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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03299101
Recruitment Status : Active, not recruiting
First Posted : October 2, 2017
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Bypass Graft Non-cardiac Thoracic Surgery Frailty Other: Prehabilitation Not Applicable

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 30 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Pilot Testing a Home-based Rehabilitation Intervention Designed to Improve Outcomes of Frail Veterans Following Cardiothoracic Surgery
Actual Study Start Date : November 22, 2017
Actual Primary Completion Date : April 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Recruitment Rate [ Time Frame: Baseline ]
    Recruitment will be expressed as the proportion of eligible patients approached who agree to participate in this pilot study.

  2. Change in Retention Rate [ Time Frame: Baseline, day of surgery, 90 days postoperatively ]
    Retention rate will be expressed as the proportion 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.

  3. Change in Adherence Rate [ Time Frame: Day of surgery, 90 days postoperatively ]
    Compliance rates will be expressed as the proportion of assigned activities actually completed by patients as recorded in home exercise and nutrition logs.

  4. Change in Barriers to Participation over the course of intervention between baseline and day of surgery [ Time Frame: Baseline, day of surgery ]
    Barriers to Participation will be assessed with qualitative interviews exploring potential reasons for refusing participation or adherence with prescribed interventions


Secondary Outcome Measures :
  1. 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 pounds using a Jamar grip dynamometer

  2. Change in Pulmonary Function over the course of treatment and recovery [ Time Frame: Baseline, day of surgery, 90 days postoperatively ]
    Pulmonary function will be measured in terms of maximal inspiratory and expiratory pressures

  3. Change in Nutrition over the course of treatment and recovery [ Time Frame: Baseline, day of surgery, 90 days postoperatively ]
    Nutrition will be measured by serum prealbumin

  4. 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

  5. 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.

  6. 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.

  7. Change in 7-point Subjective Global Assessment 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.

  8. 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.


Other Outcome Measures:
  1. Postoperative Mortality [ Time Frame: 30 and 90 days postoperatively ]
    Vital status after surgery

  2. Postoperative Complications [ Time Frame: 30 days postoperatively ]
    Presence or absence of postoperative complications as defined by the VA Surgical Quality Improvement Program (VASQIP)

  3. Length of Hospital Stay [ Time Frame: 30 days postoperatively ]
    Length of stay as defined by VASQIP

  4. 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

  5. Change in Quality of Surgical Care over the course of treatment and recovery [ Time Frame: Day of Surgery and 30-days postoperatively ]
    AHRQ Surgical Care Survey (SCS)

  6. Change in Living Location over the course of treatment and recovery [ Time Frame: Baseline, day of surgery, 30-days post op, 90-days post op ]
    Living location (e.g., home and independent, home with assistance, assisted living, skilled nursing, nursing home, etc).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Veteran patient scheduled for CABG, valve surgery, or other non-cardiac thoracic surgery;
  2. Demonstrate at least mild frailty (e.g., 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299101


Locations
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United States, Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Daniel E. Hall, MD MDiv MHSc VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03299101    
Other Study ID Numbers: E2562-P
I21RX002562 ( U.S. NIH Grant/Contract )
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
Frailty
Prehabilitation
Exercise therapy
Surgery
Nutrition support
Additional relevant MeSH terms:
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Frailty
Pathologic Processes