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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Hon Yuen, PhD
- 전화번호: 12059346301
- 이메일: yuen@uab.edu
연구 연락처 백업
- 이름: Adrian Smith, BS
- 전화번호: 12059348931
- 이메일: adrian02@uab.edu
연구 장소
-
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Alabama
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Birmingham, Alabama, 미국, 35294
- 모병
- University of Alabama at Birmingham
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수석 연구원:
- Hon Yuen, PhD
-
연락하다:
- Hon Yuen, PhD
- 전화번호: 2059346301
- 이메일: yuen@uab.edu
-
연락하다:
- Adrian Smith, BS
- 전화번호: 2059348931
- 이메일: adrian02@uab.edu
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: yogic breathing and meditation
yogic breathing exercise and meditation exercise
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yogic breathing exercise and meditation exercise
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Depressive symptoms as assessed by the PHQ-9
기간: 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.
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change from baseline in depressive symptoms at 8 and 16 weeks
|
|
Patient health questionnaire (PHQ-9)
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Hon Yuen, PhD, University of Alabama at Birmingham
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- IRB-300011535 A
- UAB (기타 식별자: UAB)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .