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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG055391 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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Primary Specific Aim: Determine the effect of the combined physical exercise and cognitive training on the cognitive function of ICU survivors aged 50 and older. Hypothesis: In comparison to older ICU survivors randomized to attention control or either intervention alone, those randomized to 12 weeks of combined physical exercise and cognitive training will have higher total index cognitive scores as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at 3 and 6 months post randomization.
Secondary Specific Aim 1: Determine the effect of the combined physical exercise and cognitive training on physical performance, anxiety and depressive symptoms, and quality of life of ICU survivors aged 50 and older. Hypotheses: In comparison to older ICU survivors randomized to attention control or either intervention alone, those randomized to 12 weeks of combined physical exercise and cognitive training will have higher physical performance as measured by short physical performance battery (SPPB) and two-minute step test, lower mood and anxiety symptoms as measured by Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder (GAD-7) scale, and higher quality of life as measured by the Medical Outcomes Study 36-item short form (SF-36) at 3 and 6-months post randomization.
Exploratory Aim 2: To examine the mechanisms of action of combined training. Hypothesis: At the completion of treatment, the combined intervention group will show reduced serum levels of CRP, IL-1, IL-6, IL-8, TNF-α, S-100β, and GFAP and increased levels of BDNF, VEGF, and IGF-1 compared to the attention control, or either intervention alone groups.
Critical illness has deleterious consequences on both acute and chronic cognitive functions. Acute cognitive dysfunction manifests itself as delirium in the critically ill especially the elderly. Delirium is a complex neuropsychiatric syndrome characterized by acute and fluctuating changes in cognition and consciousness. 60% to 80% of critically ill ventilated older patients and 30% to 50% of those with less illness severity have delirium for at least one day of their ICU or hospital stay. Chronic cognitive dysfunction manifests as ICU acquired cognitive impairment and dementia after critical illness, affects multiple cognitive domains and persists years after hospital discharge. Up to 71% of critical illness survivors have cognitive impairment at one year after hospital discharge and close to 18% are diagnosed with new dementia including Alzheimer's disease within three years post ICU hospitalization.
Two million older Americans suffer from an episode of delirium during their intensive care unit (ICU) stay. Presence of delirium predisposes the elderly to immediate in-hospital complications including a longer length of ICU and hospital stay, increased risk of in-patient mortality and elevated costs of care. In addition, ICU delirium is associated with long-term post-discharge complications such as development of cognitive impairment and dementia. Current advances in the management of critical illness have notably improved the survival rates among this vulnerable segment of older adults. However, increased survival comes at a cost with as many as 70% of older ICU survivors who had an episode of delirium suffering from subsequent cognitive impairment and dementia. At present, there are no effective and scalable recovery models to remediate ICU acquired cognitive impairment and its attendant elevated dementia or Alzheimer's disease risk.
The inability to develop efficacious interventions to reduce ICU acquired cognitive impairment may stem from a limited understanding of the link between acute brain dysfunction (delirium) and chronic brain dysfunction (ICU acquired cognitive impairment, dementia or Alzheimer's disease). The investigators propose a recovery intervention guided by the pathophysiologic mechanisms implicated in producing critical illness delirium and elevated risk of cognitive impairment. The intervention targets inflammation, glial dysfunction and astrocyte activation along with restoration of neurotrophic factors while training function directly across multiple cognitive domains to reduce the burden of cognitive impairment among ICU survivors of delirium.
Over the past five years, Indiana University Center for Aging Research has developed a research infrastructure focused on delirium and delirium associated cognitive impairment, encompassing the ICU and post-ICU periods. This includes developing a bio-repository of serum delirium biomarkers, ICU based delirium trials, and post-ICU exercise and cognitive therapy recovery models. Building upon prior work and based on the pathophysiologic mechanisms mentioned above, the investigators now propose a novel home-based combined physical exercise and cognitive training program for older ICU survivors to improve cognitive impairment.
The study team is proposing a 2x2 factorial design randomized controlled trial (RCT) called "Decreasing Alzheimer's Disease and Related Dementias after Delirium-Exercise and Cognitive Training (DDD-ECT)" to evaluate the efficacy of 12 weeks of combined physical exercise and cognitive training on the primary outcome of cognitive function among older ICU survivors who experienced delirium or subsyndromal delirium during their ICU stay. The investigators propose to deliver these interventions via a facilitator-led, small group format using internet-enabled, multiparty-videoconference delivered directly into the participants' homes to achieve the study aims listed in the summary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Exercise and Cognitive Training | Experimental | Physical Exercise Intervention: The physical exercise portion of the combined intervention consists of 45 minutes of multi-modal physical exercise focused on seated aerobic and progressive resistance training designed to improve aerobic capacity, muscular strength and endurance consistent with current exercise recommendations. The study team will deliver 3 sessions per week for 3 months. Cognitive Intervention: The cognitive portion of the combined intervention consists of a suite of 24 programs called Brain HQ developed by Posit Science Inc., organized into six categories: attention, speed, memory, people skills, intelligence, and navigation. The DDD-ECT trial will use 45-minute sessions of Brain HQ exercises. The modules are designed to improve time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory. |
|
| Physical Exercise and Cognitive Control | Active Comparator | Physical Exercise Intervention: The physical exercise portion of the combined intervention consists of 45 minutes of multi-modal physical exercise focused on seated aerobic and progressive resistance training designed to improve aerobic capacity, muscular strength and endurance consistent with current exercise recommendations. The study team will deliver 3 sessions per week for 3 months. Cognitive Control: This consists of up to 20 minutes of puzzles and games, 2 days per week for 3 months. The participants will use on-line Brain HQ Control Games hosted by Posit Science, Inc. as an attention control. |
|
| Cognitive Training and Stretching Control | Active Comparator | Stretching Control: This consists of up to 10 minutes of gentle stretching. The study team will deliver 3 sessions per week for 3 months. Cognitive Intervention: The cognitive portion of the combined intervention consists of a suite of 24 programs called Brain HQ developed by Posit Science Inc., organized into six categories: attention, speed, memory, people skills, intelligence, and navigation. The DDD-ECT trial will use 45-minute sessions of Brain HQ exercises. The modules are designed to improve time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory. ly directing one session per week and available as needed for rest of the sessions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Exercise Intervention | Behavioral | In home exercise intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Status Outcome at 6 Months | The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) will measure cognitive status. The z-scores for the subscales have a mean of 0 and standard deviation of 1. The overall z-score is the mean of the 7-item z-scores. Z-scores above the standard deviation represent better cognitive outcomes. | 6 months post study randomization |
| Cognitive Status Outcome at 3 Months | The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) will measure cognitive status. The z-scores for the subscales have a mean of 0 and standard deviation of 1. The overall z-score is the mean of the 7-item z-scores. Z-scores above the standard deviation represent better cognitive outcomes. | 3 months post study randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Performance Scores at 3 Months | The Short Physical Performance Battery (SPPB) will measure physical training effects on balance and strength. Ranges from 0-12: higher score is better outcome | 3 month post study randomization |
| Physical Performance Scores at 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health West Hospital | Avon | Indiana | 46123 | United States | ||
| Indiana University Health North Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40402024 | Derived | Khan SH, Perkins AJ, Unverzagt FW, Wang S, Moser LR, Moiz S, Jawaid S, Corlett D, Clark DO, Boustani MA, Gao S, Khan BA. Improving Recovery and Outcomes Every Day After the ICU (IMPROVE): A Randomized Controlled Trial. Crit Care Med. 2025 Aug 1;53(8):e1542-e1553. doi: 10.1097/CCM.0000000000006698. Epub 2025 May 22. | |
| 29580264 | Derived | Wang S, Hammes J, Khan S, Gao S, Harrawood A, Martinez S, Moser L, Perkins A, Unverzagt FW, Clark DO, Boustani M, Khan B. Improving Recovery and Outcomes Every Day after the ICU (IMPROVE): study protocol for a randomized controlled trial. Trials. 2018 Mar 27;19(1):196. doi: 10.1186/s13063-018-2569-8. |
