Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-02-28 @ 2:51 AM
Study NCT ID:
NCT03616535
Status:
TERMINATED
Last Update Posted:
2025-07-16
First Post:
2018-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Interventions Made to Preserve Cognitive Function
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000091942', 'term': 'Cognitive Training'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mara.mcadamsdemarco@nyulangone.org', 'phone': '1-646-987-1358', 'title': 'Dr. Mara McAdams DeMarco', 'organization': 'NYU Grossman School of Medicine and Langone Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 18 months after enrollment for mortality; up to 12 months after enrollment for hospitalizations; all else up to 6 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Cognitive Training', 'description': 'Participants randomized to CT will play "brain games" on a tablet. They will be asked to engage in the activity for a minimum of 30 minutes during each hemodialysis session. At each HD session, participants will have 10 different brain games to play and the games will vary for each session.\n\nCognitive training: The investigators will provide participants with tablets to play brain games.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 24, 'seriousNumAtRisk': 31, 'deathsNumAffected': 6, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Exercise Training', 'description': 'Participants randomized to the ET arm will be given a stationary foot peddler and will be asked to engage in the activity for a minimum of 30 minutes at each hemodialysis session. ET will start with a 2 minute warm up, then the resistance will be adjusted so that participants are working at perceived exertion of "somewhat strong," using the Borg scale (87) (\\~50 rpm). Resistance will be increased when the rating falls below "somewhat hard."\n\nExercise training: The investigators will provide participants with foot peddlers.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 21, 'seriousNumAtRisk': 29, 'deathsNumAffected': 4, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Combined Cognitive and Exercise Training', 'description': 'Participants in the CT+ET arm will start with 30 minutes of CT (playing "brain games" on tablet) with a 15-minute break, and then, 30 minutes of ET (stationary foot peddler).\n\nCombined cognitive and exercise training: The investigators will provide participants with tablets to play brain games for cognitive training and stationary foot peddlers for exercise training.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 28, 'seriousNumAtRisk': 35, 'deathsNumAffected': 3, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Standard of Care', 'description': 'Participants in this arm will receive standard of care', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 12, 'seriousNumAtRisk': 26, 'deathsNumAffected': 4, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cramp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated heart rate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'other unexpected event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization/Prolonged Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Executive Function as Assessed by the Trail Making Test Assessment (TMT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training', 'description': 'Participants randomized to CT will play "brain games" on a tablet. They will be asked to engage in the activity for a minimum of 30 minutes during each hemodialysis session. At each HD session, participants will have 10 different brain games to play and the games will vary for each session.\n\nCognitive training: The investigators will provide participants with tablets to play brain games.'}, {'id': 'OG001', 'title': 'Exercise Training', 'description': 'Participants randomized to the ET arm will be given a stationary foot peddler and will be asked to engage in the activity for a minimum of 30 minutes at each hemodialysis session . ET will start with a 2 minute warm up, then the resistance will be adjusted so that participants are working at perceived exertion of "somewhat strong," using the Borg scale (87) (\\~50 rpm). Resistance will be increased when the rating falls below "somewhat hard."\n\nExercise training: The investigators will provide participants with foot peddlers.'}, {'id': 'OG002', 'title': 'Combined Cognitive and Exercise Training', 'description': 'Participants in the CT+ET arm will start with 30 minutes of CT (playing "brain games" on tablet) with a 15-minute break, and then, 30 minutes of ET (stationary foot peddler).\n\nCombined cognitive and exercise training: The investigators will provide participants with tablets to play brain games for cognitive training and stationary foot peddlers for exercise training.'}, {'id': 'OG003', 'title': 'Standard of Care', 'description': 'Participants in this arm will receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '20.4', 'spread': '54.9', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '82', 'groupId': 'OG001'}, {'value': '-5.6', 'spread': '101.7', 'groupId': 'OG002'}, {'value': '5.7', 'spread': '53.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Change in executive function between baseline and 3 months as assessed by the Trail Making Test which is comprised of Part A and Part B. Executive function is assessed by the time (seconds) to complete Part B minus the time (seconds) to complete Part A. Needing more time to complete the test indicates worse executive function.