ID

31272

Beskrivning

Exercise Intervention to Reduce Postural Instability in Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00708734

Länk

https://clinicaltrials.gov/show/NCT00708734

Nyckelord

Versioner (1)
  1. 2018-08-06 2018-08-06 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

6 augusti 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00708734

Engelsk

Eligibility Osteoarthritis NCT00708734

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 50 and older.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
corrected vision not worse than 20/50.
Beskrivning

Corrected visual acuity

Datatyp

boolean

Alias
UMLS CUI [1]
C1275680
ability to ambulate household distances without an assistive device - minimum functional status for ambulation as primary mode of mobility.
Beskrivning

Able to walk Distance Short | Independent of Walking assistive device | Minimum Functional Status Ambulation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2712089
UMLS CUI [1,2]
C0012751
UMLS CUI [1,3]
C1806781
UMLS CUI [2,1]
C0332291
UMLS CUI [2,2]
C3874140
UMLS CUI [3,1]
C1524031
UMLS CUI [3,2]
C0598463
UMLS CUI [3,3]
C0945826
presence of knee oa based on clinical and radiological criteria.
Beskrivning

Osteoarthritis, Knee

Datatyp

boolean

Alias
UMLS CUI [1]
C0409959
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
cognitive impairment with mini mental state exam (mmse) score <24; scores at or below 24 indicate cognitive impairments, limiting ability to participate in the group and/or remember instructions.
Beskrivning

Impaired cognition Mini-mental state examination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0338656
UMLS CUI [1,2]
C0451306
metastatic cancer, since this limits ability to fully participate in the group and/or complete the intervention due to limited life expectancy and changing functional status.
Beskrivning

Neoplasm Metastasis | Life Expectancy Limited | Functional Status Change

Datatyp

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C0023671
UMLS CUI [2,2]
C0439801
UMLS CUI [3,1]
C0598463
UMLS CUI [3,2]
C0392747
central or peripheral neurological dysfunction e.g. diagnosis of hemiparesis, cerebellar dysfunction, parkinson's disease , peripheral neuropathy with or without foot drop, as determined by medical record review and physical exam; severe peripheral vascular disease with claudication or spinal stenosis with pseudoclaudication/chronic low back pain; these impairments would further impair gait and balance, and would jeopardize safety during the intervention and/or confound the effect of the intervention.
Beskrivning

Neurological Dysfunction Central | Neurological Dysfunction Peripheral Nerves | Hemiparesis | Cerebellar Diseases | Parkinson Disease | Peripheral Neuropathy Associated with Foot-drop | Peripheral Neuropathy Without Foot-drop | Peripheral Vascular Disease Severe | Claudication | Spinal Stenosis | Pseudoclaudication syndrome | Chronic low back pain | Gait Impaired | Balance Impaired | Impairment compromises Safety | Impairment Interferes with Effect Intervention

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1709219
UMLS CUI [1,2]
C0205099
UMLS CUI [2,1]
C1709219
UMLS CUI [2,2]
C0031119
UMLS CUI [3]
C0018989
UMLS CUI [4]
C0007760
UMLS CUI [5]
C0030567
UMLS CUI [6,1]
C0031117
UMLS CUI [6,2]
C0332281
UMLS CUI [6,3]
C0085684
UMLS CUI [7,1]
C0031117
UMLS CUI [7,2]
C0332288
UMLS CUI [7,3]
C0085684
UMLS CUI [8,1]
C0085096
UMLS CUI [8,2]
C0205082
UMLS CUI [9]
C1456822
UMLS CUI [10]
C0037944
UMLS CUI [11]
C0152121
UMLS CUI [12]
C0457949
UMLS CUI [13,1]
C0016928
UMLS CUI [13,2]
C0221099
UMLS CUI [14,1]
C0014653
UMLS CUI [14,2]
C0221099
UMLS CUI [15,1]
C0221099
UMLS CUI [15,2]
C2945640
UMLS CUI [15,3]
C0036043
UMLS CUI [16,1]
C0221099
UMLS CUI [16,2]
C0521102
UMLS CUI [16,3]
C1280500
UMLS CUI [16,4]
C0184661
lower extremity amputations, or foot deformities; mobility limitations due to altered lower extremity skin integrity/ulcer, where weight-bearing would be contraindicated (foot ulcers), since this would affect gait and balance measures.
Beskrivning

Amputation of lower limb | Foot Deformities | Mobility Limitation | Etiology Change Integrity of skin Lower Extremity | Etiology Leg Ulcer | Contraindication Weight Bearing | Foot Ulcer

Datatyp

boolean

Alias
UMLS CUI [1]
C0337308
UMLS CUI [2]
C0016506
UMLS CUI [3]
C1565249
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0392747
UMLS CUI [4,3]
C1286235
UMLS CUI [4,4]
C0023216
UMLS CUI [5,1]
C0015127
UMLS CUI [5,2]
C0023223
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0085086
UMLS CUI [7]
C0085119
use of medications known to impair balance, e.g. antipsychotics, benzodiazepines, anti-epileptics, etc. which would affect gait and balance measures.
Beskrivning

