ID

40711

Beschrijving

Intra Hemodialytic Oral Protein and Exercise (IHOPE); ODM derived from: https://clinicaltrials.gov/show/NCT01234441

Link

https://clinicaltrials.gov/show/NCT01234441

Trefwoorden

Versies (2)
  1. 01-05-20 01-05-20 -
  2. 02-05-20 02-05-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

2 mei 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Kidney Diseases NCT01234441

Engels

Eligibility Kidney Diseases NCT01234441

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
must receive hemodialysis treatment at least 3 days per week.
Beschrijving

Hemodialysis days per week

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019004
UMLS CUI [1,2]
C0677547
must be ≥ 30 years of age.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
must be willing to be randomized to the control or intervention groups.
Beschrijving

Randomization Control Groups | Randomization Intervention Group

Datatype

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0009932
UMLS CUI [2,1]
C0034656
UMLS CUI [2,2]
C2986530
must be physically able to exercise (e.g., no orthopedic problems that would preclude them from cycling during dialysis).
Beschrijving

Ability Exercise | Orthopedic problem Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0015259
UMLS CUI [2,1]
C0029354
UMLS CUI [2,2]
C0332197
must receive medical clearance from their primary care physician to participate.
Beschrijving

Study Subject Participation Status Approved By Primary Care Physician

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1706842
UMLS CUI [1,3]
C0033131
must be on phosphate binders to control calcium levels.
Beschrijving

Serum Calcium Level Controlled by Phosphate Binders

Datatype

boolean

Alias
UMLS CUI [1,1]
C0036785
UMLS CUI [1,2]
C0332298
UMLS CUI [1,3]
C4020599
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
persistent hemoglobin levels < 10g/dl.
Beschrijving

Hemoglobin level Persistent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019029
UMLS CUI [1,2]
C0205322
weight greater than 300 pounds.
Beschrijving

Body Weight

Datatype

boolean

Alias
UMLS CUI [1]
C0005910
currently receiving any form of intradialytic protein supplementation (oral, enteral, or parenteral) or participating in any form of intradialytic exercise training.
Beschrijving

Protein supplementation During Hemodialysis | Protein supplementation Oral | Protein supplementation Enteral | Protein supplementation Parenteral | Exercise Training During Hemodialysis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0770246
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0019004
UMLS CUI [2,1]
C0770246
UMLS CUI [2,2]
C1527415
UMLS CUI [3,1]
C0770246
UMLS CUI [3,2]
C1522196
UMLS CUI [4,1]
C0770246
UMLS CUI [4,2]
C1518896
UMLS CUI [5,1]
C4279936
UMLS CUI [5,2]
C0347984
UMLS CUI [5,3]
C0019004
chronic obstructive pulmonary disease (copd) and decompensated chronic heart failure (chf).
Beschrijving

Chronic Obstructive Airway Disease | Decompensated chronic heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C1827266
on dialysis treatment for < 3 months (or enrollment may be postponed).
Beschrijving

Dialysis Treatment Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011946
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0449238
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Similar models

Eligibility Kidney Diseases NCT01234441

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Hemodialysis days per week
Item
must receive hemodialysis treatment at least 3 days per week.
boolean
C0019004 (UMLS CUI [1,1])
C0677547 (UMLS CUI [1,2])
Age
Item
must be ≥ 30 years of age.
boolean
C0001779 (UMLS CUI [1])
Randomization Control Groups | Randomization Intervention Group
Item
must be willing to be randomized to the control or intervention groups.
boolean
C0034656 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
C0034656 (UMLS CUI [2,1])
C2986530 (UMLS CUI [2,2])
Ability Exercise | Orthopedic problem Absent
Item
must be physically able to exercise (e.g., no orthopedic problems that would preclude them from cycling during dialysis).
boolean
C0085732 (UMLS CUI [1,1])
C0015259 (UMLS CUI [1,2])
C0029354 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Study Subject Participation Status Approved By Primary Care Physician
Item
must receive medical clearance from their primary care physician to participate.
boolean
C2348568 (UMLS CUI [1,1])
C1706842 (UMLS CUI [1,2])
C0033131 (UMLS CUI [1,3])
Serum Calcium Level Controlled by Phosphate Binders
Item
must be on phosphate binders to control calcium levels.
boolean
C0036785 (UMLS CUI [1,1])
C0332298 (UMLS CUI [1,2])
C4020599 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hemoglobin level Persistent
Item
persistent hemoglobin levels < 10g/dl.
boolean
C0019029 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
Body Weight
Item
weight greater than 300 pounds.
boolean
C0005910 (UMLS CUI [1])
Protein supplementation During Hemodialysis | Protein supplementation Oral | Protein supplementation Enteral | Protein supplementation Parenteral | Exercise Training During Hemodialysis
Item
currently receiving any form of intradialytic protein supplementation (oral, enteral, or parenteral) or participating in any form of intradialytic exercise training.
boolean
C0770246 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0019004 (UMLS CUI [1,3])
C0770246 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0770246 (UMLS CUI [3,1])
C1522196 (UMLS CUI [3,2])
C0770246 (UMLS CUI [4,1])
C1518896 (UMLS CUI [4,2])
C4279936 (UMLS CUI [5,1])
C0347984 (UMLS CUI [5,2])
C0019004 (UMLS CUI [5,3])
Chronic Obstructive Airway Disease | Decompensated chronic heart failure
Item
chronic obstructive pulmonary disease (copd) and decompensated chronic heart failure (chf).
boolean
C0024117 (UMLS CUI [1])
C1827266 (UMLS CUI [2])
Dialysis Treatment Duration
Item
on dialysis treatment for < 3 months (or enrollment may be postponed).
boolean
C0011946 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
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