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to COVID-19 shutdowns, the trial was terminated early by the DSMB. All participants with available TMT A/B at baseline and 3 months of follow-up were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change in Global Cognitive Function as Measured by the Montreal Cognitive Assessment (MoCA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training', 'description': 'Participants randomized to CT will play "brain games" on a tablet. They will be asked to engage in the activity for a minimum of 30 minutes during each hemodialysis session. At each HD session, participants will have 10 different brain games to play and the games will vary for each session.\n\nCognitive training: The investigators will provide participants with tablets to play brain games.'}, {'id': 'OG001', 'title': 'Exercise Training', 'description': 'Participants randomized to the ET arm will be given a stationary foot peddler and will be asked to engage in the activity for a minimum of 30 minutes at each hemodialysis session . ET will start with a 2 minute warm up, then the resistance will be adjusted so that participants are working at perceived exertion of "somewhat strong," using the Borg scale (87) (\\~50 rpm). Resistance will be increased when the rating falls below "somewhat hard."\n\nExercise training: The investigators will provide participants with foot peddlers.'}, {'id': 'OG002', 'title': 'Combined Cognitive and Exercise Training', 'description': 'Participants in the CT+ET arm will start with 30 minutes of CT (playing "brain games" on tablet) with a 15-minute break, and then, 30 minutes of ET (stationary foot peddler).\n\nCombined cognitive and exercise training: The investigators will provide participants with tablets to play brain games for cognitive training and stationary foot peddlers for exercise training.'}, {'id': 'OG003', 'title': 'Standard of Care', 'description': 'Participants in this arm will receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '3.1', 'groupId': 'OG002'}, {'value': '-0.6', 'spread': '3.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months', 'description': 'Change in global cognitive function at 3-months of interventions as measured by the Montreal Cognitive Assessment (MoCA). It is a brief 30 question test that assesses different cognitive domains: attention and concentration, executive functions, memory, language, visual construction skills, conceptual thinking, calculations, and orientation. Total possible score range is 0-30 points, and a score of 26 or above is considered normal.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an available MoCA at baseline and 3-month follow-up were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Completing Executive Function as Measured by the Stroop Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training', 'description': 'Participants randomized to CT will play "brain games" on a tablet. They will be asked to engage in the activity for a minimum of 30 minutes during each hemodialysis session. At each HD session, participants will have 10 different brain games to play and the games will vary for each session.\n\nCognitive training: The investigators will provide participants with tablets to play brain games.'}, {'id': 'OG001', 'title': 'Exercise Training', 'description': 'Participants randomized to the ET arm will be given a stationary foot peddler and will be asked to engage in the activity for a minimum of 30 minutes at each hemodialysis session . ET will start with a 2 minute warm up, then the resistance will be adjusted so that participants are working at perceived exertion of "somewhat strong," using the Borg scale (87) (\\~50 rpm). Resistance will be increased when the rating falls below "somewhat hard."\n\nExercise training: The investigators will provide participants with foot peddlers.'}, {'id': 'OG002', 'title': 'Combined Cognitive and Exercise Training', 'description': 'Participants in the CT+ET arm will start with 30 minutes of CT (playing "brain games" on tablet) with a 15-minute break, and then, 30 minutes of ET (stationary foot peddler).\n\nCombined cognitive and exercise training: The investigators will provide participants with tablets to play brain games for cognitive training and stationary foot peddlers for exercise training.'}, {'id': 'OG003', 'title': 'Standard of Care', 'description': 'Participants in this arm will receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': "Number completing the Stroop test of executive function at 3 months of interventions. The Stroop test asks participants to view two conflicting pieces of information, specifically the word itself and the color of the ink it's printed in. Participants are asked to name the color of the ink used to print words, rather than reading the words themselves.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an available Stroop test at 3-month follow-up were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Executive Function as Measured by the Digit Symbol Substitution Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training', 'description': 'Participants randomized to CT will play "brain games" on a tablet. They will be asked to engage in the activity for a minimum of 30 minutes during each hemodialysis session. At each HD session, participants will have 10 different brain games to play and the games will vary for each session.\n\nCognitive training: The investigators will provide participants with tablets to play brain games.'}, {'id': 'OG001', 'title': 'Exercise Training', 'description': 'Participants randomized to the ET arm will be given a stationary foot peddler and will be asked to engage in the activity for a minimum of 30 minutes at each hemodialysis session . ET will start with a 2 minute warm up, then the resistance will be adjusted so that participants are working at perceived exertion of "somewhat strong," using the Borg scale (87) (\\~50 rpm). Resistance will be increased when the rating falls below "somewhat hard."\n\nExercise training: The investigators will provide participants with foot peddlers.'