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Per protocol subjects were considered to be enrolled in the study at the time of completion of the informed consent process. 249 subjects were enrolled. 153 subjects were randomized to one of the four study groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Physical Exercise and Cognitive Training | Physical Exercise Intervention: The physical exercise portion of the combined intervention consists of 45 minutes of multi-modal physical exercise focused on seated aerobic and progressive resistance training designed to improve aerobic capacity, muscular strength and endurance consistent with current exercise recommendations. The study team will deliver 3 sessions per week for 3 months. Cognitive Intervention: The cognitive portion of the combined intervention consists of a suite of 24 programs called Brain HQ developed by Posit Science Inc., organized into six categories: attention, speed, memory, people skills, intelligence, and navigation. The DDD-ECT trial will use 45-minute sessions of Brain HQ exercises. The modules are designed to improve time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory. Physical Exercise Intervention: In home exercise intervention. Cognitive Training Intervention: Online cognitive training modules. |
| FG001 | Physical Exercise and Cognitive Control | Physical Exercise Intervention: The physical exercise portion of the combined intervention consists of 45 minutes of multi-modal physical exercise focused on seated aerobic and progressive resistance training designed to improve aerobic capacity, muscular strength and endurance consistent with current exercise recommendations. The study team will deliver 3 sessions per week for 3 months. Cognitive Control: This consists of up to 20 minutes of puzzles and games, 2 days per week for 3 months. The participants will use on-line Brain HQ Control Games hosted by Posit Science, Inc. as an attention control. Physical Exercise Intervention: In home exercise intervention. Cognitive Control: Online control puzzles and games. |
| FG002 | Cognitive Training and Stretching Control | Stretching Control: This consists of up to 10 minutes of gentle stretching. The study team will deliver 3 sessions per week for 3 months. Cognitive Intervention: The cognitive portion of the combined intervention consists of a suite of 24 programs called Brain HQ developed by Posit Science Inc., organized into six categories: attention, speed, memory, people skills, intelligence, and navigation. The DDD-ECT trial will use 45-minute sessions of Brain HQ exercises. The modules are designed to improve time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory. ly directing one session per week and available as needed for rest of the sessions. Cognitive Training Intervention: Online cognitive training modules. Stretching Control: In home stretching. |
| FG003 | Cognitive Control and Stretching Control | Stretching Control: This consists of up to 10 minutes of stretching. The study team will deliver 3 sessions per week for 3 months. Cognitive Control: This consists of up to 20 minutes of puzzles and games, 2 days per week for 3 months. The participants will use on-line Brain HQ Control Games hosted by Posit Science, Inc. as an attention control. Stretching Control: In home stretching. Cognitive Control: Online control puzzles and games. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Physical Exercise and Cognitive Training | Physical Exercise Intervention: The physical exercise portion of the combined intervention consists of 45 minutes of multi-modal physical exercise focused on seated aerobic and progressive resistance training designed to improve aerobic capacity, muscular strength and endurance consistent with current exercise recommendations. The study team will deliver 3 sessions per week for 3 months. Cognitive Intervention: The cognitive portion of the combined intervention consists of a suite of 24 programs called Brain HQ developed by Posit Science Inc., organized into six categories: attention, speed, memory, people skills, intelligence, and navigation. The DDD-ECT trial will use 45-minute sessions of Brain HQ exercises. The modules are designed to improve time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory. Physical Exercise Intervention: In home exercise intervention. Cognitive Training Intervention: Online cognitive training modules. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cognitive Status Outcome at 6 Months | The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) will measure cognitive status. The z-scores for the subscales have a mean of 0 and standard deviation of 1. The overall z-score is the mean of the 7-item z-scores. Z-scores above the standard deviation represent better cognitive outcomes. | Only participants who were able to complete the scale are included in the analysis. | Posted | Mean | Standard Deviation | Z-score | 6 months post study randomization |
|
