SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03045991

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

The Effects and Mechanism of the Sequential Combination of Exercise and Cognitive Training on Cognitive Function in Stroke Patients With Cognitive Decline: A Randomized Controlled Trial

The purpose of this study is to determine the treatment effects of sequential combination of aerobic exercise and cognitive training on cognitive function, physiological markers, daily function, physical function, social participation and quality of life in stroke patients with cognitive decline.

NCT03045991 Stroke Patients With Cognitive Decline
MeSH: Stroke Cognitive Dysfunction
HPO: Cognitive impairment Mental deterioration Stroke

3 Interventions

Name: aerobic exercise training

Description: The aerobic exercise program using progressive resistive stationary bicycle training which will contain warm-up, resistive physical exercise, and cool-down. The training resistance will increase with improvement of participants' performance.

Type: Behavioral

sequential training group (SEQ)

Name: control training

Description: The control training program will receive 30 minutes non-aerobic exercise training, including stretching muscle skills, joint mobility exercises; in addition to one 30-minute session of unstructured mental activities, such as reading books or reading educational films.

Type: Behavioral

control intervention group (CI)

Name: cognitive training

Description: The computerized cognitive training program will be implemented with the brainHQ to target abilities of visuospatial processing, attention, memory, and executive function. The level of the training program will become more difficult with progress in participants' targeted cognitive abilities.

Type: Behavioral

sequential training group (SEQ)


Primary Outcomes

Description: The MoCA will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30

Measure: Change scores of Montreal Cognitive Assessment (MoCA)

Time: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Description: The WMS-III is a standardized and reliable neuropsychological examination tool designed to evaluate visuospatial and memory functions

Measure: Change scores of Wechsler Memory Scale - Third Edition (WMS-III)

Time: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Description: The WAIS-III is developed to measure an individual's intelligence level. It includes tests that evaluate cognitive functions in verbal comprehension, working memory, perceptual organization, and processing speed

Measure: Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)

Time: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Description: The UFOV assessment is a computer-based visual test containing three subtests: visuomotor processing speed, divided attention, and selective attention.

Measure: Change scores of Useful Field of View (UFOV)

Time: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Description: The Stroop Color-Word assesses the abilities of selective attention, inhibition and executive function. The participants will be tested under congruent and incongruent conditions.

Measure: Change scores of Stroop Color-Word test

Time: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Description: The dual-task test evaluates the ability to shift attention between one task and another. Participants will perform the box and block test (BBT) while doing secondary cognitive tasks while sitting. Participants will perform BBT by affected and less affected hand.

Measure: Change scores of Dual-task test

Time: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Secondary Outcomes

Description: Up-regulation of neurotrophic and vascular growth factors

Measure: Change scores of serum BDNF level

Time: Baseline, posttest (an expected average of 3 months)

Description: Antioxidative markers will be used to reflect the changes on oxidative stress. In particular, we will be analyzing the total antioxidant capacity (TAC).

Measure: Change scores of Antioxidative marker

Time: Baseline, posttest (an expected average of 3 months)

Description: HbA1C level will be tested to investigate the relationships between blood glucose level and aerobic exercise

Measure: Change scores of Glucose indicator

Time: Baseline, posttest (an expected average of 3 months)

Description: The cholesterol ratio (total cholesterol divided by high-density lipid) will be evaluated to reflect the lipid level in the blood.

Measure: Change scores of Plasma lipid level

Time: Baseline, posttest (an expected average of 3 months)

Description: The FIM assesses the dependence level of individuals with stroke to perform 18 activities (13 motor and five cognitive tasks) in daily living. The score ranges from 18 to 126 and higher scores demonstrate greater independent participation in daily activities.

Measure: Change scores of Functional Independence Measure (FIM)

Time: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Description: The Lawton IADL scale assesses independent living skills, such as shopping or managing finances.

Measure: Change scores of Lawton Instrumental Activities of Daily Living Scale (Lawton IADL)

Time: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Description: The SIS 3.0 will be used to evaluate health-related quality of life for patients with stroke. The SIS assesses eight domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation/role function) with 59 test items.