}, {'id': 'OG002', 'title': 'Combined Cognitive and Exercise Training', 'description': 'Participants in the CT+ET arm will start with 30 minutes of CT (playing "brain games" on tablet) with a 15-minute break, and then, 30 minutes of ET (stationary foot peddler).\n\nCombined cognitive and exercise training: The investigators will provide participants with tablets to play brain games for cognitive training and stationary foot peddlers for exercise training.'}, {'id': 'OG003', 'title': 'Standard of Care', 'description': 'Participants in this arm will receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '15.6', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '18.9', 'groupId': 'OG002'}, {'value': '.7', 'spread': '20', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 3 months', 'description': 'Change in executive function at 3 months of interventions as measure by the Digit Symbol Substitution Test. This test evaluates the speed and working memory components of executive function. It involves a key consisting of the numbers 1-9, each paired with a unique, easy-to--draw symbol such as a "V", "+" or "\\>". Below the key are a series of the numbers 1-9 in random order and repeated several times. The participant is allowed 90 seconds to fill in the corresponding symbol for each number. This task requires the individual to visually scan the answer key provided at the top of the test and then write the correct symbol by each number as quickly as possible. The correct number of symbols written within 90 seconds is measured. Total possible score ranges from a minimum of 0 to a maximum of 90 points. Higher scores represent better outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an available Digit Symbol Substitution Test at baseline and 3-month follow-up were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Physical Function as Measured by the Short Physical Performance Battery (SPPB) Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training', 'description': 'Participants randomized to CT will play "brain games" on a tablet. They will be asked to engage in the activity for a minimum of 30 minutes during each hemodialysis session. At each HD session, participants will have 10 different brain games to play and the games will vary for each session.\n\nCognitive training: The investigators will provide participants with tablets to play brain games.'}, {'id': 'OG001', 'title': 'Exercise Training', 'description': 'Participants randomized to the ET arm will be given a stationary foot peddler and will be asked to engage in the activity for a minimum of 30 minutes at each hemodialysis session . ET will start with a 2 minute warm up, then the resistance will be adjusted so that participants are working at perceived exertion of "somewhat strong," using the Borg scale (87) (\\~50 rpm). Resistance will be increased when the rating falls below "somewhat hard."\n\nExercise training: The investigators will provide participants with foot peddlers.'}, {'id': 'OG002', 'title': 'Combined Cognitive and Exercise Training', 'description': 'Participants in the CT+ET arm will start with 30 minutes of CT (playing "brain games" on tablet) with a 15-minute break, and then, 30 minutes of ET (stationary foot peddler).\n\nCombined cognitive and exercise training: The investigators will provide participants with tablets to play brain games for cognitive training and stationary foot peddlers for exercise training.'}, {'id': 'OG003', 'title': 'Standard of Care', 'description': 'Participants in this arm will receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '3.8', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '2.8', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '1.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in lower extremity function at 3 months of interventions using the SPPB test. The SPPB is an objective assessment tool for evaluating lower extremity functioning This test is a performance-based assessment comprised of 3 tasks: 1) repeated chair stands, 2) standing balance, and 3) a 4-meter usual paced walk in those with and without a walking aid (meters/second). Participants receive a score of 0 for a task if they were unable to complete the task; otherwise, they receive scores of 1-4 based on population-based norms. The scores of the three tasks are summed to create the SPPB score. The SPPB score ranges from 0 to 12, with lower scores indicating poorer function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an available SPPB at baseline and 3-month follow-up were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Injurious Fall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training', 'description': 'Participants randomized to CT will play "brain games" on a tablet. They will be asked to engage in the activity for a minimum of 30 minutes during each hemodialysis session. At each HD session, participants will have 10 different brain games to play and the games will vary for each session.\n\nCognitive training: The investigators will provide participants with tablets to play brain games.'}, {'id': 'OG001', 'title': 'Exercise Training', 'description': 'Participants randomized to the ET arm will be given a stationary foot peddler and will be asked to engage in the activity for a minimum of 30 minutes at each hemodialysis session . ET will start with a 2 minute warm up, then the resistance will be adjusted so that participants are working at perceived exertion of "somewhat strong," using the Borg scale (87) (\\~50 rpm). Resistance will be increased when the rating falls below "somewhat hard."\n\nExercise training: The investigators will provide participants with foot peddlers.'}, {'id': 'OG002', 'title': 'Combined Cognitive and Exercise Training', 'description': 'Participants in the CT+ET arm will start with 30 minutes of CT (playing "brain games" on tablet) with a 15-minute break, and then, 30 minutes of ET (stationary foot peddler).\n\nCombined cognitive and exercise training: The investigators will provide participants with tablets to play brain games for cognitive training and stationary foot peddlers for exercise training.'}, {'id': 'OG003', 'title': 'Standard of Care', 'description': 'Participants in this arm will receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Number of participants with an injurious falls resulting in a medical encounter during the 6 months of interventions and for 6 months after the interventions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training', 'description': 'Participants randomized to CT will play "brain games" on a tablet. They will be asked to engage in the activity for a minimum of 30 minutes during each hemodialysis session. At each HD session, participants will have 10 different brain games to play and the games will vary for each session.\n\nCognitive training: The investigators will provide participants with tablets to play brain games.'}, {'id': 'OG001', 'title': 'Exercise Training', 'description': 'Participants randomized to the ET arm will be given a stationary foot peddler and will be asked to engage in the activity for a minimum of 30 minutes at each hemodialysis session . ET will start with a 2 minute warm up, then the resistance will be adjusted so that participants are working at perceived exertion of "somewhat strong," using the Borg scale (87) (\\~50 rpm). Resistance will be increased when the rating falls below "somewhat hard."\n\nExercise training: The investigators will provide participants with foot peddlers.'}, {'id': 'OG002', 'title': 'Combined Cognitive and Exercise Training', 'description': 'Participants in the CT+ET arm will start with 30 minutes of CT (playing "brain games" on tablet) with a 15-minute break, and then, 30 minutes of ET (stationary foot peddler).\n\nCombined cognitive and exercise training: The investigators will provide participants with tablets to play brain games for cognitive training and stationary foot peddlers for exercise training.'}, {'id': 'OG003', 'title': 'Standard of Care', 'description': 'Participants in this arm will receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'The number of participants with a hospitalizations during the 6 months of interventions and 6 months after the interventions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training', 'description': 'Participants randomized to CT will play "brain games" on a tablet. They will be asked to engage in the activity for a minimum of 30 minutes during each hemodialysis session. At each HD session, participants will have 10 different brain games to play and the games will vary for each session.\n\nCognitive training: The investigators will provide participants with tablets to play brain games.'}, {'id': 'OG001', 'title': 'Exercise Training', 'description': 'Participants randomized to the ET arm will be given a stationary foot peddler and will be asked to engage in the activity for a minimum of 30 minutes at each hemodialysis session . ET will start with a 2 minute warm up, then the resistance will be adjusted so that participants are working at perceived exertion of "somewhat strong," using the Borg scale (87) (\\~50 rpm). Resistance will be increased when the rating falls below "somewhat hard."\n\nExercise training: The investigators will provide participants with foot peddlers.'}, {'id': 'OG002', 'title': 'Combined Cognitive and Exercise Training', 'description': 'Participants in the CT+ET arm will start with 30 minutes of CT (playing "brain games" on tablet) with a 15-minute break, and then, 30 minutes of ET (stationary foot peddler).\n\nCombined cognitive and exercise training: The investigators will provide participants with tablets to play brain games for cognitive training and stationary foot peddlers for exercise training.'}, {'id': 'OG003', 'title': 'Standard of Care', 'description': 'Participants in this arm will receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '18 months', 'description': 'Mortality will be ascertained within the 6 months of the intervention and 1 year after the intervention (1.5 years total).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Patient-centered Outcomes as Measured by the Kidney Disease Quality of Life (KDQOL) Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training', 'description': 'Participants randomized to CT will play "brain games" on a tablet. They will be asked to engage in the activity for a minimum of 30 minutes during each hemodialysis session. At each HD session, participants will have 10 different brain games to play and the games will vary for each session.\n\nCognitive training: The investigators will provide participants with tablets to play brain games.'}, {'id': 'OG001', 'title': 'Exercise Training', 'description': 'Participants randomized to the ET arm will be given a stationary foot peddler and will be asked to engage in the activity for a minimum of 30 minutes at each hemodialysis session . ET will start with a 2 minute warm up, then the resistance will be adjusted so that participants are working at perceived exertion of "somewhat strong," using the Borg scale (87) (\\~50 rpm). Resistance will be increased when the rating falls below "somewhat hard."\n\nExercise training: The investigators will provide participants with foot peddlers.'}, {'id': 'OG002', 'title': 'Combined Cognitive and Exercise Training', 'description': 'Participants in the CT+ET arm will start with 30 minutes of CT (playing "brain games" on tablet) with a 15-minute break, and then, 30 minutes of ET (stationary foot peddler).