: Baseline, day of surgery, 90 days postoperatively
Grip strength will be measured in kilograms of pressure using a Smedley grip dynamometer
Baseline, day of surgery, 90 days postoperatively
Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MIP
Time Frame: Baseline, day of surgery, 90 days postoperatively
Pulmonary function will be measured in terms of maximum MIP (maximal inspiratory pressure).
Baseline, day of surgery, 90 days postoperatively
Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MIP
Time Frame: Baseline, day of surgery, 90 days postoperatively
Pulmonary function will be measured in terms of mean maximal inspiratory pressure (MIP).
Baseline, day of surgery, 90 days postoperatively
Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MEP
Time Frame: Baseline, day of surgery, 90 days postoperatively
Pulmonary function will be measured in terms of maximum MEP (maximal expiratory pressures)
Baseline, day of surgery, 90 days postoperatively
Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MEP
Time Frame: Baseline, day of surgery, 90 days postoperatively
Pulmonary function will be measured in terms of mean maximal expiratory pressures (MEP).
Baseline, day of surgery, 90 days postoperatively
Change in Pulmonary Function Over the Course of Treatment and Recovery: Max SMIP
Time Frame: Baseline, day of surgery, 90 days postoperatively
Pulmonary function will be measured in terms of maximum sustained MIP (SMIP).
Baseline, day of surgery, 90 days postoperatively
Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean SMIP
Time Frame: Baseline, day of surgery, 90 days postoperatively
Pulmonary function will be measured in terms of mean sustained MIP (SMIP).
Baseline, day of surgery, 90 days postoperatively
Serum Prealbumin Over the Course of Treatment and Recovery
Time Frame: Baseline, day of surgery, 90 days postoperatively
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
Change in Gait Speed Over the Course of Treatment and Recovery
Time Frame: Baseline, day of surgery, 90 days postoperatively
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
Change in Short Physical Performance Battery (SPPB) Over the Course of Treatment and Recovery
Time Frame: Baseline, day of surgery, 90 days postoperatively
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
Change in Risk Analysis Index of Frailty (RAI) Over the Course of Treatment and Recovery
Time Frame: Baseline, day of surgery, 90 days postoperatively
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
Change in 7-point Subjective Global Assessment (SGA) of Nutrition Over the Course of Treatment and Recovery
Time Frame: Baseline, day of surgery, 90 days postoperatively
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
Change in 6 Minute Walk Test Over the Course of Treatment and Recovery
Time Frame: Baseline, day of surgery, 90 days postoperatively
This standardized approach measures the distance in meters walked during 6 minutes.
Baseline, day of surgery, 90 days postoperatively
Change in Health Related Quality of Life Over the Course of Treatment and Recovery
Time Frame: Baseline, day of surgery, 30-days postoperatively, 90-days postoperatively
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Quality of Surgical Care Over the Course of Treatment and Recovery
Time Frame: Day of Surgery and 30-days postoperatively
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel E. Hall, MD MDiv MHSc, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 22, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E2562-P
  • I21RX002562 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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