ID

37362

Beskrivning

The Diabetes Aerobic and Resistance Bands Exercise (DARE-Bands) Trial; ODM derived from: https://clinicaltrials.gov/show/NCT02009995

Länk

https://clinicaltrials.gov/show/NCT02009995

Nyckelord

Versioner (1)
  1. 2019-07-20 2019-07-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 juli 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT02009995

Engelsk

Eligibility Type 2 Diabetes NCT02009995

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. adults aged >35 years with t2d as defined by the cda expert committee.
Beskrivning

Adult | Age | Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0011860
2. a1c values within range of 6.6%-9.9%.
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
3. willingness to follow study procedures (e.g. wear the accelerometer for exercise sessions and download them at least weekly, complete exercise logs, attend supervised group-based resistance band sessions, perform resistance bands exercise at home).
Beskrivning

Protocol Compliance | Use of Accelerometer Exercise | Resistance Training

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0178951
UMLS CUI [2,3]
C0015259
UMLS CUI [3]
C0872279
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. participation in a regular program of physical conditioning or aerobic sports/activities for >150 minutes per week during the 6 months prior to enrolment.
Beskrivning

Exercise Regular | Aerobic Exercise mins/week

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015259
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C0001701
UMLS CUI [2,2]
C0556975
2. participation in any resistance exercise training during the previous 6 months.
Beskrivning

Resistance Training Previous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0872279
UMLS CUI [1,2]
C0205156
3. requirement for insulin therapy currently or in the previous 3 months.
Beskrivning

Requirement Insulin regime

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0557978
4. uncontrolled hyperglycemia (a1c > 10%), as it would be a clear indication for cointervention.
Beskrivning

Hyperglycemia Uncontrolled | Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020456
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0474680
5. uncontrolled hypertension: systolic bp >160 mmhg or diastolic bp >100 mmhg, both measured in sitting position. if too-high a1c or bp is the only reason for exclusion, subjects will be asked to see their physicians regarding the hyperglycemia or bp, and invited to re-apply for the study several months later if the problem is under better control.
Beskrivning

Uncontrolled hypertension | Sitting systolic blood pressure | Sitting diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C1319893
UMLS CUI [3]
C1319894
6. hypo-glycemia unawareness, or severe hypoglycemia requiring assistance from another person within the previous 3 months.
Beskrivning

Loss of hypoglycemic warning | Hypoglycemia Severe Requires assistance

Datatyp

boolean

Alias
UMLS CUI [1]
C0342317
UMLS CUI [2,1]
C0020615
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1269765
7. restrictions in physical activity due to disease: unstable cardiac or pulmonary disease, severe aortic stenosis, marfan's syndrome (risk of aortic dissection from resistance training), intermittent claudication sufficient to interfere with aerobic exercise progression, severe peripheral neuropathy or active proliferative retinopathy, disabling stroke, severe arthritis, musculoskeletal injuries compromising safety of the prescribed exercises, inability to walk 10 minutes.
Beskrivning

Restriction Physical activity Due to Disease | Heart Disease Unstable | Lung disease Unstable | Aortic Stenosis Severe | Marfan Syndrome | Intermittent Claudication | Peripheral Neuropathy Severe | Proliferative retinopathy | Cerebrovascular accident Disabling | Arthritis Severe | Injury of musculoskeletal system | Lacking Able to walk Minutes Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0443288
UMLS CUI [1,2]
C0026606
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0012634
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0024115
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0003507
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C0024796
UMLS CUI [6]
C0021775
UMLS CUI [7,1]
C0031117
UMLS CUI [7,2]
C0205082
UMLS CUI [8]
C0339467
UMLS CUI [9,1]
C0038454
UMLS CUI [9,2]
C4061999
UMLS CUI [10,1]
C0003864
UMLS CUI [10,2]
C0205082
UMLS CUI [11]
C0272448
UMLS CUI [12,1]
C0332268
UMLS CUI [12,2]
C2712089
UMLS CUI [12,3]
C0439232
UMLS CUI [12,4]
C1265611
8. other illness, judged by the patient or study physician to make participation in this study inadvisable.
Beskrivning

Comorbidity Study Subject Participation Status Unfavorable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C3640815
9. inability to understand or comply with instructions.
Beskrivning

Instructions Comprehension Unable | Compliance Instructions Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1442085
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C1442085
UMLS CUI [2,3]
C1299582
10. pregnancy at the start of the study, or intention to become pregnant in the next 6 months.
Beskrivning

Pregnancy | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
11. plans to move to a different city within the next 12 months.
Beskrivning

Relocation of home Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2699029
UMLS CUI [1,2]
C1301732
12. inability to communicate in english or french.
Beskrivning

Lacking Able to communicate English Language | Lacking Able to communicate French language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2364293
UMLS CUI [1,3]
C0376245
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C2364293
UMLS CUI [2,3]
C0376246
13. unwillingness to sign informed consent.
Beskrivning

Informed Consent Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
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Similar models

