ID

30959

Description

Supported Treadmill Training for Progressive Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT01339234

Lien

https://clinicaltrials.gov/show/NCT01339234

Mots-clés

Versions (1)
  1. 07/07/2018 07/07/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

7 juillet 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT01339234

Anglais

Eligibility Multiple Sclerosis NCT01339234

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed, written informed consent
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
males or non-pregnant females, 18-60 years of age (inclusive)
Description

Age | Gender Pregnancy Absent

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0032961
UMLS CUI [2,3]
C0332197
clinically definite ppms as per the diagnostic criteria of thompson et al (2000)
Description

Multiple Sclerosis, Primary Progressive

Type de données

boolean

Alias
UMLS CUI [1]
C0751964
expanded disability status score 5.0-8.0 (constant assistance required)
Description

EDSS | Assistance Constant Required

Type de données

boolean

Alias
UMLS CUI [1]
C0451246
UMLS CUI [2,1]
C1269765
UMLS CUI [2,2]
C1948059
UMLS CUI [2,3]
C1514873
body weight <90kg (due to support limitations of treadmill)
Description

Body Weight

Type de données

boolean

Alias
UMLS CUI [1]
C0005910
approval from physician to participate in the exercise program
Description

Participation Exercise Program Approved

Type de données

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0015259
UMLS CUI [1,3]
C3484370
UMLS CUI [1,4]
C0205540
ability to tolerate upright locomotion of the body weight supported treadmill
Description

Locomotion Upright Ability | Body Weight Supported Treadmill

Type de données

boolean

Alias
UMLS CUI [1,1]
C0023946
UMLS CUI [1,2]
C0522015
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C0005910
UMLS CUI [2,2]
C1521721
UMLS CUI [2,3]
C0184069
ability to visit the different sites required for the study
Description

Visit Study Site Different

Type de données

boolean

Alias
UMLS CUI [1,1]
C1512346
UMLS CUI [1,2]
C2347790
UMLS CUI [1,3]
C1705242
ability to commit to 3 weekly training sessions for the duration of 24 weeks
Description

Training Session Quantity Weekly

Type de données

boolean

Alias
UMLS CUI [1,1]
C2673163
UMLS CUI [1,2]
C1883016
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0332174
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any disability acquired from trauma or another illness that could interfere with evaluation of disability due to ms
Description

Disability caused by Trauma | Disability caused by Illness | Interference Evaluation Multiple Sclerosis Disability

Type de données

boolean

Alias
UMLS CUI [1,1]
C0231170
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C3714660
UMLS CUI [2,1]
C0231170
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0221423
UMLS CUI [3,1]
C0521102
UMLS CUI [3,2]
C1261322
UMLS CUI [3,3]
C0026769
UMLS CUI [3,4]
C0231170
any other serious medical condition that might impair the subject's ability to walk on a treadmill and/or participate in aerobic exercise (including but not limited to: documented heart disease or unstable angina, uncontrolled cardiac dysrhythmia, chronic obstructive lung disease, recent non-traumatic fracture, osteoporosis and severe skin ulcerations)
Description

Other medical condition Serious | Impairment Able to walk Treadmill | Impairment Participation Aerobic Exercise | Heart Disease | Angina, Unstable | Cardiac Arrhythmia Uncontrolled | Chronic Obstructive Airway Disease | Nontraumatic fracture | Osteoporosis | Skin Ulcer Severe

Type de données

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0221099
UMLS CUI [2,2]
C2712089
UMLS CUI [2,3]
C0184069
UMLS CUI [3,1]
C0221099
UMLS CUI [3,2]
C0679823
UMLS CUI [3,3]
C0001701
UMLS CUI [4]
C0018799
UMLS CUI [5]
C0002965
UMLS CUI [6,1]
C0003811
UMLS CUI [6,2]
C0205318
UMLS CUI [7]
C0024117
UMLS CUI [8]
C4295197
UMLS CUI [9]
C0029456
UMLS CUI [10,1]
C0037299
UMLS CUI [10,2]
C0205082
female patients who do not agree to use effective contraceptive method(s) during the study
Description

Gender Contraceptive methods Unwilling

Type de données

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
current use or use within the last 2 months of any on- or off-label disease-modifying therapy including ifn-β, glatiramer acetate, iv steroids, mitoxantrone, azathioprine, and cyclophosphamide
Description

Biological Response Modifiers | Interferon-beta | glatiramer acetate | Intravenous steroids | Mitoxantrone | Azathioprine | Cyclophosphamide

Type de données

boolean

Alias
UMLS CUI [1]
C0005525
UMLS CUI [2]
C0015980
UMLS CUI [3]
C0289884
UMLS CUI [4]
C0563322
UMLS CUI [5]
C0026259
UMLS CUI [6]
C0004482
UMLS CUI [7]
C0010583
previous experience with supported treadmill training
Description

Experience Treadmill Training Supported

Type de données

boolean

Alias
UMLS CUI [1,1]
C0237607
UMLS CUI [1,2]
C0184069
UMLS CUI [1,3]
C2673163
UMLS CUI [1,4]
C1521721
kidney disease, peripheral vascular disease or poor circulation
Description

Kidney Disease | Peripheral Vascular Disease | Circulation Poor

Type de données

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0085096
UMLS CUI [3,1]
C0005775
UMLS CUI [3,2]
C0542537
inability to undergo mri or mri with gadolinium administration
Description