\n\nCombined cognitive and exercise training: The investigators will provide participants with tablets to play brain games for cognitive training and stationary foot peddlers for exercise training.'}, {'id': 'OG003', 'title': 'Standard of Care', 'description': 'Participants in this arm will receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '1.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in kidney disease-specific physical and mental quality of life at 3 months. Using a single the question from the KDQOL: In general, would you say your health is \\_\\_\\_ ? It is reported on a 5-point score: 1, poor; 2, fair; 3, good; 4, very good; 5, excellent. Higher is better. While the score of KDQOL ranges from 1 to 5 points, we are measuring the 3-month change in this score. Therefore, the change could range from -4 to 4 points.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available KDQOL at baseline and 3-month follow-up were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Patient-centered Outcomes as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training', 'description': 'Participants randomized to CT will play "brain games" on a tablet. They will be asked to engage in the activity for a minimum of 30 minutes during each hemodialysis session. At each HD session, participants will have 10 different brain games to play and the games will vary for each session.\n\nCognitive training: The investigators will provide participants with tablets to play brain games.'}, {'id': 'OG001', 'title': 'Exercise Training', 'description': 'Participants randomized to the ET arm will be given a stationary foot peddler and will be asked to engage in the activity for a minimum of 30 minutes at each hemodialysis session . ET will start with a 2 minute warm up, then the resistance will be adjusted so that participants are working at perceived exertion of "somewhat strong," using the Borg scale (87) (\\~50 rpm). Resistance will be increased when the rating falls below "somewhat hard."\n\nExercise training: The investigators will provide participants with foot peddlers.'}, {'id': 'OG002', 'title': 'Combined Cognitive and Exercise Training', 'description': 'Participants in the CT+ET arm will start with 30 minutes of CT (playing "brain games" on tablet) with a 15-minute break, and then, 30 minutes of ET (stationary foot peddler).\n\nCombined cognitive and exercise training: The investigators will provide participants with tablets to play brain games for cognitive training and stationary foot peddlers for exercise training.'}, {'id': 'OG003', 'title': 'Standard of Care', 'description': 'Participants in this arm will receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '22.2', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '13.5', 'groupId': 'OG001'}, {'value': '-3.9', 'spread': '19.8', 'groupId': 'OG002'}, {'value': '-5.6', 'spread': '17.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in Patient-centered Outcomes as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 The change in PROMIS-29 score at 3 months is reported. Scores range from 0-140; higher scores are better.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with available PROMIS-29 at baseline and 3 months were included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Amputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training', 'description': 'Participants randomized to CT will play "brain games" on a tablet. They will be asked to engage in the activity for a minimum of 30 minutes during each hemodialysis session. At each HD session, participants will have 10 different brain games to play and the games will vary for each session.\n\nCognitive training: The investigators will provide participants with tablets to play brain games.'}, {'id': 'OG001', 'title': 'Exercise Training', 'description': 'Participants randomized to the ET arm will be given a stationary foot peddler and will be asked to engage in the activity for a minimum of 30 minutes at each hemodialysis session . ET will start with a 2 minute warm up, then the resistance will be adjusted so that participants are working at perceived exertion of "somewhat strong," using the Borg scale (87) (\\~50 rpm). Resistance will be increased when the rating falls below "somewhat hard."\n\nExercise training: The investigators will provide participants with foot peddlers.'}, {'id': 'OG002', 'title': 'Combined Cognitive and Exercise Training', 'description': 'Participants in the CT+ET arm will start with 30 minutes of CT (playing "brain games" on tablet) with a 15-minute break, and then, 30 minutes of ET (stationary foot peddler).\n\nCombined cognitive and exercise training: The investigators will provide participants with tablets to play brain games for cognitive training and stationary foot peddlers for exercise training.'}, {'id': 'OG003', 'title': 'Standard of Care', 'description': 'Participants in this arm will receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'The number of participants with an amputation during the 6 months of interventions and 6 months after interventions. This information will be either self-reported by the participant or abstracted from the medical records to see if the interventions are associated with amputations', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Able to Return to Work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training', 'description': 'Participants randomized to CT will play "brain games" on a tablet. They will be asked to engage in the activity for a minimum of 30 minutes during each hemodialysis session. At each HD session, participants will have 10 different brain games to play and the games will vary for each session.\n\nCognitive training: The investigators will provide participants with tablets to play brain games.'}, {'id': 'OG001', 'title': 'Exercise Training', 'description': 'Participants randomized to the ET arm will be given a stationary foot peddler and will be asked to engage in the activity for a minimum of 30 minutes at each hemodialysis session . ET will start with a 2 minute warm up, then the resistance will be adjusted so that participants are working at perceived exertion of "somewhat strong," using the Borg scale (87) (\\~50 rpm). Resistance will be increased when the rating falls below "somewhat hard."\n\nExercise training: The investigators will provide participants with foot peddlers.'}, {'id': 'OG002', 'title': 'Combined Cognitive and Exercise Training', 'description': 'Participants in the CT+ET arm will start with 30 minutes of CT (playing "brain games" on tablet) with a 15-minute break, and then, 30 minutes of ET (stationary foot peddler).\n\nCombined cognitive and exercise training: The investigators will provide participants with tablets to play brain games for cognitive training and stationary foot peddlers for exercise training.'}, {'id': 'OG003', 'title': 'Standard of Care', 'description': 'Participants in this arm will receive standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'The number of participants able to return to work during the 6 months of interventions and 6 months after interventions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Among those who were unemployed or on leave of absence at baseline'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cognitive Training', 'description': 'Participants randomized to CT will play "brain games" on a tablet. They will be asked to engage in the activity for a minimum of 30 minutes during each hemodialysis (HD) session. At each HD session, participants will have 10 different brain games to play and the games will vary for each session.\n\nCognitive training: The investigators will provide participants with tablets to play brain games.'}, {'id': 'FG001', 'title': 'Exercise Training', 'description': 'Participants randomized to the Exercise Training (ET) arm will be given a stationary foot peddler and will be asked to engage in the activity for a minimum of 30 minutes at each hemodialysis session. ET will start with a 2 minute warm up, then the resistance will be adjusted so that participants are working at perceived exertion of "somewhat strong," using the Borg scale (87) (\\~50 rpm). Resistance will be increased when the rating falls below "somewhat hard."\n\nExercise training: The investigators will provide participants with foot peddlers.'}, {'id': 'FG002', 'title': 'Combined Cognitive and Exercise Training', 'description': 'Participants in the CT+ET arm will start with 30 minutes of CT (playing "brain games" on tablet) with a 15-minute break, and then, 30 minutes of ET (stationary foot peddler).\n\nCombined cognitive and exercise training: The investigators will provide participants with tablets to play brain games for cognitive training and stationary foot peddlers for exercise training.'}, {'id': 'FG003', 'title': 'Standard of Care', 'description': 'Participants in this arm will receive standard of care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Not specified or change in eligibility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was stopped after enrolling 130 participants by the Data Safety Monitoring Board (DSMB) due to COVID-19 shutdowns.', 'preAssignmentDetails': '130 participants were consented. There were 9 participants who were consented but not randomized due to COVID-19 shutdowns. They are not included in the results.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '121', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Cognitive Training', 'description': 'Participants randomized to CT will play "brain games" on a tablet. They will be asked to engage in the activity for a minimum of 30 minutes during each hemodialysis session. At each HD session, participants will have 10 different brain games to play and the games will vary for each session.\n\nCognitive training: The investigators will provide participants with tablets to play brain games.'}, {'id': 'BG001', 'title': 'Exercise Training', 'description': 'Participants randomized to the ET arm will be given a stationary foot peddler and will be asked to engage in the activity for a minimum of 30 minutes at each hemodialysis session . ET will start with a 2 minute warm up, then the resistance will be adjusted so that participants are working at perceived exertion of "somewhat strong," using the Borg scale (87) (\\~50 rpm). Resistance will be increased when the rating falls below "somewhat hard."\n\nExercise training: The investigators will provide participants with foot peddlers.'}, {'id': 'BG002', 'title': 'Combined Cognitive and Exercise Training', 'description': 'Participants in the CT+ET arm will start with 30 minutes of CT (playing "brain games" on tablet) with a 15-minute break, and then, 30 minutes of ET (stationary foot peddler).\n\nCombined cognitive and exercise training: The investigators will provide participants with tablets to play brain games for cognitive training and stationary foot peddlers for exercise training.'}, {'id': 'BG003', 'title': 'Standard of Care', 'description': 'Participants in this arm will receive standard of care'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.2', 'groupId': 'BG000', 'lowerLimit': '56.2', 'upperLimit': '69.9'}, {'value': '58.4', 'groupId': 'BG001', 'lowerLimit': '48.9', 'upperLimit': '66.0'}, {'value': '60.4', 'groupId': 'BG002', 'lowerLimit': '52.0', 'upperLimit': '70.3'}, {'value': '60.4', 'groupId': 'BG003', 'lowerLimit': '38.3', 'upperLimit': '66.5'}, {'value': '61.5', 'groupId': 'BG004', 'lowerLimit': '52.0', 'upperLimit': '67.