{
"info": {
"nct_id": "NCT01236417",
"official_title": "Exercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia",
"inclusion_criteria": "* Post menopausal women with a history of estrogen positive breast cancer who are receiving aromatase inhibitors for at least one month.\n* Patients must complain of mild to moderate arthralgia.\n* Ability to understand and sign informed consent.\n* Patients meet criteria for low to moderate risk for moderate exercise based oon the ACSM guidelines.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Inability to comply with study requirements.\n* Metastatic breast cancer.\n* Patients with orthopedic or neuromuscular disorders that preclude participation in exercise.\n* Rheumatoid arthritis.\n* History of MI, angina or congestive heart failure.\n* Pregnant or lactating females.\n* Patients that are high risk for moderate exercise based on ACSM risk classification.\n* Patients who exceed minimal physical activity recommendations from the US Surgeon General's Report: Accumulation of 30 minutes or more of moderate physical activity on most days of the week.\n* Morbidly obese with BMI ≥ 40",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Post menopausal women with a history of estrogen positive breast cancer who are receiving aromatase inhibitors for at least one month.",
"criterions": [
{
"exact_snippets": [
"Post menopausal women"
],
"criterion": "menopausal status",
"requirement_type": "specific status",
"expected_value": "postmenopausal"
},
{
"exact_snippets": [
"history of estrogen positive breast cancer"
],
"criterion": "estrogen receptor status",
"requirement_type": "specific status",
"expected_value": "positive"
},
{
"exact_snippets": [
"history of estrogen positive breast cancer"
],
"criterion": "breast cancer",
"requirement_type": "history",
"expected_value": true
},
{
"exact_snippets": [
"receiving aromatase inhibitors"
],
"criterion": "aromatase inhibitors",
"requirement_type": "current treatment",
"expected_value": true
},
{
"exact_snippets": [
"for at least one month"
],
"criterion": "duration of aromatase inhibitor treatment",
"requirement_type": "minimum duration",
"expected_value": {
"operator": ">=",
"value": 1
}
}
]
},
{
"line": "* Patients must complain of mild to moderate arthralgia.",
"criterions": [
{
"exact_snippets": [
"mild to moderate arthralgia"
],
"criterion": "arthralgia",
"requirement_type": "severity",
"expected_value": [
"mild",
"moderate"
]
}
]
},
{
"line": "* Ability to understand and sign informed consent.",
"criterions": [
{
"exact_snippets": [
"Ability to understand"
],
"criterion": "understanding",
"requirement_type": "ability",
"expected_value": true
},
{
"exact_snippets": [
"sign informed consent"
],
"criterion": "informed consent",
"requirement_type": "ability to sign",
"expected_value": true
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": [
"Healthy volunteers allowed"
],
"criterion": "healthy volunteers",
"requirement_type": "participation",
"expected_value": true
}
]
},
{
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": [
"Must be FEMALE"
],
"criterion": "gender",
"requirement_type": "specific value",
"expected_value": "female"
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": [
"minimum age of 18 Years"
],
"criterion": "age",
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18
}
}
]
}
],
"exclusion_lines": [
{
"line": "* Inability to comply with study requirements.",
"criterions": [
{
"exact_snippets": [
"Inability to comply with study requirements"
],
"criterion": "compliance with study requirements",
"requirement_type": "ability",
"expected_value": true
}
]
},
{
"line": "* Metastatic breast cancer.",
"criterions": [
{
"exact_snippets": [
"Metastatic breast cancer"
],
"criterion": "breast cancer",
"requirement_type": "metastasis",
"expected_value": true
}
]
},
{
"line": "* Patients with orthopedic or neuromuscular disorders that preclude participation in exercise.",
"criterions": [
{
"exact_snippets": [
"orthopedic or neuromuscular disorders"
],
"criterion": "orthopedic disorders",
"requirement_type": "presence",
"expected_value": true
},
{
"exact_snippets": [
"orthopedic or neuromuscular disorders"
],
"criterion": "neuromuscular disorders",
"requirement_type": "presence",
"expected_value": true
},
{
"exact_snippets": [
"preclude participation in exercise"
],
"criterion": "ability to participate in exercise",
"requirement_type": "ability",
"expected_value": false
}
]
},
{
"line": "* Rheumatoid arthritis.",
"criterions": [
{
"exact_snippets": [
"Rheumatoid arthritis"
],
"criterion": "rheumatoid arthritis",
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"line": "* Pregnant or lactating females.",
"criterions": [
{
"exact_snippets": [
"Pregnant"
],
"criterion": "pregnancy",
"requirement_type": "status",
"expected_value": false
},
{
"exact_snippets": [
"lactating"
],
"criterion": "lactation",
"requirement_type": "status",
"expected_value": false
}
]
},
{
"line": "* Patients that are high risk for moderate exercise based on ACSM risk classification.",
"criterions": [
{
"exact_snippets": [
"high risk for moderate exercise"
],
"criterion": "exercise risk",
"requirement_type": "severity",
"expected_value": "high"
},
{
"exact_snippets": [
"ACSM risk classification"
],
"criterion": "ACSM risk classification",
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"line": "* Patients who exceed minimal physical activity recommendations from the US Surgeon General's Report: Accumulation of 30 minutes or more of moderate physical activity on most days of the week.",
"criterions": [
{
"exact_snippets": [
"exceed minimal physical activity recommendations",
"30 minutes or more of moderate physical activity",
"most days of the week"
],
"criterion": "physical activity",
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 30
}
]
}
},
{
"exact_snippets": [
"most days of the week"
],
"criterion": "physical activity",
"requirement_type": "frequency",
"expected_value": "most days of the week"
}
]
},
{
"line": "* Morbidly obese with BMI ≥ 40",
"criterions": [
{
"exact_snippets": [
"Morbidly obese"
],
"criterion": "obesity",
"requirement_type": "severity",
"expected_value": "morbid"
},
{
"exact_snippets": [
"BMI ≥ 40"
],
"criterion": "BMI",
"requirement_type": "value",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 40
}
]
}
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"line": "* Patients meet criteria for low to moderate risk for moderate exercise based oon the ACSM guidelines.",
"criterions": [
{
"exact_snippets": [
"low to moderate risk for moderate exercise"
],
"criterion": "risk for moderate exercise",
"requirement_type": "level",
"expected_value": [
"low",
"moderate"
]
},
{
"exact_snippets": [
"based on the ACSM guidelines"
],
"criterion": "guidelines",
"requirement_type": "source",
"expected_value": "ACSM"
}
]
}
],
"failed_exclusion": [
{
"line": "* History of MI, angina or congestive heart failure.",
"criterions": [
{
"exact_snippets": [
"History of MI"
],
"criterion": "myocardial infarction",
"requirement_type": "history",
"expected_value": true
},
{
"exact_snippets": [
"History of angina"
],
"criterion": "angina",
"requirement_type": "history",
"expected_value": true
},
{
"exact_snippets": [
"History of congestive heart failure"
],
"criterion": "congestive heart failure",
"requirement_type": "history",
"expected_value": true
}
]
}
],
"failed_miscellaneous": []
}