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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001412 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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This project is focused on conducting a home-based, thinking while moving exercise intervention for adults 65 years or older, who have mild cognitive impairment, that will integrate several effective training modalities including non-contact cardio-kickboxing, stepping exercise, balance/functional training, and muscle strengthening. Cognitive function, physical function, and dual-task abilities will be assessed over the 12-week intervention and comparisons will be made between participants in the exercise intervention and control participants receiving no intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual-Task Training | Experimental | Dual-Task Exercise |
|
| Control | No Intervention | No Exercise |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual-Task Exercise Training | Behavioral | Simultaneous cognitive-motor training |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Balance: Left Limb | Change in performance on the Four-Stage Balance Test: Left Limb. Minimum value: 0 seconds Maximum value: 10 seconds Higher score = better performance | Pre-test (time 0) and End point (12 weeks) |
| Change in Balance: Right Limb. | Change in performance on the Four-Stage Balance Test: Right Limb. Minimum value: 0 seconds Maximum value: 10 seconds Higher score = better performance | Pre-test (time 0) and End point (12 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo, SUNY | Buffalo | New York | 14203 | United States |
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Recruitment took place from September 1st 2021 through May 21st, 2022 in local community centers, churches, and senior centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dual-Task Training | Receives video-guided, home-based dual-task exercise |
| FG001 | Control | Receives no exercise guidance |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dual-Task Training | Dual-Task Exercise Training: Simultaneous cognitive-motor training |
| BG001 | Control | Received no exercise guidance |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Balance: Left Limb | Change in performance on the Four-Stage Balance Test: Left Limb. Minimum value: 0 seconds Maximum value: 10 seconds Higher score = better performance | Older adults with MCI. | Posted | Median | Inter-Quartile Range | Seconds | Pre-test (time 0) and End point (12 weeks) |
|
3 months
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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 | Dual-Task Training | Dual-Task Exercise Training: Simultaneous cognitive-motor training |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nikhil Satchidanand | SUNY at Buffalo | 7168162884 | ns1@buffalo.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 | Feb 7, 2024 | Sep 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
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|
|
| Primary | Change in Balance: Right Limb. | Change in performance on the Four-Stage Balance Test: Right Limb. Minimum value: 0 seconds Maximum value: 10 seconds Higher score = better performance | Older adults with MCI | Posted | Median | Inter-Quartile Range | seconds | Pre-test (time 0) and End point (12 weeks) |
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| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Control | Control Group receives no intervention | 0 | 7 | 0 | 7 | 0 | 7 |
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