Measure: Change scores of Stroke Impact Scale (SIS)

Time: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Description: CB scale evaluates the burden of the primary caregiver of the participants. Lessening the burden of caregivers after the intervention may significantly improve the quality of life for patients with stroke and their family.

Measure: Change scores of Caregiver Burden (CB) scale

Time: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Description: The quality of life will be assessed by the EQ-5D questionnaire which comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

Measure: Change scores of EuroQol (EQ)-5D questionnaire

Time: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Description: The TUG assesses the dynamic balance ability and mobility. The participants will be required to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down.

Measure: Change scores of Timed up and go test (TUG)

Time: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Description: The 6MWT measures the maximum distance walked over 6 minutes, which assess the endurance and mobility level of the participants. The participants could rest as needed during the course of the test.

Measure: Change scores of Six-minute walk test (6MWT)

Time: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Description: Accelerometers will be used to provide an objective measure of the amount of arm movements in real-life situations. The participants will be asked to wear an Actigraphy activity monitor.

Measure: Change scores of Mobility level

Time: Baseline, posttest (an expected average of 3 months)

Description: The IPAQ is an international measure of health-related physical activity.

Measure: Change scores of International Physical Activity Questionnaires (IPAQ)

Time: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Description: The UE-FMA subscale will be used to assess the sensorimotor impairment level of UE in patients after stroke. The UE-FMA contains 33 movements with a score range from 0 to 66. A higher UE-FMA score indicates less impairment of the paretic limb. The validity and reliability of FMA is good to excellent.

Measure: Change scores of Fugl-Meyer Assessment (FMA)

Time: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Description: The RMI evaluates the participant's bed mobility, postural transfers and walking ability. It contains a 15-item scale which includes 14 questions and one direct observation, with a total of score of 15.

Measure: Change scores of Rivermead Mobility Index (RMI)

Time: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Description: Accelerometers will be used to provide an objective measure of the amount of arm movements in real-life situations. The participants will be asked to wear an Actigraphy activity monitor. We will evaluate isometric knee flexors and extensors muscle strength using handheld dynamometer. Also, we will use hand dynamometer to measure grip strength of the affected and less affected hand while the participant is seated, with the elbow at 90-degree flexion. We will record the mean value of 3 attempts.

Measure: Change scores of muscle strength

Time: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Description: The CIQ measures items relevant to home integration, social integration, and productive activities.

Measure: Change scores of Community Integration Questionnaire (CIQ)

Time: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Description: The Chinese version of short form GDS will be used.

Measure: Change scores of Geriatric Depression Scale (GDS)

Time: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Description: Up-regulation of neurotrophic and vascular growth factors

Measure: Genotyping of the BDNF val66met polymorphism

Time: Once during the intervention(an expected average of 3 months)

Description: In addition to MAL, the ActiGraph GX3 accelerometers (ActiGraph, Shalimar, FL, USA) will be used to quantitatively assess the amount of arm use in the participants' home settings.The actigraphy will be placed on bilateral wrist for 3 consecutive days before and after the 1-month intervention. The participants will carry the actigraphy all day except for activities that involve water, such as swimming or bathing. Using the actigraphy, investigators will be able to record and calculate the number of hand movements per minute, and the data will be analyzed with the MAHUFFE software (http://www.mrc-epid.cam.ac.uk/). The actigraphy has often been used to evaluate arm use in patients with stroke.

Measure: Change scores of Actigraphy

Time: Baseline, posttest (an expected average of 3 months)

Description: The Mini-Mental State Examination (MMSE) is the most commonly administered psychometric screening assessment of cognitive functioning. The MMSE is used to screen patients for cognitive impairment, track changes in cognitive functioning over time, and often to assess the effects of therapeutic agents on cognitive function. The total score of MMSE ranged from 0 to 30. Higher values represent a better cognitive functioning.

Measure: Change scores of Mini-Mental State Exam (MMSE)

Time: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Description: The MRC is an ordinal scale that assesses muscle strength. The scoring for each muscle ranges from 0 to 5, with a higher score indicates stronger muscle. The reliability of MRC for all muscle groups was good to excellent in patients with stroke.

Measure: Change scores of Medical Research Council scale (MRC)

Time: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Description: The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.

