ID

40723

Description

Tai Chi and Physical Therapy for Knee Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01258985

Link

https://clinicaltrials.gov/show/NCT01258985

Keywords

Versions (1)
  1. 5/4/20 5/4/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 4, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Knee Osteoarthritis NCT01258985

English

Eligibility Knee Osteoarthritis NCT01258985

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 40 years and older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
american college of rheumatology criteria for symptomatic knee oa: pain on more than half the days of the past month during at least one of the following activities: walking, going up or down stairs, standing upright, or lying in bed at night;101 radiographic evidence of grade i-iii tibiofemoral or patellofemoral oa: defined as the presence of osteophytes in the tibiofemoral compartment and /or the patellofemoral compartment, as assessed on standing anterior/posterior and lateral views101
Description

Knee Osteoarthritis Symptomatic | Pain During Activity | Walking | Walking Upstairs | Walking Downstairs | Standing Upright | Lying in bed Night time | Osteoarthritis femorotibial Grade Radiography | Patellofemoral osteoarthritis Grade Radiography | Osteophytes Compartment femorotibial | Osteophytes Compartment patellofemoral | X-rays of both knees, AP and lateral views, standing

Data type

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C0026606
UMLS CUI [3]
C0080331
UMLS CUI [4,1]
C0080331
UMLS CUI [4,2]
C0557661
UMLS CUI [5,1]
C0080331
UMLS CUI [5,2]
C0557662
UMLS CUI [6]
C4055530
UMLS CUI [7,1]
C0277816
UMLS CUI [7,2]
C0240526
UMLS CUI [8,1]
C0029408
UMLS CUI [8,2]
C0447795
UMLS CUI [8,3]
C0441800
UMLS CUI [8,4]
C0034571
UMLS CUI [9,1]
C1542808
UMLS CUI [9,2]
C0441800
UMLS CUI [9,3]
C0034571
UMLS CUI [10,1]
C1956089
UMLS CUI [10,2]
C0447798
UMLS CUI [10,3]
C0447795
UMLS CUI [11,1]
C1956089
UMLS CUI [11,2]
C0447798
UMLS CUI [11,3]
C0447801
UMLS CUI [12]
C2322441
womac pain subscale score >= 40 (visual analog version) on at least 1 of 5 questions (range 0 to 100 each)
Description

WOMAC Pain scale

Data type

boolean

Alias
UMLS CUI [1,1]
C3472647
UMLS CUI [1,2]
C1504479
clinical examination confirming knee pain or discomfort or instability referable to the knee joint
Description

Knee pain Confirmed by Clinical examination | Knee discomfort Confirmed by Clinical examination | Knee instability Confirmed by Clinical examination

Data type

boolean

Alias
UMLS CUI [1,1]
C0231749
UMLS CUI [1,2]
C0521093
UMLS CUI [1,3]
C1456356
UMLS CUI [2,1]
C0745538
UMLS CUI [2,2]
C0521093
UMLS CUI [2,3]
C1456356
UMLS CUI [3,1]
C0427262
UMLS CUI [3,2]
C0521093
UMLS CUI [3,3]
C1456356
physically able to participate in both the tai chi and standard pt programs
Description

Participation Tai Ji | Participation Physical therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0376403
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C0949766
willing to undergo testing and intervention procedures and 1.willing to abstain from tai chi until completion of the program, if randomized to standard pt regimen. 2. willing to abstain from standard pt regimen until completion of the program, if randomized to tai chi
Description

Testing | Interventional procedure | Randomization Physical therapy | Randomization Tai Ji

Data type

boolean

Alias
UMLS CUI [1]
C0039593
UMLS CUI [2]
C0184661
UMLS CUI [3,1]
C0034656
UMLS CUI [3,2]
C0949766
UMLS CUI [4,1]
C0034656
UMLS CUI [4,2]
C0376403
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior experience with physical therapy, tai chi or other similar types of complementary and alternative medicine in the past 1 year such as qi gong and yoga since these share some of the principles of tai chi.
Description

Experience Previous Physical therapy | Experience Previous Tai Ji | Experience Previous Qigong | Experience Previous Yoga

Data type

boolean

Alias
UMLS CUI [1,1]
C0596545
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0949766
UMLS CUI [2,1]
C0596545
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0376403
UMLS CUI [3,1]
C0596545
UMLS CUI [3,2]
C0205156
UMLS CUI [3,3]
C0282077
UMLS CUI [4,1]
C0596545
UMLS CUI [4,2]
C0205156
UMLS CUI [4,3]
C2979879
serious medical conditions limiting the ability and safety to participate in either the tai chi or standard pt regimen programs as determined by primary care physicians; these include dementia, neurological disease, symptomatic heart or vascular disease (angina, peripheral vascular disease, congestive heart failure), severe hypertension, recent stroke, severe insulin-dependent diabetes mellitus, psychiatric disease, renal disease, liver disease, active cancer and anemia
Description

Medical condition Serious | Tai Ji Participation Limited | Physical therapy Participation Limited | Dementia | Nervous system disorder | Heart Disease Symptomatic | Vascular Disease Symptomatic | Angina Pectoris | Peripheral Vascular Diseases | Congestive heart failure | Hypertension, severe | Cerebrovascular accident Recent | Insulin-Dependent Diabetes Mellitus Severe | Mental disorders | Kidney Disease | Liver disease | Malignant Neoplasms | Anemia

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0376403
UMLS CUI [2,2]
C0679823
UMLS CUI [2,3]
C0439801
UMLS CUI [3,1]
C0949766
UMLS CUI [3,2]
C0679823
UMLS CUI [3,3]
C0439801
UMLS CUI [4]
C0497327
UMLS CUI [5]
C0027765
UMLS CUI [6,1]
C0018799
UMLS CUI [6,2]
C0231220
UMLS CUI [7,1]
C0042373
UMLS CUI [7,2]
C0231220
UMLS CUI [8]
C0002962
UMLS CUI [9]
C0085096
UMLS CUI [10]
C0018802
UMLS CUI [11]
C4013784
UMLS CUI [12,1]
C0038454
UMLS CUI [12,2]
C0332185
UMLS CUI [13,1]
C0011854
UMLS CUI [13,2]
C0205082
UMLS CUI [14]
C0004936
UMLS CUI [15]
C0022658
UMLS CUI [16]
C0023895
UMLS CUI [17]
C0006826
UMLS CUI [18]
C0002871
any intra-articular steroid injections in the previous 3 months or reconstructive surgery on the affected knee
Description

Steroid Intra-Articular Injections | Reconstructive Surgical Procedure Knee Affected

Data type

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C0021488
UMLS CUI [2,1]
C0524865
UMLS CUI [2,2]
C0022742
UMLS CUI [2,3]
C0392760
any intra-articular synvisc or hyalgan injections in the previous 6 months
Description

Synvisc Intra-Articular Injections | Hyalgan Intra-Articular Injections

Data type

boolean

Alias
UMLS CUI [1,1]
C3239840
UMLS CUI [1,2]
C0021488
UMLS CUI [2,1]
C0598621
UMLS CUI [2,2]
C0021488
inability to pass the mini-mental status examination (with a score below 24)102
Description

Mini-mental state examination Pass Unable | Mini-mental status exam score

Data type

boolean

Alias
UMLS CUI [1,1]
C0451306
UMLS CUI [1,2]
C2828386
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C2225229
inability to walk without a cane or other assistive device 100% of the time during the baseline assessments
Description

Lacking Able to walk Without Cane | Lacking Able to walk Without Assistive Device

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712089
UMLS CUI [1,3]
C0332288
UMLS CUI [1,4]
C0006856
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C2712089
UMLS CUI [2,3]
C0332288
UMLS CUI [2,4]
C0036605
enrollment in any other clinical trial within the last 30 days
Description

Study Subject Participation Status | Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
plan to permanently relocate from the region during the trial period
Description

Relocation of home Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C2699029
UMLS CUI [1,2]
C1301732
positive pregnancy test or planning pregnancy within the study period
Description

Pregnancy test positive | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0240802
UMLS CUI [2]
C0032992
not english-speaking
Description

