Enhancing Brain and Mental Health Through Respiratory Training: Clinical Applications in Cancer and Neurodegenerative Disease Care for Patients and Caregivers (Breathing Study)

RecruitingNot a drug-phase studyMS (type not specified)NCT06788886

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Biospecimen Collection
  • Respiratory Therapy

Given to everyone in the trial

  • Exercise Intervention
  • Magnetic Resonance Imaging
  • Questionnaire Administration

What it measured

Main measures

  • Changes in respiratory function correlated with brain activity

    Baseline up to 6 months

    MRI lesions

Other measures (10)

  • Change in QOL - PHQ-9

    Baseline up to 6 months

    Quality of life (reported by participants)
  • Change in QOL - GAD-7

    Baseline up to 6 months

    Mood and sleepQuality of life (reported by participants)
  • Change in QOL - Linear Analog Self Assessment

    Baseline up to 6 months

    Quality of life (reported by participants)
  • Adherence to the breathing protocol for the intention group

    Up to 6 months

    Quality of life (reported by participants)
  • Change in sleep quality - PSQI

    Baseline up to 6 months

    Walking and mobilityMood and sleep
  • Change in sleepiness - ESS

    Baseline up to 6 months

    Mood and sleep
  • Change in fatigue - MFIS

    Baseline up to 6 months

    Fatigue
  • Change in caregiver strain - CSI

    Baseline up to 6 months

  • Change in resilience - BRS

    Baseline up to 6 months

  • Change in ability to implement health-promoting behaviors - SRAHP

    Baseline up to 6 months

    Physical function

Who could take part

MS (type not specified) · 18 to 85

Show the full criteria

Inclusion criteria

* 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. * STUDY 2: Cancer patients may have prostate cancer, neuroendocrine tumor, or brain cancer in any stage. * STUDY 2: The main focus is on pairs of cancer patients and their respective caregivers, but individual cancer patients or individual caregivers are also acceptable. * STUDY 2: Participants should read and understand English well enough to consent, complete measures, and follow instructions. * STUDY 2: They also must have access to a smartphone or tablet. * STUDY 3: Participants must be physically fit enough to perform light exercise. * STUDY 3: The patient should have multiple sclerosis. * STUDY 3: Participants should read and understand English well enough to consent, complete measures, and follow instructions. * STUDY 3: They also must have access to a smartphone or tablet.

Exclusion criteria

* 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. * STUDY 1: Further exclusions apply to those with severe vision, hearing impairments, have a body mass index (BMI) over 30, and those who are pregnant. * STUDY 1: Those planning to become pregnant during the study period will be excluded. * STUDY 2: Participants incompatible with MRI machines due to factors such as pacemakers or metallic implants are excluded, as are those with chronic lung disease (chronic obstructive pulmonary disease [COPD], cystic fibrosis), aneurysms, and those who are pregnant. * STUDY 2: Those planning to become pregnant during the study period will be excluded. * STUDY 3: Participants incompatible with MRI machines due to factors such as pacemakers or metallic implants are excluded, as are those with chronic lung disease (chronic obstructive pulmonary disease [COPD], cystic fibrosis), aneurysms, and those who are pregnant. * STUDY 3: Those planning to become pregnant during the study period will be excluded.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

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History

    1. Started

      Feb 2025

    2. Main results due

      Jan 2027

    3. Finished

      Jan 2027

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