Pharmaceutical Preparations Impairing Balance | Antipsychotic Agents | Benzodiazepines | Antiepileptic Agents

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C0014653
UMLS CUI [2]
C0040615
UMLS CUI [3]
C0005064
UMLS CUI [4]
C0003299
severe arthritis limiting basic activities of daily living (adl) and were offered or are pending joint replacement, since it is unlikely that any non-pharmacological intervention would be effective.
Beskrivning

Arthritis Severe Limiting Activities of Daily Living | Joint Replacement Offered | Joint Replacement Pending

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0439801
UMLS CUI [1,4]
C0001288
UMLS CUI [2,1]
C0185317
UMLS CUI [2,2]
C1444648
UMLS CUI [3,1]
C0185317
UMLS CUI [3,2]
C1611271
total knee replacement on one or both sides, since gait and balance changes due to total knee replacement would confound the effect of interventions.
Beskrivning

Knee Replacement Side Quantity | Gait Change Due to Knee Replacement | Balamce Change Due to Knee Replacement | Interference Effect Intervention

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0086511
UMLS CUI [1,2]
C0441987
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0016928
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0086511
UMLS CUI [3,1]
C0014653
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C0086511
UMLS CUI [4,1]
C0521102
UMLS CUI [4,2]
C1280500
UMLS CUI [4,3]
C0184661
current involvement in physical therapy, since it would confound results.
Beskrivning

Physical therapy Interferes with Research results

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0949766
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
medically unstable upon exam, i.e. poorly controlled blood pressure or blood sugar, unstable coronary artery disease, since group participation may compromise medical status.
Beskrivning

Status Medical Unstable | Blood Pressure Poorly controlled | Blood Glucose Poorly controlled | Coronary Artery Disease Unstable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C0205476
UMLS CUI [1,3]
C0443343
UMLS CUI [2,1]
C0005823
UMLS CUI [2,2]
C3853134
UMLS CUI [3,1]
C0005802
UMLS CUI [3,2]
C3853134
UMLS CUI [4,1]
C1956346
UMLS CUI [4,2]
C0443343
morbid obesity (bmi>40) due to potential changes in gait variables (speed, cadence, stride length).
Beskrivning

Obesity, Morbid | Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C0028756
UMLS CUI [2]
C1305855
weight over 300 pounds (due to limitations of neurocom force plate).
Beskrivning

Body Weight Pounds Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0439219
UMLS CUI [1,3]
C1265611
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Similar models

