ID

43719

Description

Trial of Combined Aerobic and Resistance Exercise in Breast Cancer Survivors; ODM derived from: https://clinicaltrials.gov/show/NCT00249015

Link

https://clinicaltrials.gov/show/NCT00249015

Keywords

Versions (3)
  1. 10/2/17 10/2/17 -
  2. 10/4/17 10/4/17 -
  3. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00249015

English

Eligibility Breast Cancer NCT00249015

1 forms  
Criteria
Description

Criteria

are scheduled to receive adjuvant chemotherapy (receiving neoadjuvant chemotherapy for locally advanced cancer is an exclusion criteria)
Description

Adjuvant Chemotherapy Scheduled | Exclusion Criteria Neoadjuvant chemotherapy for malignant neoplasm Advanced Locally

Data type

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C4272610
UMLS CUI [2,3]
C0205179
UMLS CUI [2,4]
C1517927
have not received previous chemotherapy (previous cancer is not an exclusion criteria)
Description

Prior Chemotherapy Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C2828389
have not received transabdominal rectus abdominis muscle (tram) reconstructive surgery
Description

Breast reconstruction with TRAM flap Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C1960508
UMLS CUI [1,2]
C2828389
are 18 years or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
received approval from their treating oncologist
Description

Approval Oncologist Treating

Data type

boolean

Alias
UMLS CUI [1,1]
C2346845
UMLS CUI [1,2]
C0259990
UMLS CUI [1,3]
C1522326
no uncontrolled hypertension, cardiac illness or psychiatric condition or any other medical condition that would be a contraindication to exercise
Description

Exclusion Criteria | Uncontrolled hypertension | Heart Diseases | Mental disorders | Medical contraindication Exercise

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C1868885
UMLS CUI [3]
C0018799
UMLS CUI [4]
C0004936
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0015259
able to understand and provide written informed consent in english or french (ottawa)
Description

Informed Consent English Language | Informed Consent French language

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0376246
complete maximal aerobic and strength tests. no contraindication to exercise as determined by fitness tests
Description

Aerobic ExerciseTest Maximal Complete | Strength Training Test Maximal Complete | Medical contraindication Absent Exercise | Fitness Testing

Data type

boolean

Alias
UMLS CUI [1,1]
C0001701
UMLS CUI [1,2]
C0039593
UMLS CUI [1,3]
C0205289
UMLS CUI [1,4]
C0205197
UMLS CUI [2,1]
C0872279
UMLS CUI [2,2]
C0039593
UMLS CUI [2,3]
C0205289
UMLS CUI [2,4]
C0205197
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0015259
UMLS CUI [4]
C4279962
are not pregnant
Description

Pregnancy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
willing to accept randomization and complete their assigned exercise program
Description

Randomization | Exercise program Completion

Data type

boolean

Alias
UMLS CUI [1]
C0034656
UMLS CUI [2,1]
C1562786
UMLS CUI [2,2]
C0205197
if participant is currently exercising (e.g., swimming at the y 3 times per week) must be willing to give this up in place of their randomly assigned program
Description

Exercise Discontinue | Swimming Frequency Discontinue | Exercise program Random assignment

Data type

boolean

Alias
UMLS CUI [1,1]
C0015259
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C0039003
UMLS CUI [2,2]
C0439603
UMLS CUI [2,3]
C1444662
UMLS CUI [3,1]
C1562786
UMLS CUI [3,2]
C0814868
willing to travel to fitness center 3 times/week to complete exercise program
Description

Travel Frequency Fitness Center | Exercise program Completion

Data type

boolean

Alias
UMLS CUI [1,1]
C0040802
UMLS CUI [1,2]
C0439603
UMLS CUI [1,3]
C0600623
UMLS CUI [2,1]
C1562786
UMLS CUI [2,2]
C0205197
willing to complete all assessments (except blood) at all timepoints including 6, 12, and 24 month follow-ups
Description

