Impact of Cognitive Rehab and Physical Activity on Cognition in Patients With Metastatic Brain Tumors Undergoing RT

Virginia Commonwealth University (VCU)

Status: Terminated

Conditions: Metastatic Brain Tumor; Cerebral Metastases

Treatments: Behavioral: Physical Activity; Behavioral: Cognitive rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03096431

MCC-16-13082

HM20007924 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A potential subject must meet all of the following inclusion criteria to be eligible to participate in the study:
• Ability to understand and the willingness to provide written informed consent
• 18 years of age and older
• Diagnosed with one or more metastatic brain tumor(s)
• Medical treatment plan includes whole-brain radiation therapy and / or sterotactic radiosurgery

Exclusion criteria

• A potential subject who meets any of the following exclusion criteria is ineligible to participate in the study.
• Diagnosis of dementia or unable to grant their own informed consent
• Prisoner or patient in custody
• Patient on psychiatric hold
• Physically unable to participate in the study
• The opinion of the treating physician determines it is not medically safe to participate in the study
• Pre-registration screen of cognition is "severe" or lower.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2 participants in 3 patient groups

Arm 1: Physical activity intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Physical Activity

Arm 2:Physical activity and cognitive intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Physical Activity

Behavioral: Cognitive rehabilitation

Arm 3: Cognitive and begin physical activity intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Physical Activity

Behavioral: Cognitive rehabilitation