- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07573683
Additional Effect of Coherent Breathing With Aerobic Exercise on Cardiopulmonary Parameters and Quality of Life in Stage 1 Hypertensive Individuals
This study will use a randomized controlled trial to evaluate the added effects of coherent breathing combined with aerobic exercise versus aerobic exercise alone in 40 adults aged 30-65 with stage 1 hypertension. Participants will be randomly assigned to an intervention group (aerobic exercise plus coherent breathing) or a control group (aerobic exercise only) and will undergo a 4-week program with 5 sessions per week.
Cardiopulmonary parameters-including blood pressure, heart rate, respiratory rate, and rate pressure product-will be measured, and quality of life will be assessed using the MINICHAL questionnaire at baseline, 2 weeks, and post-intervention. Data will be analyzed using SPSS version 21.0.
The study aims to determine whether coherent breathing provides additional benefits, offering a cost-effective, non-pharmacological strategy for hypertension management in low-resource settings.
연구 개요
상세 설명
Hypertension, also known as high or raised blood pressure, is a condition in which the blood vessels have persistently raised pressure. A normal reading is less than 120 millimeters of mercury over less than 80 millimeters of mercury. Hypertension is a prevalent condition affecting approximately 1.28 billion individuals globally, with a significant burden observed in low- and middle-income countries such as Pakistan. Stage 1 hypertension is defined by a systolic blood pressure (SBP) between 130-139 mmHg or diastolic blood pressure (DBP) between 80-89 mmHg. High blood pressure causes no signs or symptoms, which is why healthcare providers call it a "silent killer." Non-pharmacological interventions, including aerobic exercise and breathing techniques, have shown promise in improving cardiopulmonary function and quality of life.
Coherent breathing is a controlled breathing technique that involves inhaling and exhaling at a steady, slow pace-typically around five to six breaths per minute, with each inhale and exhale lasting about six seconds. This study aims to evaluate the additional effects of coherent breathing techniques when combined with aerobic exercise, compared to aerobic exercise alone. A randomized controlled trial design will be employed. The study will be conducted over a period of 1 year at Foundation University College of Physical Therapy and Fauji Foundation Hospital Rawalpindi. Ethical approval will be obtained from ERC FUMC and IRC, and the trial will be registered with CBRC and the clinical trial registry. Data will be analyzed using SPSS version 21.0.
This study will fill a critical gap in the literature by assessing the additive benefits of coherent breathing in hypertension management. The findings may support cost-effective, non-pharmacological strategies in low-resource settings, contributing to improved public health outcomes
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Kainat Zahra, MSPT-CPPT
- 전화번호: 03367343005
- 이메일: zahrakainat99@gmail.com
연구 연락처 백업
- 이름: Syeda Sumaira Batool, MSPT-CPT
- 전화번호: 03328868680
- 이메일: sumaira.batool@fui.edu.pk
연구 장소
-
-
-
Islamabad, 파키스탄
- 모병
- Foundation University Islamabad
-
연락하다:
- Syeda Sumaira Batool, MSPT-CPT
- 전화번호: 03328868680
- 이메일: sumaira.batool@fui.edu.pk
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Both male and female genders.
- Adults aged 30-65 years.
- Patients diagnosed with stage 1 hypertension 130-139/80-89mm Hg according to ACC/AHA 2017 guidelines.
- Mild to moderate physical activity level on IPAQ questionnaire.
- Individuals able to understand and follow the instructions.
Exclusion Criteria:
- Diagnosed uncontrolled hypertensive patients.
- Unstable angina, MI, heart failure, advanced CAD patients, COPD, Asthma.
- Severe neurological, musculoskeletal or gynecological conditions which limit participation in the study.
- Recent history of fracture.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Aerobic Exercises
This Group performs aerobic exercises as follows: Week 1-2 Warm up exercises for 5 minutes. Brisk walking on treadmill-for 15 minutes was included warm up period for 5 minutes then 9 minutes brisk walk and cool down period included 1 minute walk. Stepper for 2 minutes. Static cycling for 3 minutes. Cool down for 5 minutes. Perform simple breathing for 10 minutes. FREQUENCY: 5 days / week INTENSITY: 50 - 60% THR TIME: 40 minutes TYPE: Aerobic exercises & simple breathing Week 3-4 Warm up exercises for 5 minutes. Brisk walking on treadmill-for 15 minutes was included warm up period for 5 minutes then 9 minutes brisk walk and cool down period included 1 minute walk. Stepper for 2 minutes. Static cycling for 3 minutes. Cool down for 5 minutes. Perform simple breathing exercies for 10 minutes. FREQUENCY: 5 days / week INTENSITY: 60 - 80% THR TIME: 40 minutes TYPE: Aerobic exercises & simple breathing. A total of 20 sessions Five days per week for 4 weeks. |
Aerobic Exercises involving brisk walking, warm up, stepper, static cycling, cool down for a periof of 30 min.
|
|
실험적: Aerobic Exercises with coherent breathing
This group performs aerobic exercises combined with coherent breathing technique. Week 1-2 Warm up exercises for 5 minutes. Brisk walking on treadmill-for 15 minutes was included warm up period for 5 minutes then 9 minutes brisk walk and cool down period included 1 minute walk. Stepper for 2 minutes. Static cycling for 3 minutes. Cool down for 5 minutes. Perform coherent breathing technique for 10 min. FREQUENCY: 5 days / week INTENSITY: 50 - 60% THR TIME: 30 minutes TYPE: Aerobic exercises. Coherent Breathing technique for 10 minutes. TOTAL DURATION: 40 minutes Week 3-4 Warm up exercises for 5 minutes. Brisk walking on treadmill-for 15 minutes was included warm up period for 5 minutes then 9 minutes brisk walk and cool down period included 1 minute walk. Stepper for 2 minutes. Static cycling for 3 minutes. Cool down for 5 minutes. Perform coherent breathing technique for 10 min. FREQUENCY: 5 days / week INTENSITY: 60 - 80% THR TIME: 30 minutes TYPE: Aerobic exercises |
Coherent breathing technique involve consciously reducing the breathing rate, typically to fewer than 10 breaths per minute, often around 6 breaths per minute. Coherent breathing is performed for 10 minutes. Aerobic Exercises involving brisk walking, warm up, stepper, static cycling, cool down for a period of 30 min. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Heart Rate (beats per minute)
기간: 04 weeks
|
Measured using calibrated digital monitor after 5 minutes rest at baseline and post-intervention.
|
04 weeks
|
|
Systolic Blood Pressure (mmHg)
기간: 04 weeks
|
Measured using standardized sphygmomanometer at baseline and post-intervention.
|
04 weeks
|
|
Diastolic Blood Pressure (mmHg)
기간: 04 weeks
|
Measured using standardized sphygmomanometer at baseline and post-intervention.
|
04 weeks
|
|
Peripheral Oxygen Saturation (SpO₂, %)
기간: 04 weeks
|
Measured using pulse oximeter under resting conditions at baseline and post-intervention.
|
04 weeks
|
|
Respiratory Rate (breaths/minute)
기간: 04 weeks
|
Measured by direct observation at baseline and post-intervention.
|
04 weeks
|
|
Rate Pressure Product (HR × SBP)
기간: 04 weeks
|
Calculated from heart rate and systolic blood pressure at baseline and post-intervention as an index of myocardial workload.
|
04 weeks
|
공동 작업자 및 조사자
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- FUCP/CTR/2026/06
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. .