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| ID | Type | Description | Link |
|---|---|---|---|
| HM20007924 | Other Identifier | IRB |
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PI leaving institution: Will not continue study.
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To determine the feasibility of processes and instruments with an overarching purpose to guide the design of a larger study. To determine the feasibility of individuals with metastatic brain tumor(s) to engage in physical activity(PA) and cognitive rehabilitation (CR) as in an outpatient therapy setting.
Rolling recruitment for the study. Participants will be randomized into one of three treatment arms. All treatment arms will undergo physical & cognitive testing prior to whole-brain radiation therapy (WBRT)/stereotactic radiosurgery (SRS). Arm 3 will receive cognitive rehabilitation intervention sessions prior to, and concurrent with, WBRT/SRS. Approximately 14 days following WBRT/SRS: all arms will undergo physical and cognitive testing, and: Arm 1 will begin physical activity intervention. Arm 2 will begin physical activity intervention and cognitive intervention. Arm 3 will continue with cognitive intervention and begin physical activity intervention. All Arms will undergo physical and cognitive testing approximately 2.5 months post WBRT/SRS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Physical activity intervention | Active Comparator | Undergo baseline testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. 14 days (± 2 days) following WBRT/SRS: all arms undergo testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Arm 1: intervention of physical activity begins. 60 days (± 5 days) post testing after WBRT/SRS: all arms undergo final testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. |
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| Arm 2:Physical activity and cognitive intervention | Active Comparator | Undergo baseline testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. 14 days (± 2 days) following WBRT/SRS: all arms undergo testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Arm 2: intervention of both cognitive rehabilitation and physical activity begins. 60 days (± 5 days) post testing after WBRT/SRS: all arms undergo final testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. |
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| Arm 3: Cognitive and begin physical activity intervention | Active Comparator | Undergo baseline testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Arm 3: Intervention of cognitive rehabilitation begins prior to and is concurrent with WBRT/SRS treatment. 14 days (± 2 days) following WBRT/SRS: all arms undergo testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. Arm 3: continue intervention of cognitive rehabilitation; add intervention of physical activity. 60 days (± 5 days) post testing after WBRT/SRS: all arms undergo final testing of physical (lower body strength, endurance) and cognitive (executive functioning) abilities. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Activity | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment percentage of eligible subjects. | Recruitment: success defined as enrollment rate of 19% of eligible subjects. | 18.5 months |
| Retention percentage of participants at end-of-study. | Retention: success defined as retention rate above 56% at end-of-study. | 18.5 months |
| Non-attendance rates of participants. instructions. | Participant missed or cancelled therapy sessions less than 15% of time. | 18.5 months |
| Lengths of sessions completed. | Participant completed full scheduled minutes per session ≥ 80% of time. | 18.5 months |
| Percentage of completion of Physical Activity intervention tasks. | Participant completed ≥ 80% of PA interventions (required < 20% rest period during or between tasks). | 18.5 months |
| Percentage of Cognitive Therapy intervention tasks. | Participant completed ≥ 80% of CR interventions (required < 20% rest period during or between tasks). | 18.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive abilities. | Composite score post-CR intervention, minus the composite score at baseline. Scores of zero indicates maintained cognition. Positive scores indicate improved cognition. Negative scores indicate declined cognition. Composite scores derived from the following four standardized tests:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne F. Taylor, PhD, MBA, OTR/L | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | 23298-0037 | United States |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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All participants will be blinded to the study design and will be randomized into one of three treatment arms. Research assistant is blinded to both the study design and to which arm the participants are randomized.
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| Cognitive rehabilitation | Behavioral | One-to-one intervention: 45 minutes sessions with licensed therapist to include graded cognitive tasks designed to improve executive functioning with focus on both restorative and compensatory approaches. |
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| 18.5 months |
| Change in physical abilities. | Composite scores post intervention minus scores at baseline. Scores of zero indicate maintained physical abilities. Positive scores indicate improved physical abilities. Negative scores indicate declined physical abilities. Composite scores derived from the following two standardized tests:
| 18.5 months |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001519 | Behavior |
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |