Frailty Clinical Trial
Official title:
Pilot Testing a Home-based Rehabilitation Intervention Designed to Improve Outcomes of Frail Veterans Following Cardiothoracic Surgery
Verified date | December 2020 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
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 |
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