Clinical Trials Directory

Trials / Terminated

TerminatedNCT05554159

A Virtually Delivered Exercise Intervention To Mitigate Cognitive Deficits From Radiotherapy In AYAs With Brain Tumors

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
10 (actual)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
All
Age
15 Years – 39 Years
Healthy volunteers
Not accepted

Summary

To test a new investigational virtual exercise program for adolescents and young adults (AYAs) with brain tumors who plan to receive cranial radiotherapy

Detailed description

Primary Objective: Determine the feasibility and acceptability of a virtually supervised exercise intervention compared to control in AYAs with brain tumors undergoing cranial radiotherapy (CRT). Secondary Objective: Assess the effect of supervised exercise intervention on the neuroanatomic structure and cognitive function changes in AYAs with brain tumors undergoing CRT. Exploratory Objective: Assess the effect of supervised exercise intervention on other brain structure (white matter integrity), cognitive functions (attention, visual learning, psychomotor function, executive function, verbal learning, working memory and clinician-reported neurological exam outcomes), patient-reported health-related quality of life, objectively measured and patient-reported physical activity level, patient-reported dietary recall, objectively measured physical function assessments, and exercise progression (exercise volume). Assess the agreement between physical function tests performed twice virtually.

Conditions

Interventions

TypeNameDescription
BEHAVIORALStandard Fitbit ProgramParticipants will be given a Fitbit to wear during their participation in this program. Participants will need to wear the Fitbit at least 5 days per week and for at least 10 hours a day. Participants will take part in video calls (through the video conferencing platform Zoom) 1 time a week.
BEHAVIORALVirtual Exercise ProgramParticipants will be given a Fitbit to wear during their participation in this program. Participants will need to wear the Fitbit at least 5 days per week and for at least 10 hours a day. Participants will take part in video calls (through the video conferencing platform Zoom) 1 time a week.

Timeline

Start date
2023-06-05
Primary completion
2025-07-28
Completion
2025-07-28
First posted
2022-09-26
Last updated
2025-08-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05554159. Inclusion in this directory is not an endorsement.