A Feasibility Study of the SHAPE™ Test of Aerobic Fitness in Older Adults Presenting for Moderate to High-risk Surgery
Yale University
Summary
This study is looking at whether a simplified exercise test called the SHAPE-HF cardiopulmonary testing system can be used before surgery in older adults. Doctors often need to know how well a patient's heart, lungs, and body handle physical activity before moderate- to high-risk surgery. This information may help them better understand a patient's fitness for surgery and possible risk of complications afterward. The study will enroll adults older than 60 years who are being evaluated before planned moderate- to high-risk noncardiac surgery. The first goal is to determine if this was feasible in older adults and to learn whether patients can be successfully recruited to complete this pre-surgery test. Secondly, the study will also look at how results from the SHAPE-HF system compare with common ways doctors now estimate fitness, such as asking patients about their physical activity and using a standard questionnaire. Participants will attend one in-person study visit lasting about 35 minutes. During that visit, they will answer questions about their activity level and complete testing with the SHAPE-HF system. The test uses short periods of lower-intensity exercise to estimate aerobic fitness. After the visit, participants will be contacted by phone about 24 hours later to check for any problems related to the study test. Lastly, researchers will also review information from the medical record for 30 days after surgery to see whether test results are related to recovery, short-term health problems after surgery, or major complications. No extra surgery or change in planned medical care is part of this study. The information learned may help improve how doctors evaluate older adults before surgery in the future.
Description
Preoperative functional capacity is a central component of perioperative risk assessment in older adults undergoing moderate- to high-risk surgery. Reduced cardiopulmonary reserve is associated with increased postoperative morbidity, prolonged recovery, and major adverse cardiovascular events, yet functional capacity in routine practice is often estimated using subjective measures such as self-reported activity tolerance, MET estimates, and questionnaire-based assessment. These tools are practical but may misclassify physiologic fitness, particularly in older adults who report acceptable activ…
Eligibility
- Age range
- 60+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Aged \>60 years * Scheduled for pre-surgical evaluation for moderate to high-risk surgical procedure. * RCRI \<2 based on screening of preoperative co-morbidities. * Provision of signed and dated informed consent form Exclusion Criteria: 1. Age \<60 years old 2. Subjective METS \<4 3. Inability to give independent informed consent 4. Revised Cardiac Risk Index (RCRI) \>2 5. Neurological impairment with motor limitations 6. Mental impairment leading to inability to cooperate 7. Recent NSTEMI or STEMI type myocardial infarction (within 6 months) 8. Angina (stable or unst…
Interventions
- DeviceShape II
cardiopulmonary exercise testing apparatus
Location
- Yale New Haven HospitalNew Haven, Connecticut