Participants were assessed for adverse events from the time of informed consent process completion until the end of study participation. This was approximately 6 months if the study was completed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Physical Exercise and Cognitive Training | Physical Exercise Intervention: The physical exercise portion of the combined intervention consists of 45 minutes of multi-modal physical exercise focused on seated aerobic and progressive resistance training designed to improve aerobic capacity, muscular strength and endurance consistent with current exercise recommendations. The study team will deliver 3 sessions per week for 3 months. Cognitive Intervention: The cognitive portion of the combined intervention consists of a suite of 24 programs called Brain HQ developed by Posit Science Inc., organized into six categories: attention, speed, memory, people skills, intelligence, and navigation. The DDD-ECT trial will use 45-minute sessions of Brain HQ exercises. The modules are designed to improve time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory. Physical Exercise Intervention: In home exercise intervention. Cognitive Training Intervention: Online cognitive training modules. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| elevated heart rate | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| elevated heart rate | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Babar Khan, MD, MS | Indiana University | (317) 274-9132 | bakhan@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2022 | Dec 13, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 30, 2019 | Nov 10, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
| Cognitive Control and Stretching Control | Sham Comparator | Stretching Control: This consists of up to 10 minutes of stretching. The study team will deliver 3 sessions per week for 3 months. Cognitive Control: This consists of up to 20 minutes of puzzles and games, 2 days per week for 3 months. The participants will use on-line Brain HQ Control Games hosted by Posit Science, Inc. as an attention control. |
|
| Cognitive Training Intervention | Behavioral | Online cognitive training modules. |
|
|
| Stretching Control | Behavioral | In home stretching. |
|
| Cognitive Control | Behavioral | Online control puzzles and games. |
|
|
The Short Physical Performance Battery (SPPB) will measure physical training effects on balance and strength. Ranges from 0-12: higher score is better outcome |
| 6 month post study randomization |
| Cardiovascular Fitness Scores at 3 Months | The 2-Minute Step Test will measure physical training effects on cardiovascular fitness. Number of steps, higher = better outcome | 3 month post study randomization |
| Cardiovascular Fitness Scores at 6 Months | The 2-Minute Step Test will measure physical training effects on cardiovascular fitness. Number of steps, higher = better outcome | 6 month post study randomization |
| Depression Scores at 3 Months | The Patient Health Questionnaire-9 (PHQ-9) will measure intervention effects on depression levels. Ranges from 0-27, higher score is worse outcome | 3 month post study randomization |
| Depression Scores at 6 Months | The Patient Health Questionnaire-9 (PHQ-9) will measure intervention effects on depression levels. Ranges from 0-27, higher score is worse outcome | 6 month post study randomization |
| Anxiety Scores at 3 Months | The Generalized Anxiety Disorder Scale (GAD-7) will measure intervention effects on anxiety levels. Ranges from 0-21, higher score is worse outcome | 3 month post study randomization |
| Anxiety Scores at 6 Months | The Generalized Anxiety Disorder Scale (GAD-7) will measure intervention effects on anxiety levels. Ranges from 0-21, higher score is worse outcome | 6 month post study randomization |
| Quality of Life Scores at 3 Months | The Medical Outcomes Study 36 item short form (SF-36) will measure participant quality of life scores. range of 0 - 100 (higher = better outcome) | 3 month post study randomization |
| Quality of Life Scores at 6 Months | The Medical Outcomes Study 36 item short form (SF-36) will measure participant quality of life scores. range of 0 - 100 (higher = better outcome) | 6 month post study randomization |
| Carmel |
| Indiana |
| 46032 |
| United States |
| Indiana University Health Saxony Hospital | Fishers | Indiana | 46037 | United States |
| Eskenazi Health | Indianapolis | Indiana | 46202 | United States |
| Indiana University Health Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
| Indiana University Health University Hospital | Indianapolis | Indiana | 46202 | United States |
| Lost to Follow-up |
|
| refusal |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
| Death |
|
| BG001 | Physical Exercise and Cognitive Control | Physical Exercise Intervention: The physical exercise portion of the combined intervention consists of 45 minutes of multi-modal physical exercise focused on seated aerobic and progressive resistance training designed to improve aerobic capacity, muscular strength and endurance consistent with current exercise recommendations. The study team will deliver 3 sessions per week for 3 months. Cognitive Control: This consists of up to 20 minutes of puzzles and games, 2 days per week for 3 months. The participants will use on-line Brain HQ Control Games hosted by Posit Science, Inc. as an attention control. Physical Exercise Intervention: In home exercise intervention. Cognitive Control: Online control puzzles and games. |