Measure: Change scores of National Institutes of Health Stroke Scale

Time: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 V66M

The Chinese version of short form GDS will be used.. Genotyping of the BDNF val66met polymorphism. --- val66met ---



HPO Nodes


HPO:
Cognitive impairment
Genes 527
NHLRC1 HEXA HEXB MAG UBA5 CLN8 GDF5 SDHAF1 EPRS TREX1 AARS ERCC2 PNKP ERCC3 ERCC4 ERCC5 ERCC6 CRLF1 ERF MAOA STUB1 HLA-B PDGFB CENPE PDGFRB MAPT HLA-DQB1 SMC1A HLA-DRB1 TRAIP GDF6 ACTB KATNB1 LRRK2 SLC5A7 PEX1 PEX6 PEX10 PEX12 PEX13 DHDDS PEX14 LAGE3 RPS20 TSC1 TSC2 CHD2 TIMMDC1 HNF4A HNRNPA1 TTPA CHRM3 ABCA7 REEP2 MECP2 TTR HNRNPA2B1 TUBA4A KLRC4 MEFV MYORG PGM3 ADD3 TBC1D24 CHRNG SPG21 TNFSF4 MEN1 MEOX1 TTC8 ERCC8 TYROBP HEPACAM TUBB4A UBA1 ADRA2B FBN1 PANK2 SERPINI1 ATRIP MBTPS2 AARS2 ATXN1 ATXN2 FKTN PIK3CA ATXN7 UBTF CLN3 DSTYK CLN5 SCN1A RIN2 SCN2A UCP2 SCN3A CCDC78 CLTC SCN8A ATXN3 FBXO7 PEX16 DCAF17 MLH1 FGD1 KMT2A CYP7B1 RNF216 PLA2G6 CCR1 AKT1 FGF12 FGF14 TOMM40 FGFR3 ATXN10 ABCD1 UQCRC2 TP53RK MTO1 SLC30A9 HSD17B4 POMK ITM2B GMPPB SEC61A1 LTBP4 PLP1 ADAMTSL4 KCNT1 ALG12 ALOX12B SEC23B MOG SDHA SDHB SDHC VCP SDHD COL1A1 COL3A1 ATG5 POMT2 PMS1 KCTD7 COL5A1 COL5A2 FLNA PMS2 VPS37A UBQLN2 FMR1 ARV1 SLC25A4 PLEKHG4 CISD2 CTC1 FKRP WFS1 FA2H RRM2B POLG MPDU1 B3GALNT2 PEX3 LZTFL1 NDUFAF3 DOLK BBIP1 IKBKG POMGNT1 PORCN CP TWNK OPA3 NPC2 SPG11 CNKSR2 LIPN XPA MSH2 XPC POMT1 APOE SIM1 OSGEP XRCC4 APP IDUA FAS GDF3 GBA2 SLC1A2 ZNF365 YWHAG SLC2A1 SLC2A3 ALG2 MMACHC PEX26 CYFIP2 NECAP1 CHMP2B TRAK1 FAN1 MTFMT PRKRA SDR9C7 SLC6A1 UGT1A1 TMEM106B PPP2R2B MLH3 ARSA PPP3CA SNCAIP CSF1R ATP6 TRNC COX1 COX2 COX3 PPT1 CYTB ASAH1 MTOR SLC18A2 SLC20A2 TTC37 TBK1 NUS1 C12ORF65 ND1 VPS35 ND4 ND5 ND6 CST3 CNTNAP2 NUP133 CSTB RNR1 PRKAR1A PRKAR1B GIGYF2 DNAJC5 CYP4F22 SLC13A5 TRNE TRNF PRKCG FTL CEP152 MFSD8 TRNH TRNK TRNL1 ATM CTNS FUS COASY CERS1 TRNP TRNQ SNCB ATP1A2 ATP1A3 TRNS1 SNCA TRNS2 C9ORF72 RNASEH1 