ID

31539

Description

A Trial to Determine the Effects of Exercise in Inflammatory Bowel Disease and Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02463916 Sponsor: University College Cork Information provided by (Responsible Party): Professor Fergus Shanahan, Professor and Chair Department of Medicine and Director Alimentary Pharmabiotic Centre, University College Cork, University College Cork Principal Investigator: Fergus Shanahan, MD, DSc. Professor and Chair Dept. of Medicine, University College Cork

Link

https://clinicaltrials.gov/show/NCT02463916

Keywords

Versions (3)
  1. 8/31/18 8/31/18 -
  2. 9/3/18 9/3/18 - Sarah Riepenhausen
  3. 9/3/18 9/3/18 - Sarah Riepenhausen
Copyright Holder

Professor Fergus Shanahan, Professor and Chair Department of Medicine and Director Alimentary Pharmabiotic Centre, University College Cork, University College Cork

Uploaded on

September 3, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Inflammatory Bowel Disease and Rheumatoid Arthritis NCT02463916

English

Eligibility Inflammatory Bowel Disease and Rheumatoid Arthritis NCT02463916

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 - 40 year-old male and females
Description

Age and Gender

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
bmi between 22 and 35
Description

Bmi between 22 and 35

Data type

boolean

Alias
UMLS CUI [1]
C1305855
confirmed diagnosis of crohn's disease, ulcerative colitis or rheumatoid arthritis
Description

Confirmed diagnosis of crohn's disease, ulcerative colitis or rheumatoid arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0009324
UMLS CUI [2]
C0010346
UMLS CUI [3]
C0003873
currently inactive i.e. no involvement in regular organized physical activity and with low weekly physical activity levels - as defined by the international physical activity questionnaire (ipaq)
Description

Current inactivity according to the international physical activity questionnaire (ipaq)

Data type

boolean

Alias
UMLS CUI [1,1]
C3890554
UMLS CUI [1,2]
C4319956
no regular organized physical activity in the last month
Description

Lack of organized physical activity

Data type

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0015259
subject is willing to comply thoroughly with the basic, standard requirements of the training program
Description

Willingness to comply with the requirements of the training program

Data type

boolean

Alias
UMLS CUI [1]
C1321605
subject is willing to refrain from taking any unspecified dietary, probiotics, multivitamin or herbal supplements (14-day washout period pre-commencement of exercise program)
Description

No unspecified dietary, probiotics, multivitamin or herbal supplements during study

Data type

boolean

Alias
UMLS CUI [1,1]
C0600109
UMLS CUI [1,2]
C1706472
UMLS CUI [1,3]
C0242295
UMLS CUI [2,1]
C1706472
UMLS CUI [2,2]
C1504473
UMLS CUI [3,1]
C1706472
UMLS CUI [3,2]
C0681579
UMLS CUI [4,1]
C1706472
UMLS CUI [4,2]
C0525033
participant is happy to confine their formal exercise to within the mardyke arena
Description

Confinement of formal exercise to within the mardyke arena

Data type

boolean

Alias
UMLS CUI [1,1]
C0015259
UMLS CUI [1,2]
C0450429
UMLS CUI [1,3]
C0443288
deemed to be fit to participate in exercise program for 8 weeks by the study investigators
Description

Deemed to be fit for participation in the study exercise program

Data type

boolean

Alias
UMLS CUI [1,1]
C1282472
UMLS CUI [1,2]
C0015259
UMLS CUI [1,3]
C0008961
UMLS CUI [1,4]
C0871010
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of coronary artery disease, congenital heart disease or any cardiovascular disease, including a family history of coronary artery disease before 45 years of age
Description

History of cardiac diseases including severe family history

Data type

boolean

Alias
UMLS CUI [1]
C0559157
UMLS CUI [2]
C1956346
UMLS CUI [3]
C0152021
UMLS CUI [4,1]
C0241889
UMLS CUI [4,2]
C1956346
UMLS CUI [4,3]
C0001779
uncontrolled hypertension (>140/90mmhg) (not white coat)
Description

uncontrolled hypertesion

Data type

boolean

Alias
UMLS CUI [1]
C1868885
course of antibiotics or bowel preparation for endoscopy one month prior to the commencement of the exercise program
Description

Recent course of antibiotics or bowel preparation for endoscopy

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0455052
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0003232
psychiatric disorders
Description

Psychiatric disorders

Data type

boolean

Alias
UMLS CUI [1]
C0004936
any medical condition deemed exclusionary by the principle investigator
Description

Medical condition deemed exclusionary

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1710101
UMLS CUI [1,3]
C0871010
a history of substance abuse
Description

History of substance abuse

Data type

boolean

Alias
UMLS CUI [1]
C1299544
history of total colectomy
Description

History of total colectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0192871
currently treated with high dose corticosteroids or disease flare within 2 weeks of starting exercise program
Description

Current treatment with high dose corticosteroids or disease flare

Data type

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0035020
UMLS CUI [2,1]
C0521116
UMLS CUI [2,2]
C0444956
UMLS CUI [2,3]
C0239126
pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
history of faecal incontinence
Description

history of faecal incontinence

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0015732
have a malignant disease or any concomitant end stage organ disease
Description