| BG002 | Cognitive Training and Stretching Control | Stretching Control: This consists of up to 10 minutes of gentle stretching. The study team will deliver 3 sessions per week for 3 months. Cognitive Intervention: The cognitive portion of the combined intervention consists of a suite of 24 programs called Brain HQ developed by Posit Science Inc., organized into six categories: attention, speed, memory, people skills, intelligence, and navigation. The DDD-ECT trial will use 45-minute sessions of Brain HQ exercises. The modules are designed to improve time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory. ly directing one session per week and available as needed for rest of the sessions. Cognitive Training Intervention: Online cognitive training modules. Stretching Control: In home stretching. |
| BG003 | Cognitive Control and Stretching Control | Stretching Control: This consists of up to 10 minutes of stretching. The study team will deliver 3 sessions per week for 3 months. Cognitive Control: This consists of up to 20 minutes of puzzles and games, 2 days per week for 3 months. The participants will use on-line Brain HQ Control Games hosted by Posit Science, Inc. as an attention control. Stretching Control: In home stretching. Cognitive Control: Online control puzzles and games. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Physical Exercise and Cognitive Control | Physical Exercise Intervention: The physical exercise portion of the combined intervention consists of 45 minutes of multi-modal physical exercise focused on seated aerobic and progressive resistance training designed to improve aerobic capacity, muscular strength and endurance consistent with current exercise recommendations. The study team will deliver 3 sessions per week for 3 months. Cognitive Control: This consists of up to 20 minutes of puzzles and games, 2 days per week for 3 months. The participants will use on-line Brain HQ Control Games hosted by Posit Science, Inc. as an attention control. Physical Exercise Intervention: In home exercise intervention. Cognitive Control: Online control puzzles and games. |
| OG002 | Cognitive Training and Stretching Control | Stretching Control: This consists of up to 10 minutes of gentle stretching. The study team will deliver 3 sessions per week for 3 months. Cognitive Intervention: The cognitive portion of the combined intervention consists of a suite of 24 programs called Brain HQ developed by Posit Science Inc., organized into six categories: attention, speed, memory, people skills, intelligence, and navigation. The DDD-ECT trial will use 45-minute sessions of Brain HQ exercises. The modules are designed to improve time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory. ly directing one session per week and available as needed for rest of the sessions. Cognitive Training Intervention: Online cognitive training modules. Stretching Control: In home stretching. |
| OG003 | Cognitive Control and Stretching Control | Stretching Control: This consists of up to 10 minutes of stretching. The study team will deliver 3 sessions per week for 3 months. Cognitive Control: This consists of up to 20 minutes of puzzles and games, 2 days per week for 3 months. The participants will use on-line Brain HQ Control Games hosted by Posit Science, Inc. as an attention control. Stretching Control: In home stretching. Cognitive Control: Online control puzzles and games. |
|
|
|
| Primary | Cognitive Status Outcome at 3 Months | The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) will measure cognitive status. The z-scores for the subscales have a mean of 0 and standard deviation of 1. The overall z-score is the mean of the 7-item z-scores. Z-scores above the standard deviation represent better cognitive outcomes. | Only participants who were able to complete the scale are included in the analysis. | Posted | Mean | Standard Deviation | Z-score | 3 months post study randomization |
|
|
|
|
| Secondary | Physical Performance Scores at 3 Months | The Short Physical Performance Battery (SPPB) will measure physical training effects on balance and strength. Ranges from 0-12: higher score is better outcome | Only participants who were able to complete the scale are included in the analysis. Post COVID-19 no SPPB or 2 Minute Step Tests were performed. | Posted | Mean | Standard Deviation | score on a scale | 3 month post study randomization |
|
|
|
|
| Secondary | Physical Performance Scores at 6 Months | The Short Physical Performance Battery (SPPB) will measure physical training effects on balance and strength. Ranges from 0-12: higher score is better outcome | Only participants who were able to complete the scale are included in the analysis. Post COVID-19 no SPPB or 2 Minute Step Tests were performed. | Posted | Mean | Standard Deviation | score on a scale | 6 month post study randomization |