Eligibility Type 2 Diabetes NCT02009995

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age | Diabetes Mellitus, Non-Insulin-Dependent
Item
1. adults aged >35 years with t2d as defined by the cda expert committee.
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0011860 (UMLS CUI [3])
Hemoglobin A1c measurement
Item
2. a1c values within range of 6.6%-9.9%.
boolean
C0474680 (UMLS CUI [1])
Protocol Compliance | Use of Accelerometer Exercise | Resistance Training
Item
3. willingness to follow study procedures (e.g. wear the accelerometer for exercise sessions and download them at least weekly, complete exercise logs, attend supervised group-based resistance band sessions, perform resistance bands exercise at home).
boolean
C0525058 (UMLS CUI [1])
C1524063 (UMLS CUI [2,1])
C0178951 (UMLS CUI [2,2])
C0015259 (UMLS CUI [2,3])
C0872279 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Exercise Regular | Aerobic Exercise mins/week
Item
1. participation in a regular program of physical conditioning or aerobic sports/activities for >150 minutes per week during the 6 months prior to enrolment.
boolean
C0015259 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0001701 (UMLS CUI [2,1])
C0556975 (UMLS CUI [2,2])
Resistance Training Previous
Item
2. participation in any resistance exercise training during the previous 6 months.
boolean
C0872279 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Requirement Insulin regime
Item
3. requirement for insulin therapy currently or in the previous 3 months.
boolean
C1514873 (UMLS CUI [1,1])
C0557978 (UMLS CUI [1,2])
Hyperglycemia Uncontrolled | Hemoglobin A1c measurement
Item
4. uncontrolled hyperglycemia (a1c > 10%), as it would be a clear indication for cointervention.
boolean
C0020456 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0474680 (UMLS CUI [2])
Uncontrolled hypertension | Sitting systolic blood pressure | Sitting diastolic blood pressure
Item
5. uncontrolled hypertension: systolic bp >160 mmhg or diastolic bp >100 mmhg, both measured in sitting position. if too-high a1c or bp is the only reason for exclusion, subjects will be asked to see their physicians regarding the hyperglycemia or bp, and invited to re-apply for the study several months later if the problem is under better control.
boolean
C1868885 (UMLS CUI [1])
C1319893 (UMLS CUI [2])
C1319894 (UMLS CUI [3])
Loss of hypoglycemic warning | Hypoglycemia Severe Requires assistance
Item
6. hypo-glycemia unawareness, or severe hypoglycemia requiring assistance from another person within the previous 3 months.
boolean
C0342317 (UMLS CUI [1])
C0020615 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1269765 (UMLS CUI [2,3])
Restriction Physical activity Due to Disease | Heart Disease Unstable | Lung disease Unstable | Aortic Stenosis Severe | Marfan Syndrome | Intermittent Claudication | Peripheral Neuropathy Severe | Proliferative retinopathy | Cerebrovascular accident Disabling | Arthritis Severe | Injury of musculoskeletal system | Lacking Able to walk Minutes Quantity
Item
7. restrictions in physical activity due to disease: unstable cardiac or pulmonary disease, severe aortic stenosis, marfan's syndrome (risk of aortic dissection from resistance training), intermittent claudication sufficient to interfere with aerobic exercise progression, severe peripheral neuropathy or active proliferative retinopathy, disabling stroke, severe arthritis, musculoskeletal injuries compromising safety of the prescribed exercises, inability to walk 10 minutes.
boolean
C0443288 (UMLS CUI [1,1])
C0026606 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,4])
C0018799 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0024115 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0003507 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0024796 (UMLS CUI [5])
C0021775 (UMLS CUI [6])
C0031117 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0339467 (UMLS CUI [8])
C0038454 (UMLS CUI [9,1])
C4061999 (UMLS CUI [9,2])
C0003864 (UMLS CUI [10,1])
C0205082 (UMLS CUI [10,2])
C0272448 (UMLS CUI [11])
C0332268 (UMLS CUI [12,1])
C2712089 (UMLS CUI [12,2])
C0439232 (UMLS CUI [12,3])
C1265611 (UMLS CUI [12,4])
Comorbidity Study Subject Participation Status Unfavorable
Item
8. other illness, judged by the patient or study physician to make participation in this study inadvisable.
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
Instructions Comprehension Unable | Compliance Instructions Unable
Item
9. inability to understand or comply with instructions.
boolean
C1442085 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C1442085 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Pregnancy | Pregnancy, Planned
Item
10. pregnancy at the start of the study, or intention to become pregnant in the next 6 months.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Relocation of home Planned
Item
11. plans to move to a different city within the next 12 months.
boolean
C2699029 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Lacking Able to communicate English Language | Lacking Able to communicate French language
Item
12. inability to communicate in english or french.
boolean
C0332268 (UMLS CUI [1,1])
C2364293 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C2364293 (UMLS CUI [2,2])
C0376246 (UMLS CUI [2,3])
Informed Consent Unwilling
Item
13. unwillingness to sign informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
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