Yogic Breathing Exercise and Meditation for People With Spinal Cord Disorders
The goal of the study is to understand how well yogic breathing exercise and meditation improves breathing, fatigue, emotional well-being and quality of life in people with spinal cord disorders.
Aim 1. Evaluate the efficacy of an 8-week, virtual, coach-guided yogic breathing and meditation (YBM) program on QoL and mental health in people with spinal cord disorders.
This study will include completing several questionnaires 3 times, 8 weeks of participating in 2 sessions per week of yogic breathing exercise and meditation via Zoom and being interviewed once at the completion of the 8-week program.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
General Information You are being asked to take part in a research study. This research study is voluntary, meaning you do not have to take part in it. The procedures, risks, and benefits are fully described further in the consent form.
Purpose The purpose of the study is to understand how well yogic breathing exercise and meditation improves breathing, fatigue, and emotional well-being in people with spinal cord injury (SCI).
Duration & Visits You will complete several questionnaires (3 different times) that will take 30 minutes to complete each time, participate in 12-30-minute yogic breathing exercise and meditation sessions (over 8 weeks), complete a 25-minute interview and that you will be in the study for 2 months.
Overview of Procedures This study will include completing several questionnaires multiple times, 8 weeks of participating in 2 sessions per week of yogic breathing exercise and meditation via Zoom and being interviewed once.
Risks The most common risks include some tiredness and frustration while learning the yogic breathing exercise and meditation techniques. Loss of confidentiality is also a risk.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Hon Yuen, PhD
- Telefonnummer: 12059346301
- E-post: yuen@uab.edu
Studer Kontakt Backup
- Navn: Adrian Smith, BS
- Telefonnummer: 12059348931
- E-post: adrian02@uab.edu
Studiesteder
-
-
Alabama
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Birmingham, Alabama, Forente stater, 35294
- Rekruttering
- University of Alabama at Birmingham
-
Hovedetterforsker:
- Hon Yuen, PhD
-
Ta kontakt med:
- Hon Yuen, PhD
- Telefonnummer: 2059346301
- E-post: yuen@uab.edu
-
Ta kontakt med:
- Adrian Smith, BS
- Telefonnummer: 2059348931
- E-post: adrian02@uab.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- spinal cord disorders
- community-dwelling adults aged ≥ 18 years
- able to follow simple, three-step verbal instructions (e.g., close your eyes, open your mouth, close your mouth)
- access to the internet and an electronic device with videoconferencing capability
- able to set up virtual sessions with/without caregiver assistance
- sufficient English language proficiency to provide consent for study participation and complete self-report questionnaires
Exclusion Criteria:
- suicidal intent requiring emergency care
- bedridden with continuous use of noninvasive ventilation
- participating in weekly pulmonary PT, psychological therapy, or a clinical trial that could affect proposed study outcomes.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: yogic breathing and meditation
yogic breathing exercise and meditation exercise
|
yogic breathing exercise and meditation exercise
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Depressive symptoms as assessed by the PHQ-9
Tidsramme: change from baseline in depressive symptoms at 8 and 16 weeks
|
The Patient Health Questionnaire-9 (PHQ-9) consists of nine questions inquiring about symptoms experienced over the past two weeks, ranging from low energy and sleep issues to feelings of hopelessness and self-harm.
Each question is scored from 0 to 3, with a maximum total score of 27.
Higher scores indicate more severe depressive symptomology.
|
change from baseline in depressive symptoms at 8 and 16 weeks
|
|
Patient health questionnaire (PHQ-9)
Tidsramme: baseline, post-program (8th week), and 16th week
|
The Patient Health Questionnaire-9 (PHQ-9) consists of nine questions inquiring about symptoms experienced over the past two weeks, ranging from low energy and sleep issues to feelings of hopelessness and self-harm.
Each question is scored from 0 to 3, with a maximum total score of 27.
Higher scores indicate more severe depressive symptomology.
|
baseline, post-program (8th week), and 16th week
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Hon Yuen, PhD, University of Alabama at Birmingham
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB-300011535 A
- UAB (Annen identifikator: UAB)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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