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '76', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White/Caucasian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '89', 'groupId': 'BG004'}]}]}, {'title': 'Asian/Asian American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '121', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-18', 'size': 544440, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-20T11:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'whyStopped': 'DSMB terminated study due to COVID-19 delays in recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-27', 'studyFirstSubmitDate': '2018-06-13', 'resultsFirstSubmitDate': '2025-03-20', 'studyFirstSubmitQcDate': '2018-07-31', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-24', 'studyFirstPostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Executive Function as Assessed by the Trail Making Test Assessment (TMT)', 'timeFrame': '3 months', 'description': 'Change in executive function between baseline and 3 months as assessed by the Trail Making Test which is comprised of Part A and Part B. Executive function is assessed by the time (seconds) to complete Part B minus the time (seconds) to complete Part A. Needing more time to complete the test indicates worse executive function.'}], 'secondaryOutcomes': [{'measure': 'Change in Global Cognitive Function as Measured by the Montreal Cognitive Assessment (MoCA)', 'timeFrame': 'Baseline, 3 months', 'description': 'Change in global cognitive function at 3-months of interventions as measured by the Montreal Cognitive Assessment (MoCA). It is a brief 30 question test that assesses different cognitive domains: attention and concentration, executive functions, memory, language, visual construction skills, conceptual thinking, calculations, and orientation. Total possible score range is 0-30 points, and a score of 26 or above is considered normal.'}, {'measure': 'Number of Participants Completing Executive Function as Measured by the Stroop Test', 'timeFrame': '3 months', 'description': "Number completing the Stroop test of executive function at 3 months of interventions. The Stroop test asks participants to view two conflicting pieces of information, specifically the word itself and the color of the ink it's printed in. Participants are asked to name the color of the ink used to print words, rather than reading the words themselves."}, {'measure': 'Change in Executive Function as Measured by the Digit Symbol Substitution Test', 'timeFrame': 'baseline and 3 months', 'description': 'Change in executive function at 3 months of interventions as measure by the Digit Symbol Substitution Test. This test evaluates the speed and working memory components of executive function. It involves a key consisting of the numbers 1-9, each paired with a unique, easy-to--draw symbol such as a "V", "+" or "\\>". Below the key are a series of the numbers 1-9 in random order and repeated several times. The participant is allowed 90 seconds to fill in the corresponding symbol for each number. This task requires the individual to visually scan the answer key provided at the top of the test and then write the correct symbol by each number as quickly as possible. The correct number of symbols written within 90 seconds is measured. Total possible score ranges from a minimum of 0 to a maximum of 90 points. Higher scores represent better outcomes.'}, {'measure': 'Change in Physical Function as Measured by the Short Physical Performance Battery (SPPB) Test', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in lower extremity function at 3 months of interventions using the SPPB test. The SPPB is an objective assessment tool for evaluating lower extremity functioning This test is a performance-based assessment comprised of 3 tasks: 1) repeated chair stands, 2) standing balance, and 3) a 4-meter usual paced walk in those with and without a walking aid (meters/second). Participants receive a score of 0 for a task if they were unable to complete the task; otherwise, they receive scores of 1-4 based on population-based norms. The scores of the three tasks are summed to create the SPPB score. The SPPB score ranges from 0 to 12, with lower scores indicating poorer function.'}, {'measure': 'Number of Participants With an Injurious Fall', 'timeFrame': '12 months', 'description': 'Number of participants with an injurious falls resulting in a medical encounter during the 6 months of interventions and for 6 months after the interventions'}, {'measure': 'Number of Participants With a Hospitalizations', 'timeFrame': '12 months', 'description': 'The number of participants with a hospitalizations during the 6 months of interventions and 6 months after the interventions'}, {'measure': 'Mortality', 'timeFrame': '18 months', 'description': 'Mortality will be ascertained within the 6 months of the intervention and 1 year after the intervention (1.5 years total).'}, {'measure': 'Change in Patient-centered Outcomes as Measured by the Kidney Disease Quality of Life (KDQOL) Survey', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in kidney disease-specific physical and mental quality of life at 3 months. Using a single the question from the KDQOL: In general, would you say your health is \\_\\_\\_ ? It is reported on a 5-point score: 1, poor; 2, fair; 3, good; 4, very good; 5, excellent. Higher is better. While the score of KDQOL ranges from 1 to 5 points, we are measuring the 3-month change in this score. Therefore, the change could range from -4 to 4 points.'}, {'measure': 'Change in Patient-centered Outcomes as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in Patient-centered Outcomes as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 The change in PROMIS-29 score at 3 months is reported. Scores range from 0-140; higher scores are better.'