Lacking Able to speak English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564215
UMLS CUI [1,3]
C0376245
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Similar models

Eligibility Knee Osteoarthritis NCT01258985

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 40 years and older
boolean
C0001779 (UMLS CUI [1])
Knee Osteoarthritis Symptomatic | Pain During Activity | Walking | Walking Upstairs | Walking Downstairs | Standing Upright | Lying in bed Night time | Osteoarthritis femorotibial Grade Radiography | Patellofemoral osteoarthritis Grade Radiography | Osteophytes Compartment femorotibial | Osteophytes Compartment patellofemoral | X-rays of both knees, AP and lateral views, standing
Item
american college of rheumatology criteria for symptomatic knee oa: pain on more than half the days of the past month during at least one of the following activities: walking, going up or down stairs, standing upright, or lying in bed at night;101 radiographic evidence of grade i-iii tibiofemoral or patellofemoral oa: defined as the presence of osteophytes in the tibiofemoral compartment and /or the patellofemoral compartment, as assessed on standing anterior/posterior and lateral views101
boolean
C0409959 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0026606 (UMLS CUI [2,3])
C0080331 (UMLS CUI [3])
C0080331 (UMLS CUI [4,1])
C0557661 (UMLS CUI [4,2])
C0080331 (UMLS CUI [5,1])
C0557662 (UMLS CUI [5,2])
C4055530 (UMLS CUI [6])
C0277816 (UMLS CUI [7,1])
C0240526 (UMLS CUI [7,2])
C0029408 (UMLS CUI [8,1])
C0447795 (UMLS CUI [8,2])
C0441800 (UMLS CUI [8,3])
C0034571 (UMLS CUI [8,4])
C1542808 (UMLS CUI [9,1])
C0441800 (UMLS CUI [9,2])
C0034571 (UMLS CUI [9,3])
C1956089 (UMLS CUI [10,1])
C0447798 (UMLS CUI [10,2])
C0447795 (UMLS CUI [10,3])
C1956089 (UMLS CUI [11,1])
C0447798 (UMLS CUI [11,2])
C0447801 (UMLS CUI [11,3])
C2322441 (UMLS CUI [12])
WOMAC Pain scale
Item
womac pain subscale score >= 40 (visual analog version) on at least 1 of 5 questions (range 0 to 100 each)
boolean
C3472647 (UMLS CUI [1,1])
C1504479 (UMLS CUI [1,2])
Knee pain Confirmed by Clinical examination | Knee discomfort Confirmed by Clinical examination | Knee instability Confirmed by Clinical examination
Item
clinical examination confirming knee pain or discomfort or instability referable to the knee joint
boolean
C0231749 (UMLS CUI [1,1])
C0521093 (UMLS CUI [1,2])
C1456356 (UMLS CUI [1,3])
C0745538 (UMLS CUI [2,1])
C0521093 (UMLS CUI [2,2])
C1456356 (UMLS CUI [2,3])
C0427262 (UMLS CUI [3,1])
C0521093 (UMLS CUI [3,2])
C1456356 (UMLS CUI [3,3])
Participation Tai Ji | Participation Physical therapy
Item
physically able to participate in both the tai chi and standard pt programs
boolean
C0679823 (UMLS CUI [1,1])
C0376403 (UMLS CUI [1,2])
C0679823 (UMLS CUI [2,1])
C0949766 (UMLS CUI [2,2])
Testing | Interventional procedure | Randomization Physical therapy | Randomization Tai Ji
Item
willing to undergo testing and intervention procedures and 1.willing to abstain from tai chi until completion of the program, if randomized to standard pt regimen. 2. willing to abstain from standard pt regimen until completion of the program, if randomized to tai chi
boolean
C0039593 (UMLS CUI [1])
C0184661 (UMLS CUI [2])
C0034656 (UMLS CUI [3,1])
C0949766 (UMLS CUI [3,2])
C0034656 (UMLS CUI [4,1])
C0376403 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Experience Previous Physical therapy | Experience Previous Tai Ji | Experience Previous Qigong | Experience Previous Yoga
Item
prior experience with physical therapy, tai chi or other similar types of complementary and alternative medicine in the past 1 year such as qi gong and yoga since these share some of the principles of tai chi.
boolean
C0596545 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0949766 (UMLS CUI [1,3])
C0596545 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0376403 (UMLS CUI [2,3])