Assessment All Completion | Exception Blood

Data type

boolean

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C0444868
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0005767
must not have a planned/known absence of greater than 2 weeks during the intended intervention period and must be able/willing to perform exercise sessions on their own during any planned absences of less than 2 weeks
Description

Absence Week Quantity Excluded | Home exercise During Absence

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0439230
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C2828389
UMLS CUI [2,1]
C0475647
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C0332197
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Similar models

Eligibility Breast Cancer NCT00249015

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adjuvant Chemotherapy Scheduled | Exclusion Criteria Neoadjuvant chemotherapy for malignant neoplasm Advanced Locally
Item
are scheduled to receive adjuvant chemotherapy (receiving neoadjuvant chemotherapy for locally advanced cancer is an exclusion criteria)
boolean
C0085533 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2,1])
C4272610 (UMLS CUI [2,2])
C0205179 (UMLS CUI [2,3])
C1517927 (UMLS CUI [2,4])
Prior Chemotherapy Excluded
Item
have not received previous chemotherapy (previous cancer is not an exclusion criteria)
boolean
C1514457 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Breast reconstruction with TRAM flap Excluded
Item
have not received transabdominal rectus abdominis muscle (tram) reconstructive surgery
boolean
C1960508 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Age
Item
are 18 years or older
boolean
C0001779 (UMLS CUI [1])
Approval Oncologist Treating
Item
received approval from their treating oncologist
boolean
C2346845 (UMLS CUI [1,1])
C0259990 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
Exclusion Criteria | Uncontrolled hypertension | Heart Diseases | Mental disorders | Medical contraindication Exercise
Item
no uncontrolled hypertension, cardiac illness or psychiatric condition or any other medical condition that would be a contraindication to exercise
boolean
C0680251 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
C0004936 (UMLS CUI [4])
C1301624 (UMLS CUI [5,1])
C0015259 (UMLS CUI [5,2])
Informed Consent English Language | Informed Consent French language
Item
able to understand and provide written informed consent in english or french (ottawa)
boolean
C0021430 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0376246 (UMLS CUI [2,2])
Aerobic ExerciseTest Maximal Complete | Strength Training Test Maximal Complete | Medical contraindication Absent Exercise | Fitness Testing
Item
complete maximal aerobic and strength tests. no contraindication to exercise as determined by fitness tests
boolean
C0001701 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
C0205289 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
C0872279 (UMLS CUI [2,1])
C0039593 (UMLS CUI [2,2])
C0205289 (UMLS CUI [2,3])
C0205197 (UMLS CUI [2,4])
C1301624 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0015259 (UMLS CUI [3,3])
C4279962 (UMLS CUI [4])
Pregnancy Absent
Item
are not pregnant
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Randomization | Exercise program Completion
Item
willing to accept randomization and complete their assigned exercise program
boolean
C0034656 (UMLS CUI [1])
C1562786 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Exercise Discontinue | Swimming Frequency Discontinue | Exercise program Random assignment
Item
if participant is currently exercising (e.g., swimming at the y 3 times per week) must be willing to give this up in place of their randomly assigned program
boolean
C0015259 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0039003 (UMLS CUI [2,1])
C0439603 (UMLS CUI [2,2])
C1444662 (UMLS CUI [2,3])
C1562786 (UMLS CUI [3,1])
C0814868 (UMLS CUI [3,2])
Travel Frequency Fitness Center | Exercise program Completion
Item
willing to travel to fitness center 3 times/week to complete exercise program
boolean
C0040802 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0600623 (UMLS CUI [1,3])
C1562786 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Assessment All Completion | Exception Blood
Item
willing to complete all assessments (except blood) at all timepoints including 6, 12, and 24 month follow-ups
boolean
C1516048 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0005767 (UMLS CUI [2,2])
Absence Week Quantity Excluded | Home exercise During Absence
Item
must not have a planned/known absence of greater than 2 weeks during the intended intervention period and must be able/willing to perform exercise sessions on their own during any planned absences of less than 2 weeks
boolean
C0332197 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C2828389 (UMLS CUI [1,4])
C0475647 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
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