}, {'measure': 'Number of Participants With an Amputation', 'timeFrame': '12 months', 'description': 'The number of participants with an amputation during the 6 months of interventions and 6 months after interventions. This information will be either self-reported by the participant or abstracted from the medical records to see if the interventions are associated with amputations'}, {'measure': 'Number of Participants Able to Return to Work', 'timeFrame': '12 months', 'description': 'The number of participants able to return to work during the 6 months of interventions and 6 months after interventions.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ESRD']}, 'referencesModule': {'references': [{'pmid': '35018639', 'type': 'DERIVED', 'citation': 'Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.'}, {'pmid': '32883245', 'type': 'DERIVED', 'citation': 'McAdams-DeMarco MA, Chu NM, Steckel M, Kunwar S, Gonzalez Fernandez M, Carlson MC, Fine DM, Appel LJ, Diener-West M, Segev DL. Interventions Made to Preserve Cognitive Function Trial (IMPCT) study protocol: a multi-dialysis center 2x2 factorial randomized controlled trial of intradialytic cognitive and exercise training to preserve cognitive function. BMC Nephrol. 2020 Sep 3;21(1):383. doi: 10.1186/s12882-020-02041-y.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, controlled trial to slow cognitive decline in adults undergoing hemodialysis (HD). The investigators will test three interventions cognitive training (CT), exercise training (ET), and combined cognitive and exercise training (CT+ET) relative to standard of care (SC).', 'detailedDescription': 'This will be a two by two factorial, randomized, controlled trial to slow cognitive decline in adults undergoing hemodialysis (HD). The investigators primary objective is to determine if receiving cognitive training (tablet-based brain games), exercise training (stationary foot pedal), or combined cognitive and exercise training preserves executive function relative to those with standard of care . The secondary objectives are to compare the rates of end stage renal disease (ESRD)-specific clinical outcomes and patient centered outcomes among those receiving CT, or ET, or CT+ET relative to those in SC. The investigators will formally test whether receiving CT or ET will preserve executive function and receiving combined CT+ET will preserve executive function better than CT or ET alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older at enrollment\n* English speaking\n* within 3 months to 3 years of initiating hemodialysis\n* receiving hemodialysis at participating dialysis centers\n\nExclusion Criteria: Patients with the following conditions will be excluded:\n\n* Pregnancy\n* Angina Pectoris\n* Chronic lung disease requiring oxygen\n* Musculoskeletal conditions that limit mobility\n* Upper or lower extremity amputation\n* Orthopedic disorders exacerbated by physical activity\n* Femoral arteriovenous (AV) access\n* Hepatitis B infection\n* Blindness/Legal blindness\n\nIn addition to conditions outlined above, patients who are currently incarcerated will be excluded from the study.'}, 'identificationModule': {'nctId': 'NCT03616535', 'acronym': 'IMPCT', 'briefTitle': 'Interventions Made to Preserve Cognitive Function', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Hemodialysis-based Interventions to Preserve Cognitive Function', 'orgStudyIdInfo': {'id': 'IRB00152858'}, 'secondaryIdInfos': [{'id': 'R01DK114074', 'link': 'https://reporter.nih.gov/quickSearch/R01DK114074', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive training', 'description': 'Participants randomized to CT will play "brain games" on a tablet. They will be asked to engage in the activity for a minimum of 30 minutes during each hemodialysis session for 6 months. At each HD session, participants will have 10 different brain games to play and the games will vary for each session.', 'interventionNames': ['Other: Cognitive training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise training', 'description': 'Participants randomized to the ET arm will be given a stationary foot peddler and will be asked to engage in the activity for a minimum of 30 minutes at each hemodialysis session for 6 months. ET will start with a 2 minute warm up, then the resistance will be adjusted so that participants are working at perceived exertion of "somewhat strong," using the Borg scale (87) (\\~50 rpm). Resistance will be increased when the rating falls below "somewhat hard."', 'interventionNames': ['Other: Exercise training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combined cognitive and exercise training', 'description': 'Participants in the CT+ET arm will start with 30 minutes of CT (playing "brain games" on tablet) with a 15-minute break, and then, 30 minutes of ET (stationary foot peddler).', 'interventionNames': ['Other: Combined cognitive and exercise training']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Participants in this arm will receive standard of care'}], 'interventions': [{'name': 'Cognitive training', 'type': 'OTHER', 'otherNames': ['CT'], 'description': 'The investigators will provide participants with tablets to play brain games.', 'armGroupLabels': ['Cognitive training']}, {'name': 'Exercise training', 'type': 'OTHER', 'otherNames': ['ET'], 'description': 'The investigators will provide participants with foot peddlers.', 'armGroupLabels': ['Exercise training']}, {'name': 'Combined cognitive and exercise training', 'type': 'OTHER', 'otherNames': ['CT+ET'], 'description': 'The investigators will provide participants with tablets to play brain games for cognitive training and stationary foot peddlers for exercise training.', 'armGroupLabels': ['Combined cognitive and exercise training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Aarti Mathur, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}