Heart rate recovery and morbidity after noncardiac surgery: Planned secondary analysis of two prospective, multi-centre, blinded observational studies.
Gareth L Ackland, Tom E F Abbott, Gary Minto...
https://pubmed.ncbi.nlm.nih.gov/31433825Actively Recruiting
Led by Yale University · Updated on 2026-05-07
371
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are studying whether the SHAPE-HF cardiopulmonary testing system can be used before surgery to better assess heart, lung, and overall physical fitness in adults over 60 years old. This system aims to provide an objective and simplified way to measure aerobic fitness before moderate- to high-risk noncardiac surgery. The study compares this new testing method with traditional ways of estimating fitness, such as patient questionnaires and self-reported activity levels. Participants will attend one in-person visit lasting about 35 minutes during their preoperative evaluation. During this visit, they will complete the SHAPE-HF submaximal exercise test along with standard assessments like the Duke Activity Status Index and subjective metabolic equivalent (MET) evaluations. Around 24 hours after testing, researchers will follow up by phone to check for any issues. After surgery, medical records will be reviewed for 30 days to see how test results relate to recovery, short-term health problems, and major complications. Throughout the study, participants will provide information about their activity levels and undergo testing to measure aerobic fitness objectively. Researchers will assess recruitment success, compare SHAPE-HF results to conventional fitness measures, and track postoperative outcomes including major cardiovascular events and complications. This study does not change planned surgery or care but seeks to improve risk assessment for older adults undergoing moderate- to high-risk surgery.
CONDITIONS
SHAPE Test for Preoperative Risk Stratification
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for pre-surgical evaluation and eligibility assessment
Duration - 1 day
Participants complete a single in-person visit during which conventional preoperative functional assessments and the SHAPE-HF submaximal cardiopulmonary exercise test are performed to objectively assess aerobic fitness before surgery.
1 visit (in-person) lasting approximately 35 minutes during the preoperative period
Duration - 30 days
Participants receive a telephone follow-up approximately 24 hours after testing to assess for any adverse events related to the procedure, followed by postoperative follow-up through medical record review for 30 days after surgery to monitor clinical outcomes.
1 telephone follow-up contact and medical record review over 30 days post-surgery
Total: 1 location
1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
Actively Recruiting
Z
Zyad J Carr, M.D.
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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