C0596545 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0282077 (UMLS CUI [3,3])
C0596545 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C2979879 (UMLS CUI [4,3])
Medical condition Serious | Tai Ji Participation Limited | Physical therapy Participation Limited | Dementia | Nervous system disorder | Heart Disease Symptomatic | Vascular Disease Symptomatic | Angina Pectoris | Peripheral Vascular Diseases | Congestive heart failure | Hypertension, severe | Cerebrovascular accident Recent | Insulin-Dependent Diabetes Mellitus Severe | Mental disorders | Kidney Disease | Liver disease | Malignant Neoplasms | Anemia
Item
serious medical conditions limiting the ability and safety to participate in either the tai chi or standard pt regimen programs as determined by primary care physicians; these include dementia, neurological disease, symptomatic heart or vascular disease (angina, peripheral vascular disease, congestive heart failure), severe hypertension, recent stroke, severe insulin-dependent diabetes mellitus, psychiatric disease, renal disease, liver disease, active cancer and anemia
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0376403 (UMLS CUI [2,1])
C0679823 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0949766 (UMLS CUI [3,1])
C0679823 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C0497327 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C0018799 (UMLS CUI [6,1])
C0231220 (UMLS CUI [6,2])
C0042373 (UMLS CUI [7,1])
C0231220 (UMLS CUI [7,2])
C0002962 (UMLS CUI [8])
C0085096 (UMLS CUI [9])
C0018802 (UMLS CUI [10])
C4013784 (UMLS CUI [11])
C0038454 (UMLS CUI [12,1])
C0332185 (UMLS CUI [12,2])
C0011854 (UMLS CUI [13,1])
C0205082 (UMLS CUI [13,2])
C0004936 (UMLS CUI [14])
C0022658 (UMLS CUI [15])
C0023895 (UMLS CUI [16])
C0006826 (UMLS CUI [17])
C0002871 (UMLS CUI [18])
Steroid Intra-Articular Injections | Reconstructive Surgical Procedure Knee Affected
Item
any intra-articular steroid injections in the previous 3 months or reconstructive surgery on the affected knee
boolean
C0038317 (UMLS CUI [1,1])
C0021488 (UMLS CUI [1,2])
C0524865 (UMLS CUI [2,1])
C0022742 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
Synvisc Intra-Articular Injections | Hyalgan Intra-Articular Injections
Item
any intra-articular synvisc or hyalgan injections in the previous 6 months
boolean
C3239840 (UMLS CUI [1,1])
C0021488 (UMLS CUI [1,2])
C0598621 (UMLS CUI [2,1])
C0021488 (UMLS CUI [2,2])
Mini-mental state examination Pass Unable | Mini-mental status exam score
Item
inability to pass the mini-mental status examination (with a score below 24)102
boolean
C0451306 (UMLS CUI [1,1])
C2828386 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C2225229 (UMLS CUI [2])
Lacking Able to walk Without Cane | Lacking Able to walk Without Assistive Device
Item
inability to walk without a cane or other assistive device 100% of the time during the baseline assessments
boolean
C0332268 (UMLS CUI [1,1])
C2712089 (UMLS CUI [1,2])
C0332288 (UMLS CUI [1,3])
C0006856 (UMLS CUI [1,4])
C0332268 (UMLS CUI [2,1])
C2712089 (UMLS CUI [2,2])
C0332288 (UMLS CUI [2,3])
C0036605 (UMLS CUI [2,4])
Study Subject Participation Status | Clinical Trial
Item
enrollment in any other clinical trial within the last 30 days
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Relocation of home Planned
Item
plan to permanently relocate from the region during the trial period
boolean
C2699029 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Pregnancy test positive | Pregnancy, Planned
Item
positive pregnancy test or planning pregnancy within the study period
boolean
C0240802 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Lacking Able to speak English Language
Item
not english-speaking
boolean
C0332268 (UMLS CUI [1,1])
C0564215 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
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