Concomitant end stage organ disease or malignant disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0243087
UMLS CUI [1,2]
C0679247
UMLS CUI [2,1]
C0243087
UMLS CUI [2,2]
C0006826
patients may not be receiving any experimental drug or have been involved in a recent experimental trial in the last 30 days
Description

Current use of any experimental drug or recent involvement in an experimental trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C2348568
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0521116
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Similar models

Eligibility Inflammatory Bowel Disease and Rheumatoid Arthritis NCT02463916

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age and Gender
Item
18 - 40 year-old male and females
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Bmi between 22 and 35
Item
bmi between 22 and 35
boolean
C1305855 (UMLS CUI [1])
Confirmed diagnosis of crohn's disease, ulcerative colitis or rheumatoid arthritis
Item
confirmed diagnosis of crohn's disease, ulcerative colitis or rheumatoid arthritis
boolean
C0009324 (UMLS CUI [1])
C0010346 (UMLS CUI [2])
C0003873 (UMLS CUI [3])
Current inactivity according to the international physical activity questionnaire (ipaq)
Item
currently inactive i.e. no involvement in regular organized physical activity and with low weekly physical activity levels - as defined by the international physical activity questionnaire (ipaq)
boolean
C3890554 (UMLS CUI [1,1])
C4319956 (UMLS CUI [1,2])
Lack of organized physical activity
Item
no regular organized physical activity in the last month
boolean
C1298908 (UMLS CUI [1,1])
C0015259 (UMLS CUI [1,2])
Willingness to comply with the requirements of the training program
Item
subject is willing to comply thoroughly with the basic, standard requirements of the training program
boolean
C1321605 (UMLS CUI [1])
No unspecified dietary, probiotics, multivitamin or herbal supplements during study
Item
subject is willing to refrain from taking any unspecified dietary, probiotics, multivitamin or herbal supplements (14-day washout period pre-commencement of exercise program)
boolean
C0600109 (UMLS CUI [1,1])
C1706472 (UMLS CUI [1,2])
C0242295 (UMLS CUI [1,3])
C1706472 (UMLS CUI [2,1])
C1504473 (UMLS CUI [2,2])
C1706472 (UMLS CUI [3,1])
C0681579 (UMLS CUI [3,2])
C1706472 (UMLS CUI [4,1])
C0525033 (UMLS CUI [4,2])
Confinement of formal exercise to within the mardyke arena
Item
participant is happy to confine their formal exercise to within the mardyke arena
boolean
C0015259 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0443288 (UMLS CUI [1,3])
Deemed to be fit for participation in the study exercise program
Item
deemed to be fit to participate in exercise program for 8 weeks by the study investigators
boolean
C1282472 (UMLS CUI [1,1])
C0015259 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C0871010 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
History of cardiac diseases including severe family history
Item
history of coronary artery disease, congenital heart disease or any cardiovascular disease, including a family history of coronary artery disease before 45 years of age
boolean
C0559157 (UMLS CUI [1])
C1956346 (UMLS CUI [2])
C0152021 (UMLS CUI [3])
C0241889 (UMLS CUI [4,1])
C1956346 (UMLS CUI [4,2])
C0001779 (UMLS CUI [4,3])
uncontrolled hypertesion
Item
uncontrolled hypertension (>140/90mmhg) (not white coat)
boolean
C1868885 (UMLS CUI [1])
Recent course of antibiotics or bowel preparation for endoscopy
Item
course of antibiotics or bowel preparation for endoscopy one month prior to the commencement of the exercise program
boolean
C0332185 (UMLS CUI [1,1])
C0455052 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0003232 (UMLS CUI [2,2])
Psychiatric disorders
Item
psychiatric disorders
boolean
C0004936 (UMLS CUI [1])
Medical condition deemed exclusionary
Item
any medical condition deemed exclusionary by the principle investigator
boolean
C1301624 (UMLS CUI [1,1])
C1710101 (UMLS CUI [1,2])
C0871010 (UMLS CUI [1,3])
History of substance abuse
Item
a history of substance abuse
boolean
C1299544 (UMLS CUI [1])
History of total colectomy
Item
history of total colectomy
boolean
C0231290 (UMLS CUI [1,1])
C0192871 (UMLS CUI [1,2])
Current treatment with high dose corticosteroids or disease flare
Item
currently treated with high dose corticosteroids or disease flare within 2 weeks of starting exercise program
boolean
C0521116 (UMLS CUI [1,1])
C0035020 (UMLS CUI [1,2])
C0521116 (UMLS CUI [2,1])
C0444956 (UMLS CUI [2,2])
C0239126 (UMLS CUI [2,3])
Pregnancy
Item
pregnant
boolean
C0032961 (UMLS CUI [1])
history of faecal incontinence
Item
history of faecal incontinence
boolean
C0262926 (UMLS CUI [1,1])
C0015732 (UMLS CUI [1,2])
Concomitant end stage organ disease or malignant disease
Item
have a malignant disease or any concomitant end stage organ disease
boolean
C0243087 (UMLS CUI [1,1])
C0679247 (UMLS CUI [1,2])
C0243087 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
Current use of any experimental drug or recent involvement in an experimental trial
Item
patients may not be receiving any experimental drug or have been involved in a recent experimental trial in the last 30 days
boolean
C0332185 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
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