TRNV TRNW MAPK10 CTSD CTSH CTSK BBS12 DNAJC3 PLK4 PRNP TMEM240 PINK1 SORL1 GABRB2 GABRB3 IL10 MYD88 IL12A ATP6V1A IFT140 IBA57 ATP6V1E1 CTSF CHCHD10 GALC HTRA1 NKX6-2 SPAST CENPJ ATP7B PSAP KMT2B WWOX PSEN1 SPG7 PSEN2 ATR WDR4 AUH ERAP1 SPR ABCA12 DISC2 VPS13C GJB6 MATR3 SDCCAG8 APTX SPTBN2 CYP27A1 INSR NAGA NAGLU CPLX1 GBA SPART GBE1 NBN PTPN22 GCDH IRF6 GCH1 NDP NDUFA6 PDE10A PEX11B SRCAP ITGA7 PTEN METTL23 DNAJC6 DCTN1 ADA2 NDUFB8 DDB2 GDNF NDUFS2 BDNF NAGS TTC19 STAT4 SNORD118 ITPR1 SYNGAP1 TIMM8A BMPR1A GJB2 PRDM8 CCM2 ARL6IP6 KCNA2 CEP120 PNPLA6 STXBP1 GLA GLB1 BRAF KCNB1 KCNC1 SYNJ1 SULT2B1 TINF2 NFIA KCND3 PTS SQSTM1 SGPL1 ABCC8 SURF1 AP5Z1 DGUOK C19ORF12 SUMF1 KCNJ11 EIF2B4 EIF2B3 AFG3L2 VAMP1 EIF2B2 EIF2B5 VPS13A PEX19 PEX2 PEX5 CLN6 MFN2 GM2A ALDH18A1 KCNQ2 KCNQ3 C4A CACNA1G KIF5A GNAS SEMA4A RAB39B DMD CAMTA1 ROBO3 DNM1 PHOX2B QDPR RAB27A IL23R NOTCH3 DNMT1 PDE11A TBP NPC1 NPHP1 CACNA1A KRAS MARS2 SCO2 KRT6A KRT6B NIPAL4 HNF1A SOST CUX2 DNAJC13 EPM2A ROGDI KRT16 AMN NRAS ATN1 KRT17 NUP107 GNE SZT2 PRICKLE1 RBBP8 KRT81 KRT83 HCN1 MYO1H NTRK2 KRT86 TPRKB HGSNAT NR4A2 LAMA2 DNM1L GJC2 GRID2 GRN LAMP2 OCRL BBS5 GRIN2D RBM28 PRRT2 CUBN SLC7A7 TYMP ECM1 ATP13A2 MCOLN1 OPA1 EDN3 DARS2 TSFM KRIT1 BBS10 EEF1A2 RMRP TGFBR2 TARDBP TGM1 MSH6 COL18A1 WDR45 KLLN LMNB1 ABCA5 SMC3 P2RY11 AIFM1 IL12A-AS1 TK2 AASS EIF2B1 ALG9 SCARB2 SLC25A15 AP3B2 TLR4 PRDX1 EIF4G1 PAH CTDP1 TREM2 CYP2U1 UBAC2 WDR73 ZFYVE26 ALOXE3 CLMP DSG4 BSCL2 HSD17B10 POLG2 PDCD10 EPCAM CLCF1 HCRT TP53 HTT ATP6V0A2 JPH3 PCNT XPR1 ALG13 LARGE1
Mental deterioration
Genes 266
NHLRC1 GABRB2 HEXA GABRB3 HEXB UBA5 CLN8 SDHAF1 ATP6V1A TREX1 AARS ATP6V1E1 CTSF CHCHD10 ERCC2 GALC HTRA1 ERCC4 ERCC6 SPAST ATP7B PSAP WWOX PSEN1 PSEN2 PDGFB PDGFRB MAPT DISC2 VPS13C SMC1A MATR3 APTX CYP27A1 ACTB NAGLU LRRK2 CPLX1 GBA GBE1 DHDDS NBN IRF6 CHD2 GCH1 NDP NDUFA6 PDE10A TIMMDC1 HNF4A DCTN1 ADA2 HNRNPA1 NDUFB8 TTPA ABCA7 MECP2 TTR HNRNPA2B1 