ID

36782

Beskrivning

High-intensity Exercise and Fall Prevention Boot Camp for Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02230267

Länk

https://clinicaltrials.gov/show/NCT02230267

Nyckelord

Versioner (1)
  1. 2019-06-07 2019-06-07 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

7 juni 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT02230267

Engelsk

Eligibility Parkinson's Disease NCT02230267

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
neurologist-diagnosed idiopathic pd based on the uk pd brain bank criteria
Beskrivning

Parkinson Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0030567
aged 45-85
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
hoehn and yahr stages 1-3 (mild to moderate pd)
Beskrivning

Parkinson Disease Mild Hoehn and Yahr Stage | Parkinson Disease Moderate Hoehn and Yahr Stage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C2945599
UMLS CUI [1,3]
C3639483
UMLS CUI [2,1]
C0030567
UMLS CUI [2,2]
C0205081
UMLS CUI [2,3]
C3639483
participants do not anticipate a change in medication or surgical procedures in the next 8 months of the trial (2 months for the trial and 6 for the follow-up)
Beskrivning

Change of medication Absent | Change Operative Surgical Procedures Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0580105
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0392747
UMLS CUI [2,2]
C0543467
UMLS CUI [2,3]
C0332197
clearance from primary care physician to participate in the trial
Beskrivning

Study Subject Participation Status Approved

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0205540
must be stable on pd medication and dbs for 3 months prior to trial
Beskrivning

Antiparkinson Agents Stable | Deep Brain Stimulation Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0394162
UMLS CUI [2,2]
C0205360
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
poorly controlled or unstable cardiovascular disease that precludes participation in exercise
Beskrivning

Cardiovascular Disease Poorly controlled | Cardiovascular Disease Unstable | Exercise participation Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C3853134
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0015259
UMLS CUI [3,2]
C0679823
UMLS CUI [3,3]
C0332196
moderate-to-severe dementia using the montreal cognitive assessment (moca). we will exclude participants with a moca cut off score of <26/30. this cut off value has excellent sensitivity (90%) and specificity (75%).
Beskrivning

Moderate dementia Montreal cognitive assessment | Severe dementia Montreal cognitive assessment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3494871
UMLS CUI [1,2]
C3496286
UMLS CUI [2,1]
C3494652
UMLS CUI [2,2]
C3496286
inability to stand or walk for more than 10 minutes
Beskrivning

Lacking Able to stand Duration | Lacking Able to walk Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0560884
UMLS CUI [1,3]
C0449238
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C2712089
UMLS CUI [2,3]
C0449238
other significant disorders that would limit endurance exercise participation (i.e., osteoarthritis, stroke, respiratory problems, traumatic brain injury, neuromuscular disease, pain)
Beskrivning

Disease Limiting Exercise | Osteoarthritis | Cerebrovascular accident | Respiratory problem | Traumatic Brain Injury | Neuromuscular Diseases | Pain

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0015259
UMLS CUI [2]
C0029408
UMLS CUI [3]
C0038454
UMLS CUI [4]
C1659989
UMLS CUI [5]
C0876926
UMLS CUI [6]
C0027868
UMLS CUI [7]
C0030193
already participating in a regular, vigorous exercise program (3x/week or more of >60% estimated maximum heart rate)
Beskrivning

Regular exercise Frequency | Vigorous exercise intensity Maximum heart rate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0582191
UMLS CUI [1,2]
C0439603
UMLS CUI [2,1]
C3841230
UMLS CUI [2,2]
C0744679
participants will be excluded from the trial if they are taking any medications that interfere with heart rate response to exercise
Beskrivning

Medication Interferes with Heart rate response Exercise

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1997754
UMLS CUI [1,4]
C0015259
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Similar models

Eligibility Parkinson's Disease NCT02230267

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease
Item
neurologist-diagnosed idiopathic pd based on the uk pd brain bank criteria
boolean
C0030567 (UMLS CUI [1])
Age
Item
aged 45-85
boolean
C0001779 (UMLS CUI [1])
Parkinson Disease Mild Hoehn and Yahr Stage | Parkinson Disease Moderate Hoehn and Yahr Stage
Item
hoehn and yahr stages 1-3 (mild to moderate pd)
boolean
C0030567 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C3639483 (UMLS CUI [1,3])
C0030567 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C3639483 (UMLS CUI [2,3])
Change of medication Absent | Change Operative Surgical Procedures Absent
Item
participants do not anticipate a change in medication or surgical procedures in the next 8 months of the trial (2 months for the trial and 6 for the follow-up)
boolean
C0580105 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0392747 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Study Subject Participation Status Approved
Item
clearance from primary care physician to participate in the trial
boolean
C2348568 (UMLS CUI [1,1])
C0205540 (UMLS CUI [1,2])
Antiparkinson Agents Stable | Deep Brain Stimulation Stable
Item
must be stable on pd medication and dbs for 3 months prior to trial
boolean
C0003405 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0394162 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Cardiovascular Disease Poorly controlled | Cardiovascular Disease Unstable | Exercise participation Excluded
Item
poorly controlled or unstable cardiovascular disease that precludes participation in exercise
boolean
C0007222 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0015259 (UMLS CUI [3,1])
C0679823 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
Moderate dementia Montreal cognitive assessment | Severe dementia Montreal cognitive assessment
Item
moderate-to-severe dementia using the montreal cognitive assessment (moca). we will exclude participants with a moca cut off score of <26/30. this cut off value has excellent sensitivity (90%) and specificity (75%).
boolean
C3494871 (UMLS CUI [1,1])
C3496286 (UMLS CUI [1,2])
C3494652 (UMLS CUI [2,1])
C3496286 (UMLS CUI [2,2])
Lacking Able to stand Duration | Lacking Able to walk Duration
Item
inability to stand or walk for more than 10 minutes
boolean
C0332268 (UMLS CUI [1,1])
C0560884 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C2712089 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Disease Limiting Exercise | Osteoarthritis | Cerebrovascular accident | Respiratory problem | Traumatic Brain Injury | Neuromuscular Diseases | Pain
Item
other significant disorders that would limit endurance exercise participation (i.e., osteoarthritis, stroke, respiratory problems, traumatic brain injury, neuromuscular disease, pain)
boolean
C0012634 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0015259 (UMLS CUI [1,3])
C0029408 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C1659989 (UMLS CUI [4])
C0876926 (UMLS CUI [5])
C0027868 (UMLS CUI [6])
C0030193 (UMLS CUI [7])
Regular exercise Frequency | Vigorous exercise intensity Maximum heart rate
Item
already participating in a regular, vigorous exercise program (3x/week or more of >60% estimated maximum heart rate)
boolean
C0582191 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C3841230 (UMLS CUI [2,1])
C0744679 (UMLS CUI [2,2])
Medication Interferes with Heart rate response Exercise
Item
participants will be excluded from the trial if they are taking any medications that interfere with heart rate response to exercise
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1997754 (UMLS CUI [1,3])
C0015259 (UMLS CUI [1,4])
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