Trials / Recruiting
RecruitingNCT06788886
Breathing Practice for Brain and Mental Health in Cancer and Neurodegenerative Diseases
Enhancing Brain and Mental Health Through Respiratory Training: Clinical Applications in Cancer and Neurodegenerative Disease Care for Patients and Caregivers (Breathing Study)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 147 (estimated)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
PRIMARY OBJECTIVE: I. To evaluate the immediate and long-term effects of improved respiratory function on local tissue oxygen delivery and cerebral circulation, by comparing control and training groups. SECONDARY OBJECTIVE: I. To identify key biological aspects of breathing related to brain health and mental well-being, our research explores how respiratory function can improve clinical symptoms related to fatigue and emotional states. EXPLORATORY OBJECTIVE: I. To establish a clinically applicable support tool that uses effective breathing practice to help patients, and their caregivers better navigate their clinical treatment. OUTLINE: Participants are assigned to 1 of 3 studies. STUDY 1: Participants are randomized to 1 of 2 groups. GROUP 1: 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. At month 4, participants are randomized to 1 of 2 subgroups. SUBGROUP 1: Participants 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. SUBGROUP 2: Participants discontinue breathing self-practice routines for the additional 2 months on study. Participants also undergo MRI scans throughout the study. GROUP 2: 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. At month 4, participants are randomized to 1 of 2 subgroups. SUBGROUP 3: Participants 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. SUBGROUP 4: Participants 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. STUDY 2: 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. STUDY 3: 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. At month 4, participants are randomized to 1 of 2 subgroups. SUBGROUP 5: MS patients 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. SUBGROUP 6: MS patients discontinue breathing self-practice routines for the additional 2 months on study. Patients also undergo MRI scans and blood sample collection throughout the study.
Conditions
- Malignant Brain Neoplasm
- Malignant Solid Neoplasm
- Multiple Sclerosis
- Neuroendocrine Tumor
- Prostate Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Biospecimen Collection | Undergo blood sample collection |
| OTHER | Exercise Intervention | Participate in walking routines |
| PROCEDURE | Magnetic Resonance Imaging | Undergo MRI |
| OTHER | Questionnaire Administration | Ancillary studies |
| PROCEDURE | Respiratory Therapy | Participate in breathing sessions |
Timeline
- Start date
- 2025-02-05
- Primary completion
- 2027-01-18
- Completion
- 2027-01-18
- First posted
- 2025-01-23
- Last updated
- 2025-12-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06788886. Inclusion in this directory is not an endorsement.