|
|
|
|
| Secondary | Cardiovascular Fitness Scores at 3 Months | The 2-Minute Step Test will measure physical training effects on cardiovascular fitness. Number of steps, higher = better outcome | Only participants who were able to complete the scale are included in the analysis. Post COVID-19 no SPPB or 2 Minute Step Tests were performed. | Posted | Mean | Standard Deviation | number of steps in place in 2 minutes | 3 month post study randomization |
|
|
|
|
| Secondary | Cardiovascular Fitness Scores at 6 Months | The 2-Minute Step Test will measure physical training effects on cardiovascular fitness. Number of steps, higher = better outcome | Only participants who were able to complete the scale are included in the analysis. Post COVID-19 no SPPB or 2 Minute Step Tests were performed. | Posted | Mean | Standard Deviation | number of steps in place in 2 minutes | 6 month post study randomization |
|
|
|
|
| Secondary | Depression Scores at 3 Months | The Patient Health Questionnaire-9 (PHQ-9) will measure intervention effects on depression levels. Ranges from 0-27, higher score is worse outcome | Posted | Mean | Standard Deviation | score on a scale | 3 month post study randomization |
|
|
|
|
| Secondary | Depression Scores at 6 Months | The Patient Health Questionnaire-9 (PHQ-9) will measure intervention effects on depression levels. Ranges from 0-27, higher score is worse outcome | Posted | Mean | Standard Deviation | score on a scale | 6 month post study randomization |
|
|
|
|
| Secondary | Anxiety Scores at 3 Months | The Generalized Anxiety Disorder Scale (GAD-7) will measure intervention effects on anxiety levels. Ranges from 0-21, higher score is worse outcome | Posted | Mean | Standard Deviation | score on a scale | 3 month post study randomization |
|
|
|
|
| Secondary | Anxiety Scores at 6 Months | The Generalized Anxiety Disorder Scale (GAD-7) will measure intervention effects on anxiety levels. Ranges from 0-21, higher score is worse outcome | Posted | Mean | Standard Deviation | score on a scale | 6 month post study randomization |
|
|
|
|
| Secondary | Quality of Life Scores at 3 Months | The Medical Outcomes Study 36 item short form (SF-36) will measure participant quality of life scores. range of 0 - 100 (higher = better outcome) | Posted | Mean | Standard Deviation | score on a scale | 3 month post study randomization |
|
|
|
|
| Secondary | Quality of Life Scores at 6 Months | The Medical Outcomes Study 36 item short form (SF-36) will measure participant quality of life scores. range of 0 - 100 (higher = better outcome) | Posted | Mean | Standard Deviation | score on a scale | 6 month post study randomization |
|
|
|
|
| 1 |
| 41 |
| 0 |
| 41 |
| 2 |
| 41 |
| EG001 | Physical Exercise and Cognitive Control | Physical Exercise Intervention: The physical exercise portion of the combined intervention consists of 45 minutes of multi-modal physical exercise focused on seated aerobic and progressive resistance training designed to improve aerobic capacity, muscular strength and endurance consistent with current exercise recommendations. The study team will deliver 3 sessions per week for 3 months. Cognitive Control: This consists of up to 20 minutes of puzzles and games, 2 days per week for 3 months. The participants will use on-line Brain HQ Control Games hosted by Posit Science, Inc. as an attention control. Physical Exercise Intervention: In home exercise intervention. Cognitive Control: Online control puzzles and games. | 2 | 41 | 1 | 41 | 3 | 41 |
| EG002 | Cognitive Training and Stretching Control | Stretching Control: This consists of up to 10 minutes of gentle stretching. The study team will deliver 3 sessions per week for 3 months. Cognitive Intervention: The cognitive portion of the combined intervention consists of a suite of 24 programs called Brain HQ developed by Posit Science Inc., organized into six categories: attention, speed, memory, people skills, intelligence, and navigation. The DDD-ECT trial will use 45-minute sessions of Brain HQ exercises. The modules are designed to improve time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory. ly directing one session per week and available as needed for rest of the sessions. Cognitive Training Intervention: Online cognitive training modules. Stretching Control: In home stretching. | 1 | 36 | 0 | 36 | 1 | 36 |
| EG003 | Cognitive Control and Stretching Control | Stretching Control: This consists of up to 10 minutes of stretching. The study team will deliver 3 sessions per week for 3 months. Cognitive Control: This consists of up to 20 minutes of puzzles and games, 2 days per week for 3 months. The participants will use on-line Brain HQ Control Games hosted by Posit Science, Inc. as an attention control. Stretching Control: In home stretching. Cognitive Control: Online control puzzles and games. | 3 | 35 | 0 | 35 | 0 | 35 |
| O2 saturation lower than 88% | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |