ID

39280

Description

A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Participants With Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT01065090

Link

https://clinicaltrials.gov/show/NCT01065090

Keywords

Versions (1)
  1. 12/16/19 12/16/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 16, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Exercise NCT01065090

English

Eligibility Exercise NCT01065090

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Exercise NCT01065090
Criteria
Description

Criteria

age > 18 years and age < 65 years at screening
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
relapsing remitting multiple sclerosis (rrms) diagnosis according to mcdonald criteria
Description

Multiple Sclerosis, Relapsing-Remitting

Data type

boolean

Alias
UMLS CUI [1]
C0751967
subjects who have been on avonex treatment for 3-6 months prior to screening
Description

Avonex

Data type

boolean

Alias
UMLS CUI [1]
C0594372
a signed informed consent form (icf) is obtained before any study activity
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
edss > 1.5 and < 5 at screening with at least a score of 1 in pyramidal function
Description

Kurtzke multiple sclerosis rating scale | Pyramidal Tract function Score

Data type

boolean

Alias
UMLS CUI [1]
C0451246
UMLS CUI [2,1]
C0034229
UMLS CUI [2,2]
C0031843
UMLS CUI [2,3]
C0449820
are able to walk at least 100 meters
Description

Able to walk Meter Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C2712089
UMLS CUI [1,2]
C0475209
UMLS CUI [1,3]
C1265611
are able to transport themselves to and from the training facility
Description

Transportation Self Training

Data type

boolean

Alias
UMLS CUI [1,1]
C0040756
UMLS CUI [1,2]
C0036588
UMLS CUI [1,3]
C0220931
key exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
suffer from dementia, alcoholism or if they use pacemaker
Description

Dementia | Alcoholic Intoxication, Chronic | Artificial cardiac pacemaker

Data type

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2]
C0001973
UMLS CUI [3]
C0030163
have any serious medical co-morbidities like cardiovascular, respiratory, orthopedic or metabolic diseases
Description

Comorbidity Serious | Cardiovascular Diseases | Respiration Disorders | Orthopedic disorders | Metabolic Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0035204
UMLS CUI [4]
C2014414
UMLS CUI [5]
C0025517
have had a ms relapse within an eight week period prior to the study start
Description

Multiple sclerosis relapse

Data type

boolean

Alias
UMLS CUI [1]
C0856120
are pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
have trained systematic resistance training for one day or more each week in the prior 3 months before study start.
Description

Resistance Training systematic days per week

Data type

boolean

Alias
UMLS CUI [1,1]
C0872279
UMLS CUI [1,2]
C0220922
UMLS CUI [1,3]
C0677547
only able to participate in less than 70% of the planned training sessions.
Description

Training Percentage Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C0220931
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0205197
suffers from major depression
Description

Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
note: other protocol defined inclusion/exclusion criteria may apply.
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Exercise NCT01065090

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Exercise NCT01065090
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Age
Item
age > 18 years and age < 65 years at screening
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis, Relapsing-Remitting
Item
relapsing remitting multiple sclerosis (rrms) diagnosis according to mcdonald criteria
boolean
C0751967 (UMLS CUI [1])
Avonex
Item
subjects who have been on avonex treatment for 3-6 months prior to screening
boolean
C0594372 (UMLS CUI [1])
Informed Consent
Item
a signed informed consent form (icf) is obtained before any study activity
boolean
C0021430 (UMLS CUI [1])
Kurtzke multiple sclerosis rating scale | Pyramidal Tract function Score
Item
edss > 1.5 and < 5 at screening with at least a score of 1 in pyramidal function
boolean
C0451246 (UMLS CUI [1])
C0034229 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0449820 (UMLS CUI [2,3])
Able to walk Meter Quantity
Item
are able to walk at least 100 meters
boolean
C2712089 (UMLS CUI [1,1])
C0475209 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Transportation Self Training
Item
are able to transport themselves to and from the training facility
boolean
C0040756 (UMLS CUI [1,1])
C0036588 (UMLS CUI [1,2])
C0220931 (UMLS CUI [1,3])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Dementia | Alcoholic Intoxication, Chronic | Artificial cardiac pacemaker
Item
suffer from dementia, alcoholism or if they use pacemaker
boolean
C0497327 (UMLS CUI [1])
C0001973 (UMLS CUI [2])
C0030163 (UMLS CUI [3])
Comorbidity Serious | Cardiovascular Diseases | Respiration Disorders | Orthopedic disorders | Metabolic Diseases
Item
have any serious medical co-morbidities like cardiovascular, respiratory, orthopedic or metabolic diseases
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2])
C0035204 (UMLS CUI [3])
C2014414 (UMLS CUI [4])
C0025517 (UMLS CUI [5])
Multiple sclerosis relapse
Item
have had a ms relapse within an eight week period prior to the study start
boolean
C0856120 (UMLS CUI [1])
Pregnancy
Item
are pregnant
boolean
C0032961 (UMLS CUI [1])
Resistance Training systematic days per week
Item
have trained systematic resistance training for one day or more each week in the prior 3 months before study start.
boolean
C0872279 (UMLS CUI [1,1])
C0220922 (UMLS CUI [1,2])
C0677547 (UMLS CUI [1,3])
Training Percentage Completed
Item
only able to participate in less than 70% of the planned training sessions.
boolean
C0220931 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Major Depressive Disorder
Item
suffers from major depression
boolean
C1269683 (UMLS CUI [1])
Eligibility Criteria Study Protocol
Item
note: other protocol defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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