Breathing Practice for Brain and Mental Health in Cancer and Neurodegenerative Diseases

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

STUDY 1: Participants must be physically fit enough to perform light exercise.

STUDY 1: Should read and understand English well enough to consent, complete measures, and follow instructions.

STUDY 1: Must have access to a smartphone or tablet.

STUDY 2: Participants must be physically fit enough to perform light exercise.

Disqualifiers

STUDY 1: Participants incompatible with MRI machines due to factors such as pacemakers or metallic implants.

STUDY 1: Additionally, those with chronic medical conditions, including heart disease (coronary artery disease, congestive heart failure, hypertension, cardiac arrhythmia), chronic obstructive pulmonary disease (COPD), cystic fibrosis, cancer, diabetes, sleep apnea, aneurysms, and neurological conditions (epilepsy, Alzheimer's disease, Huntington' disease, essential tremor and Parkinson disease) are excluded.

STUDY 1: Participants with psychiatric conditions such as psychosis, suicidality, bipolar disorder, major depression, and substance use disorders are excluded.

STUDY 1: Participants serving as caregivers for any of the aforementioned conditions and for other illnesses such as cancer or neurological disorders, are also excluded.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Exercise Intervention

    Other intervention

    Participate in walking routines

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Respiratory Therapy

    Procedure/Surgery

    Participate in breathing sessions

Treatment groups

147 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Study 1 Group 1, Subgroup 1 (6 month breathing sessions)Experimental treatment 3 interventions
Group B: Study 1 Group 1, Subgroup 2 (4 month breathing sessions)Experimental treatment 3 interventions
Group C: Study 1 Group 2, Subgroup 3 (6 month walking routines)Active comparator 3 interventions
Group D: Study 1 Group 2, Subgroup 4 (walking + breathing)Experimental treatment 4 interventions
Group E: Study 2 (4 month breathing sessions)Experimental treatment 3 interventions
Group F: Study 3 Subgroup 5 (6 month breathing sessions)Experimental treatment 4 interventions
Group G: Study 3 Subgroup 6 (4 months breathing sessions)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Changes in respiratory function correlated with brain activity

Assessed using advanced imaging techniques (such as MRI) and physiological analyses. The approach to data analysis will involve a detailed examination of the MRI data collected from each participant. Respiratory data will be correlated with neuroimaging findings to provide a comprehensive view of how respiratory patterns may influence brain activity.

Time frame
Baseline up to 6 months

Secondary outcomes

1

Change in QOL - PHQ-9

Assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 consists of 9 questions related to problems experienced over the past 2 weeks. Questions are answered on a scale of 0-3 where 0=Not at all; 1=several days; 2=more than half the days, and 3=nearly every day.

Time frame
Baseline up to 6 months
2

Change in QOL - GAD-7

Assessed using the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 consists of 7 questions related to problems experienced over the past 2 weeks. Questions are answered on a scale of 0-3 where 0=Not at all; 1=several days; 2=more than half the days, and 3=nearly every day.

Time frame
Baseline up to 6 months
3

Change in QOL - Linear Analog Self Assessment

Assessed using the Linear Analog Self Assessment, which consists of 5 questions related to feeling related to well being experienced over the past week. Questions are answered on a scale ranging from 0-10 where 0=as bad as it can be and 10=as good as it can be.

Time frame
Baseline up to 6 months
4

Adherence to the breathing protocol for the intention group

Time frame
Up to 6 months

Other outcomes

Sponsors and contacts

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