Breathing Practice for Brain and Mental Health in Cancer and Neurodegenerative Diseases
Part of paid clinical trials in Rochester, Minnesota.
- Sponsor
- Mayo Clinic
- Study ID
- NCT06788886
- Status
- Recruiting
Conditions
- Malignant Brain Neoplasm
- Malignant Solid Neoplasm
- Multiple Sclerosis
- Neuroendocrine Tumor
- Prostate Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 85 Years
- Healthy Volunteers
- Accepted
Interventions
- Biospecimen Collection — PROCEDUREUndergo blood sample collection
- Exercise Intervention — OTHERParticipate in walking routines
- Magnetic Resonance Imaging — PROCEDUREUndergo MRI
- Questionnaire Administration — OTHERAncillary studies
- Respiratory Therapy — PROCEDUREParticipate in breathing sessions
Study Details
This clinical trial studies the effect of respiratory training for enhancing brain and mental health among patients with multiple sclerosis (MS) and cancer (along with their caregivers). The relationship between respiration, cardiovascular effects in the brain, mental health, and neurophysiological mechanisms are significant for patient populations facing complex health challenges, such as those with cancer and neurodegenerative disease, and their caregivers. By measuring oxygen delivery to brain tissues and cerebrospinal fluid flow, this trial may help researchers investigate the potential benefits of respiratory training for patients with MS and cancer and their caregivers.
Key Dates
- Start date
- Feb 5, 2025
- Status verified
- Jun 2026
- Primary completion
- Jan 18, 2027
- Completion
- Jan 18, 2027
Study Design
- Enrollment
- 147 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Study 1 Group 1, Subgroup 1 (6 month breathing sessions)Participants engage in breathing self-practice routines using a mobile app over 30 minutes daily for 4 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. Participants then engage in breathing self-practice routines using a mobile app over 30 minutes daily for an additional 2 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. Participants also undergo MRI scans throughout the study.
- Experimental: Study 1 Group 1, Subgroup 2 (4 month breathing sessions)Participants engage in breathing self-practice routines using a mobile app over 30 minutes daily for 4 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. Participants then discontinue breathing self-practice routines for the additional 2 months on study. Participants also undergo MRI scans throughout the study.
- Active Comparator: Study 1 Group 2, Subgroup 3 (6 month walking routines)Participants engage in walking self-practice routines using a mobile app over 30 minutes daily for 4 months on study. Participants may also participate in in-person group walking session with other participants weekly on study. Participants then engage in walking self-practice routines using a mobile app over 30 minutes daily for an additional 2 months on study. Participants may also participate in in-person group walking session with other participants weekly on study. Participants also undergo MRI scans throughout the study.
- Experimental: Study 1 Group 2, Subgroup 4 (walking + breathing)Participants engage in walking self-practice routines using a mobile app over 30 minutes daily for 4 months on study. Participants may also participate in in-person group walking session with other participants weekly on study. Participants then engage in walking self-practice routines using a mobile app over 30 minutes daily for an additional 2 months and also engage in breathing self-practice routines using a mobile app over 30 minutes daily for 2 months on study. Participants may also participate in in-person group walking session with other participants weekly on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. Participants also undergo MRI scans throughout the study.
- Experimental: Study 2 (4 month breathing sessions)Cancer patients and their caregivers engage in breathing self-practice routines using a mobile app over 30 minutes daily for 4 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. Participants also undergo MRI scans throughout the study.
- Experimental: Study 3 Subgroup 5 (6 month breathing sessions)MS patients engage in breathing self-practice routines using a mobile app over 30 minutes daily for 4 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. MS patients then engage in breathing self-practice routines using a mobile app over 30 minutes daily for an additional 2 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. Patients also undergo MRI scans and blood sample collection throughout the study.
- Experimental: Study 3 Subgroup 6 (4 months breathing sessions)MS patients engage in breathing self-practice routines using a mobile app over 30 minutes daily for 4 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. MS patients then discontinue breathing self-practice routines for the additional 2 months on study. Patients also undergo MRI scans and blood sample collection throughout the study.
Primary Outcome Measure
Changes in respiratory function correlated with brain activity [ Time Frame: Baseline up to 6 months ]
Central Contacts
- Clinical Trials Referral Office855-776-0015
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | Paul H. Min, PhD (PRINCIPAL_INVESTIGATOR) |
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