{
    "info": {
        "nct_id": "NCT04923672",
        "official_title": "Evaluation of the Feasibility of Wearable Technology-Guided Exercise Preconditioning to Accelerate Return to Function After Cancer Surgery",
        "inclusion_criteria": "* Adult (≥ 18 years of age) patients undergoing elective abdominal oncologic resection of a confirmed or potential colorectal, hepatobiliary, or gynecologic neoplasm.\n* Study participants must be able to provide written informed consent and authorization.\n* Study participants must be able to understand written and verbal English, as well as to be able to communicate in English.\n* Study participants must have an Apple iphone to use during the study period\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Any patient unable and/or unwilling to cooperate with all study protocols.\n* Patients who require an assist device (walker) for ambulation.\n* Patients that indicate they did at least 3 days of vigorous intensity activity in the previous 7 days OR any combination of walking, moderate-intensity or vigorous-intensity in all of the last 7 days totaling at least 18 and a half hours\n* Recent history of cardiac disease (within 3 months of registration) that would preclude vigorous exercise\n* Individuals with end stage renal disease currently on dialysis\n* Individuals with a history of liver failure as evidenced by AST, ALT or Alkaline Phosphatase ≥ 3x upper limit of normal\n* Individuals with uncontrolled hypertension\n* Women who are breastfeeding or pregnant\n* American Society of Anesthesiologists Physical Status score ≥ 4\n* Any patient that needs further cardiac evaluation per ACC/AHA perioperative criteria\n* Surgery scheduled < 3 weeks of study registration (precluding time to participate in exercise regimen)\n* Any patient who currently uses a fitness tracker or heart rate monitoring-capable device to guide exercise\n* Patient indicates a lack of familiarity or discomfort with using a smartphone\n* If participation is not in the best interest of the patient, in the opinion of the treating investigator",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Adult (≥ 18 years of age) patients undergoing elective abdominal oncologic resection of a confirmed or potential colorectal, hepatobiliary, or gynecologic neoplasm.",
            "criterions": [
                {
                    "exact_snippets": "Adult (≥ 18 years of age)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "undergoing elective abdominal oncologic resection",
                    "criterion": "procedure",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "elective abdominal oncologic resection"
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed or potential colorectal, hepatobiliary, or gynecologic neoplasm",
                    "criterion": "neoplasm type",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "colorectal",
                                "hepatobiliary",
                                "gynecologic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Study participants must be able to provide written informed consent and authorization.",
            "criterions": [
                {
                    "exact_snippets": "able to provide written informed consent",
                    "criterion": "ability to provide written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "authorization",
                    "criterion": "authorization",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Study participants must be able to understand written and verbal English, as well as to be able to communicate in English.",
            "criterions": [
                {
                    "exact_snippets": "able to understand written and verbal English",
                    "criterion": "English comprehension",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "able to communicate in English",
                    "criterion": "English communication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Study participants must have an Apple iphone to use during the study period",
            "criterions": [
                {
                    "exact_snippets": "Study participants must have an Apple iphone",
                    "criterion": "Apple iPhone",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Any patient unable and/or unwilling to cooperate with all study protocols.",
            "criterions": [
                {
                    "exact_snippets": "unable and/or unwilling to cooperate with all study protocols",
                    "criterion": "cooperation with study protocols",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who require an assist device (walker) for ambulation.",
            "criterions": [
                {
                    "exact_snippets": "require an assist device (walker) for ambulation",
                    "criterion": "assist device for ambulation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients that indicate they did at least 3 days of vigorous intensity activity in the previous 7 days OR any combination of walking, moderate-intensity or vigorous-intensity in all of the last 7 days totaling at least 18 and a half hours",
            "criterions": [
                {
                    "exact_snippets": "Patients that indicate they did at least 3 days of vigorous intensity activity in the previous 7 days",
                    "criterion": "vigorous intensity activity",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "days"
                            }
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "previous 7 days"
                        }
                    ]
                },
                {
                    "exact_snippets": "any combination of walking, moderate-intensity or vigorous-intensity in all of the last 7 days totaling at least 18 and a half hours",
                    "criterion": "physical activity",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "all of the last 7 days"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18.5,
                                "unit": "hours"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recent history of cardiac disease (within 3 months of registration) that would preclude vigorous exercise",
            "criterions": [
                {
                    "exact_snippets": "Recent history of cardiac disease (within 3 months of registration)",
                    "criterion": "recent history of cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac disease ... that would preclude vigorous exercise",
                    "criterion": "cardiac disease impact on exercise",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "precludes vigorous exercise"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Individuals with end stage renal disease currently on dialysis",
            "criterions": [
                {
                    "exact_snippets": "end stage renal disease",
                    "criterion": "end stage renal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "currently on dialysis",
                    "criterion": "dialysis",
                    "requirements": [
                        {
                            "requirement_type": "current status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Individuals with a history of liver failure as evidenced by AST, ALT or Alkaline Phosphatase ≥ 3x upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "history of liver failure",
                    "criterion": "liver failure",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "AST, ALT or Alkaline Phosphatase ≥ 3x upper limit of normal",
                    "criterion": "AST, ALT or Alkaline Phosphatase levels",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "x upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Individuals with uncontrolled hypertension",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women who are breastfeeding or pregnant",
            "criterions": [
                {
                    "exact_snippets": "Women who are ... pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Women who are breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* American Society of Anesthesiologists Physical Status score ≥ 4",
            "criterions": [
                {
                    "exact_snippets": "American Society of Anesthesiologists Physical Status score ≥ 4",
                    "criterion": "American Society of Anesthesiologists Physical Status score",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any patient that needs further cardiac evaluation per ACC/AHA perioperative criteria",
            "criterions": [
                {
                    "exact_snippets": "further cardiac evaluation per ACC/AHA perioperative criteria",
                    "criterion": "cardiac evaluation",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Surgery scheduled < 3 weeks of study registration (precluding time to participate in exercise regimen)",
            "criterions": [
                {
                    "exact_snippets": "Surgery scheduled < 3 weeks of study registration",
                    "criterion": "surgery schedule",
                    "requirements": [
                        {
                            "requirement_type": "time before study registration",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any patient who currently uses a fitness tracker or heart rate monitoring-capable device to guide exercise",
            "criterions": [
                {
                    "exact_snippets": "currently uses a fitness tracker",
                    "criterion": "fitness tracker usage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "heart rate monitoring-capable device",
                    "criterion": "heart rate monitoring-capable device usage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient indicates a lack of familiarity or discomfort with using a smartphone",
            "criterions": [
                {
                    "exact_snippets": "lack of familiarity or discomfort with using a smartphone",
                    "criterion": "smartphone usage",
                    "requirements": [
                        {
                            "requirement_type": "familiarity",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "comfort",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If participation is not in the best interest of the patient, in the opinion of the treating investigator",
            "criterions": [
                {
                    "exact_snippets": "participation is not in the best interest of the patient, in the opinion of the treating investigator",
                    "criterion": "best interest of the patient",
                    "requirements": [
                        {
                            "requirement_type": "opinion",
                            "expected_value": "treating investigator"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}