{
"info": {
"nct_id": "NCT03029182",
"official_title": "Simulated-Altitude as an Adjunct to Optimize Aerobic Exercise in Obese Breast Cancer Survivors With Limited Ambulatory Function: Pilot Randomized Trial",
"inclusion_criteria": "1. Physician's medical clearance for participation\n2. English-speaking women\n3. 18-70 years of age with a history of Stage 0-III breast cancer\n4. Preferred walking speed of less than 2.9 mph as measured by a timed 10 meter walk test (to be performed on-site after consent during preliminary screening) \"OR\" the inability to complete a 6-minute walk without stopping (to be performed on-site after consent during preliminary screening)\n5. Body mass index between 30-45 kg/m2\n6. ≥1 year post-treatment and not currently receiving or planning to receive chemo/radiation therapies\n7. Not participating in a structured exercise routine\n8. In the previous 6 months, not engaging in (on average) ≥60 minutes of moderate or ≥30 minutes of vigorous physical activity per week.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
"exclusion_criteria": "1. Males\n2. Dementia\n3. Medical, psychological, and/or social characteristics that may interfere with the ability to fully participate in the proposed study activities/assessments (e.g., psychosis, schizophrenia)\n4. Contraindication to participate in regular exercise training\n5. Unwilling to complete prescribed exercise\n6. Inability to walk\n7. Pregnant\n8. Resting oxygen saturation via pulse oximetry below 90%\n9. Using home oxygen therapy",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. Physician's medical clearance for participation",
"criterions": [
{
"exact_snippets": "Physician's medical clearance",
"criterion": "medical clearance",
"requirements": [
{
"requirement_type": "authorization",
"expected_value": true
}
]
}
]
},
{
"line": "2. English-speaking women",
"criterions": [
{
"exact_snippets": "English-speaking",
"criterion": "language",
"requirements": [
{
"requirement_type": "proficiency",
"expected_value": "English"
}
]
},
{
"exact_snippets": "women",
"criterion": "gender",
"requirements": [
{
"requirement_type": "identity",
"expected_value": "female"
}
]
}
]
},
{
"line": "3. 18-70 years of age with a history of Stage 0-III breast cancer",
"criterions": [
{
"exact_snippets": "18-70 years of age",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 70,
"unit": "years"
}
]
}
}
]
},
{
"exact_snippets": "history of Stage 0-III breast cancer",
"criterion": "breast cancer",
"requirements": [
{
"requirement_type": "stage",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "stage"
},
{
"operator": "<=",
"value": 3,
"unit": "stage"
}
]
}
}
]
}
]
},
{
"line": "4. Preferred walking speed of less than 2.9 mph as measured by a timed 10 meter walk test (to be performed on-site after consent during preliminary screening) \"OR\" the inability to complete a 6-minute walk without stopping (to be performed on-site after consent during preliminary screening)",
"criterions": [
{
"exact_snippets": "Preferred walking speed of less than 2.9 mph",
"criterion": "preferred walking speed",
"requirements": [
{
"requirement_type": "speed",
"expected_value": {
"operator": "<",
"value": 2.9,
"unit": "mph"
}
}
]
},
{
"exact_snippets": "inability to complete a 6-minute walk without stopping",
"criterion": "ability to complete a 6-minute walk without stopping",
"requirements": [
{
"requirement_type": "ability",
"expected_value": false
}
]
}
]
},
{
"line": "5. Body mass index between 30-45 kg/m2",
"criterions": [
{
"exact_snippets": "Body mass index between 30-45 kg/m2",
"criterion": "body mass index",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 30,
"unit": "kg/m2"
},
{
"operator": "<=",
"value": 45,
"unit": "kg/m2"
}
]
}
}
]
}
]
},
{
"line": "6. ≥1 year post-treatment and not currently receiving or planning to receive chemo/radiation therapies",
"criterions": [
{
"exact_snippets": "≥1 year post-treatment",
"criterion": "post-treatment duration",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "year"
}
}
]
},
{
"exact_snippets": "not currently receiving ... chemo/radiation therapies",
"criterion": "current chemo/radiation therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "not ... planning to receive chemo/radiation therapies",
"criterion": "planned chemo/radiation therapy",
"requirements": [
{
"requirement_type": "intention",
"expected_value": false
}
]
}
]
},
{
"line": "7. Not participating in a structured exercise routine",
"criterions": [
{
"exact_snippets": "Not participating in a structured exercise routine",
"criterion": "structured exercise routine",
"requirements": [
{
"requirement_type": "participation",
"expected_value": false
}
]
}
]
},
{
"line": "8. In the previous 6 months, not engaging in (on average) ≥60 minutes of moderate or ≥30 minutes of vigorous physical activity per week.",
"criterions": [
{
"exact_snippets": "In the previous 6 months, not engaging in (on average) ≥60 minutes of moderate ... physical activity per week.",
"criterion": "moderate physical activity",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": "<",
"value": 60,
"unit": "minutes per week"
}
}
]
},
{
"exact_snippets": "In the previous 6 months, not engaging in (on average) ... ≥30 minutes of vigorous physical activity per week.",
"criterion": "vigorous physical activity",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": "<",
"value": 30,
"unit": "minutes per week"
}
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "female"
}
]
}
]
},
{
"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"
}
}
]
}
]
},
{
"line": "Must have maximum age of 70 Years",
"criterions": [
{
"exact_snippets": "maximum age of 70 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 70,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "1. Males",
"criterions": [
{
"exact_snippets": "Males",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "male"
}
]
}
]
},
{
"line": "2. Dementia",
"criterions": [
{
"exact_snippets": "Dementia",
"criterion": "dementia",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "3. Medical, psychological, and/or social characteristics that may interfere with the ability to fully participate in the proposed study activities/assessments (e.g., psychosis, schizophrenia)",
"criterions": [
{
"exact_snippets": "Medical, psychological, and/or social characteristics that may interfere with the ability to fully participate",
"criterion": "interference with study participation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "psychosis",
"criterion": "psychosis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "schizophrenia",
"criterion": "schizophrenia",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "4. Contraindication to participate in regular exercise training",
"criterions": [
{
"exact_snippets": "Contraindication to participate in regular exercise training",
"criterion": "contraindication to exercise",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "5. Unwilling to complete prescribed exercise",
"criterions": [
{
"exact_snippets": "Unwilling to complete prescribed exercise",
"criterion": "willingness to complete prescribed exercise",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": false
}
]
}
]
},
{
"line": "6. Inability to walk",
"criterions": [
{
"exact_snippets": "Inability to walk",
"criterion": "ability to walk",
"requirements": [
{
"requirement_type": "ability",
"expected_value": false
}
]
}
]
},
{
"line": "7. Pregnant",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "status",
"expected_value": false
}
]
}
]
},
{
"line": "8. Resting oxygen saturation via pulse oximetry below 90%",
"criterions": [
{
"exact_snippets": "Resting oxygen saturation via pulse oximetry below 90%",
"criterion": "resting oxygen saturation",
"requirements": [
{
"requirement_type": "measurement",
"expected_value": {
"operator": "<",
"value": 90,
"unit": "%"
}
}
]
}
]
},
{
"line": "9. Using home oxygen therapy",
"criterions": [
{
"exact_snippets": "Using home oxygen therapy",
"criterion": "home oxygen therapy",
"requirements": [
{
"requirement_type": "usage",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}