Eligibility Osteoarthritis NCT00708734

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 50 and older.
boolean
C0001779 (UMLS CUI [1])
Corrected visual acuity
Item
corrected vision not worse than 20/50.
boolean
C1275680 (UMLS CUI [1])
Able to walk Distance Short | Independent of Walking assistive device | Minimum Functional Status Ambulation
Item
ability to ambulate household distances without an assistive device - minimum functional status for ambulation as primary mode of mobility.
boolean
C2712089 (UMLS CUI [1,1])
C0012751 (UMLS CUI [1,2])
C1806781 (UMLS CUI [1,3])
C0332291 (UMLS CUI [2,1])
C3874140 (UMLS CUI [2,2])
C1524031 (UMLS CUI [3,1])
C0598463 (UMLS CUI [3,2])
C0945826 (UMLS CUI [3,3])
Osteoarthritis, Knee
Item
presence of knee oa based on clinical and radiological criteria.
boolean
C0409959 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Impaired cognition Mini-mental state examination
Item
cognitive impairment with mini mental state exam (mmse) score <24; scores at or below 24 indicate cognitive impairments, limiting ability to participate in the group and/or remember instructions.
boolean
C0338656 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
Neoplasm Metastasis | Life Expectancy Limited | Functional Status Change
Item
metastatic cancer, since this limits ability to fully participate in the group and/or complete the intervention due to limited life expectancy and changing functional status.
boolean
C0027627 (UMLS CUI [1])
C0023671 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0598463 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
Neurological Dysfunction Central | Neurological Dysfunction Peripheral Nerves | Hemiparesis | Cerebellar Diseases | Parkinson Disease | Peripheral Neuropathy Associated with Foot-drop | Peripheral Neuropathy Without Foot-drop | Peripheral Vascular Disease Severe | Claudication | Spinal Stenosis | Pseudoclaudication syndrome | Chronic low back pain | Gait Impaired | Balance Impaired | Impairment compromises Safety | Impairment Interferes with Effect Intervention
Item
central or peripheral neurological dysfunction e.g. diagnosis of hemiparesis, cerebellar dysfunction, parkinson's disease , peripheral neuropathy with or without foot drop, as determined by medical record review and physical exam; severe peripheral vascular disease with claudication or spinal stenosis with pseudoclaudication/chronic low back pain; these impairments would further impair gait and balance, and would jeopardize safety during the intervention and/or confound the effect of the intervention.
boolean
C1709219 (UMLS CUI [1,1])
C0205099 (UMLS CUI [1,2])
C1709219 (UMLS CUI [2,1])
C0031119 (UMLS CUI [2,2])
C0018989 (UMLS CUI [3])
C0007760 (UMLS CUI [4])
C0030567 (UMLS CUI [5])
C0031117 (UMLS CUI [6,1])
C0332281 (UMLS CUI [6,2])
C0085684 (UMLS CUI [6,3])
C0031117 (UMLS CUI [7,1])
C0332288 (UMLS CUI [7,2])
C0085684 (UMLS CUI [7,3])
C0085096 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C1456822 (UMLS CUI [9])
C0037944 (UMLS CUI [10])
C0152121 (UMLS CUI [11])
C0457949 (UMLS CUI [12])
C0016928 (UMLS CUI [13,1])
C0221099 (UMLS CUI [13,2])
C0014653 (UMLS CUI [14,1])
C0221099 (UMLS CUI [14,2])
C0221099 (UMLS CUI [15,1])
C2945640 (UMLS CUI [15,2])
C0036043 (UMLS CUI [15,3])
C0221099 (UMLS CUI [16,1])
C0521102 (UMLS CUI [16,2])
C1280500 (UMLS CUI [16,3])
C0184661 (UMLS CUI [16,4])
Amputation of lower limb | Foot Deformities | Mobility Limitation | Etiology Change Integrity of skin Lower Extremity | Etiology Leg Ulcer | Contraindication Weight Bearing | Foot Ulcer
Item
lower extremity amputations, or foot deformities; mobility limitations due to altered lower extremity skin integrity/ulcer, where weight-bearing would be contraindicated (foot ulcers), since this would affect gait and balance measures.
boolean
C0337308 (UMLS CUI [1])
C0016506 (UMLS CUI [2])
C1565249 (UMLS CUI [3])
C0015127 (UMLS CUI [4,1])
C0392747 (UMLS CUI [4,2])
C1286235 (UMLS CUI [4,3])
C0023216 (UMLS CUI [4,4])
C0015127 (UMLS CUI [5,1])
C0023223 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C0085086 (UMLS CUI [6,2])
C0085119 (UMLS CUI [7])
Pharmaceutical Preparations Impairing Balance | Antipsychotic Agents | Benzodiazepines | Antiepileptic Agents
Item
use of medications known to impair balance, e.g. antipsychotics, benzodiazepines, anti-epileptics, etc. which would affect gait and balance measures.
boolean
C0013227 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0014653 (UMLS CUI [1,3])
C0040615 (UMLS CUI [2])
C0005064 (UMLS CUI [3])
C0003299 (UMLS CUI [4])
Arthritis Severe Limiting Activities of Daily Living | Joint Replacement Offered | Joint Replacement Pending
Item
severe arthritis limiting basic activities of daily living (adl) and were offered or are pending joint replacement, since it is unlikely that any non-pharmacological intervention would be effective.
boolean
C0003864 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0001288 (UMLS CUI [1,4])
C0185317 (UMLS CUI [2,1])
C1444648 (UMLS CUI [2,2])
C0185317 (UMLS CUI [3,1])
C1611271 (UMLS CUI [3,2])
Knee Replacement Side Quantity | Gait Change Due to Knee Replacement | Balamce Change Due to Knee Replacement | Interference Effect Intervention
Item
total knee replacement on one or both sides, since gait and balance changes due to total knee replacement would confound the effect of interventions.
boolean
C0086511 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0016928 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0086511 (UMLS CUI [2,4])
C0014653 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C0086511 (UMLS CUI [3,4])
C0521102 (UMLS CUI [4,1])
C1280500 (UMLS CUI [4,2])
C0184661 (UMLS CUI [4,3])
Physical therapy Interferes with Research results
Item
current involvement in physical therapy, since it would confound results.
boolean
C0949766 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
Status Medical Unstable | Blood Pressure Poorly controlled | Blood Glucose Poorly controlled | Coronary Artery Disease Unstable
Item
medically unstable upon exam, i.e. poorly controlled blood pressure or blood sugar, unstable coronary artery disease, since group participation may compromise medical status.
boolean
C0449438 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
C0005823 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
C0005802 (UMLS CUI [3,1])
C3853134 (UMLS CUI [3,2])
C1956346 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
Obesity, Morbid | Body mass index
Item
morbid obesity (bmi>40) due to potential changes in gait variables (speed, cadence, stride length).
boolean
C0028756 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Body Weight Pounds Quantity
Item
weight over 300 pounds (due to limitations of neurocom force plate).
boolean
C0005910 (UMLS CUI [1,1])
C0439219 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
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