TUBA4A NDUFS2 MYORG SNORD118 TBC1D24 SPG21 SYNGAP1 ERCC8 TYROBP HEPACAM TIMM8A TUBB4A PRDM8 PANK2 KCNA2 SERPINI1 PNPLA6 STXBP1 MBTPS2 GLB1 AARS2 KCNB1 KCNC1 SYNJ1 TINF2 ATXN2 ATXN7 PTS SQSTM1 SGPL1 UBTF CLN3 ABCC8 SURF1 CLN5 AP5Z1 SCN1A DGUOK C19ORF12 SUMF1 KCNJ11 UCP2 SCN3A CLTC SCN8A VPS13A ATXN3 FBXO7 DCAF17 CLN6 MFN2 GM2A ALDH18A1 KMT2A RNF216 PLA2G6 FGF12 TOMM40 ATXN10 ABCD1 GNAS RAB39B DNM1 QDPR ITM2B PLP1 RAB27A SDHA NOTCH3 SDHB VCP SDHD DNMT1 PDE11A TBP NPC1 KCTD7 CACNA1A SCO2 HNF1A CUX2 DNAJC13 EPM2A ROGDI UBQLN2 FMR1 AMN NRAS ATN1 ARV1 PLEKHG4 SZT2 CISD2 PRICKLE1 CTC1 WFS1 HCN1 FA2H NTRK2 RRM2B POLG NDUFAF3 HGSNAT NR4A2 DNM1L CP TWNK GRN NPC2 SPG11 CNKSR2 XPA GRIN2D RBM28 APOE CUBN APP IDUA TYMP GBA2 ATP13A2 MCOLN1 SLC1A2 YWHAG OPA1 SLC2A3 MMACHC CYFIP2 NECAP1 CHMP2B TRAK1 EEF1A2 SLC6A1 TMEM106B TARDBP COL18A1 WDR45 PPP2R2B ARSA PPP3CA SNCAIP CSF1R ATP6 TRNC COX1 LMNB1 COX2 COX3 PPT1 CYTB ASAH1 TK2 SLC20A2 SCARB2 TBK1 NUS1 ND1 AP3B2 VPS35 ND5 PRDX1 EIF4G1 ND6 PAH CST3 CNTNAP2 TREM2 CSTB PRKAR1A PRKAR1B GIGYF2 DNAJC5 SLC13A5 TRNE TRNF PRKCG ZFYVE26 FTL BSCL2 MFSD8 HSD17B10 TRNK TRNL1 CTNS FUS COASY CERS1 TRNQ SNCB ATP1A2 ATP1A3 TRNS1 SNCA TRNS2 C9ORF72 RNASEH1 TRNV TRNW MAPK10 CTSD PRNP HTT ATP6V0A2 PINK1 JPH3 XPR1 SORL1
Stroke
Genes 117
MPL COL3A1 COL4A1 VHL TET2 TPP2 MYD88 COL5A1 FLNA TREX1 NPPA MYH11 HTRA1 ZMPSTE24 MYLK SH2B3 CLIP2 WFS1 CALR CYP11B1 MAT2A ACAD9 SMARCAL1 ACTA2 ACTB SLC19A2 GATA4 GATA6 ACTG1 BAZ1B DPM3 NR3C1 CPS1 ACVRL1 RFC2 APP GTF2IRD1 GDF2 ADA2 CBS MECP2 TTR ZAP70 ABCC6 NR2F2 NAGS SNAP29 STIM1 TGFB2 TGFB3 JAK2 TGFBR1 SLC2A10 TGFBR2 TGFBR3 CRELD1 MFAP5 MLXIPL ANGPTL6 LIMK1 OTC CCM2 FBN1 GTF2I THPO GLA PIGA TRNC LMNA COX1 COX2 COX3 GUCY1A1 PIK3C2A CYTB MTHFR LOX GYS1 JAG1 ND1 ND4 SCN5A ND5 AGXT ASS1 DYRK1B ND6 CST3 KCNQ1 TRNF TRNH ELN TRNK TRNL1 GNAQ PRKG1 RFT1 TRNQ PRKAG2 TRNS1 TRNS2 TRNV TRNW HBB ENG TNXB TBL2 MMUT PRNP TP53 NOTCH3 SMAD3 SMAD4 SON PCNT FOXE3 PMM2