MRI Receive Unable | MRI Gadolinium Receive Unable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0024485
UMLS CUI [2,2]
C0016911
UMLS CUI [2,3]
C1514756
UMLS CUI [2,4]
C1299582
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Similar models

Eligibility Multiple Sclerosis NCT01339234

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
signed, written informed consent
boolean
C0021430 (UMLS CUI [1])
Age | Gender Pregnancy Absent
Item
males or non-pregnant females, 18-60 years of age (inclusive)
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Multiple Sclerosis, Primary Progressive
Item
clinically definite ppms as per the diagnostic criteria of thompson et al (2000)
boolean
C0751964 (UMLS CUI [1])
EDSS | Assistance Constant Required
Item
expanded disability status score 5.0-8.0 (constant assistance required)
boolean
C0451246 (UMLS CUI [1])
C1269765 (UMLS CUI [2,1])
C1948059 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
Body Weight
Item
body weight <90kg (due to support limitations of treadmill)
boolean
C0005910 (UMLS CUI [1])
Participation Exercise Program Approved
Item
approval from physician to participate in the exercise program
boolean
C0679823 (UMLS CUI [1,1])
C0015259 (UMLS CUI [1,2])
C3484370 (UMLS CUI [1,3])
C0205540 (UMLS CUI [1,4])
Locomotion Upright Ability | Body Weight Supported Treadmill
Item
ability to tolerate upright locomotion of the body weight supported treadmill
boolean
C0023946 (UMLS CUI [1,1])
C0522015 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0005910 (UMLS CUI [2,1])
C1521721 (UMLS CUI [2,2])
C0184069 (UMLS CUI [2,3])
Visit Study Site Different
Item
ability to visit the different sites required for the study
boolean
C1512346 (UMLS CUI [1,1])
C2347790 (UMLS CUI [1,2])
C1705242 (UMLS CUI [1,3])
Training Session Quantity Weekly
Item
ability to commit to 3 weekly training sessions for the duration of 24 weeks
boolean
C2673163 (UMLS CUI [1,1])
C1883016 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0332174 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Disability caused by Trauma | Disability caused by Illness | Interference Evaluation Multiple Sclerosis Disability
Item
any disability acquired from trauma or another illness that could interfere with evaluation of disability due to ms
boolean
C0231170 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C3714660 (UMLS CUI [1,3])
C0231170 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0221423 (UMLS CUI [2,3])
C0521102 (UMLS CUI [3,1])
C1261322 (UMLS CUI [3,2])
C0026769 (UMLS CUI [3,3])
C0231170 (UMLS CUI [3,4])
Other medical condition Serious | Impairment Able to walk Treadmill | Impairment Participation Aerobic Exercise | Heart Disease | Angina, Unstable | Cardiac Arrhythmia Uncontrolled | Chronic Obstructive Airway Disease | Nontraumatic fracture | Osteoporosis | Skin Ulcer Severe
Item
any other serious medical condition that might impair the subject's ability to walk on a treadmill and/or participate in aerobic exercise (including but not limited to: documented heart disease or unstable angina, uncontrolled cardiac dysrhythmia, chronic obstructive lung disease, recent non-traumatic fracture, osteoporosis and severe skin ulcerations)
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0221099 (UMLS CUI [2,1])
C2712089 (UMLS CUI [2,2])
C0184069 (UMLS CUI [2,3])
C0221099 (UMLS CUI [3,1])
C0679823 (UMLS CUI [3,2])
C0001701 (UMLS CUI [3,3])
C0018799 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0003811 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C0024117 (UMLS CUI [7])
C4295197 (UMLS CUI [8])
C0029456 (UMLS CUI [9])
C0037299 (UMLS CUI [10,1])
C0205082 (UMLS CUI [10,2])
Gender Contraceptive methods Unwilling
Item
female patients who do not agree to use effective contraceptive method(s) during the study
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Biological Response Modifiers | Interferon-beta | glatiramer acetate | Intravenous steroids | Mitoxantrone | Azathioprine | Cyclophosphamide
Item
current use or use within the last 2 months of any on- or off-label disease-modifying therapy including ifn-β, glatiramer acetate, iv steroids, mitoxantrone, azathioprine, and cyclophosphamide
boolean
C0005525 (UMLS CUI [1])
C0015980 (UMLS CUI [2])
C0289884 (UMLS CUI [3])
C0563322 (UMLS CUI [4])
C0026259 (UMLS CUI [5])
C0004482 (UMLS CUI [6])
C0010583 (UMLS CUI [7])
Experience Treadmill Training Supported
Item
previous experience with supported treadmill training
boolean
C0237607 (UMLS CUI [1,1])
C0184069 (UMLS CUI [1,2])
C2673163 (UMLS CUI [1,3])
C1521721 (UMLS CUI [1,4])
Kidney Disease | Peripheral Vascular Disease | Circulation Poor
Item
kidney disease, peripheral vascular disease or poor circulation
boolean
C0022658 (UMLS CUI [1])
C0085096 (UMLS CUI [2])
C0005775 (UMLS CUI [3,1])
C0542537 (UMLS CUI [3,2])
MRI Receive Unable | MRI Gadolinium Receive Unable
Item
inability to undergo mri or mri with gadolinium administration
boolean
C0024485 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0024485 (UMLS CUI [2,1])
C0016911 (UMLS CUI [2,2])
C1514756 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
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