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临床试验/NCT06460740
NCT06460740招募中不适用

Combined Effects of 4-7-8 Breathing Technique and Stationary Cycle on Physical Performance, Quality of Life and Dyspnea in Post CABG Patients

Riphah International University2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
58
试验地点
2
主要终点
Physical Performance 6MWT

研究概览

简要总结

To determine the combined effects of 4-7-8 breathing technique and stationary cycle on physical performance, quality of life and dyspnea in post CABG patients.

详细描述

Patients who meet the inclusion criteria and will be excluded from the exclusion criteria will be recruited by convenient sampling technique and will be allocated to simple randomization process. By taking a sample of 58 patients through non-probability convenience sampling and randomly assigning them into two groups, Group A and Group B for 18 exercise sessions per month (four to five times in a week), out of which group A will receive 4-7-8 breathing technique and stationary cycle (n=29). Group B will alone receive Stationary cycle (n=29). The study will be Single-blind where patients will be only blind. Pre and post treatment training outcomes of physical performance will be measured through 6-minute walk test, quality of life will be measured through Short-item 36 (SF-36) questionnaire 2.0 version and dyspnea will be measured through modified Borg scale. The data will be analyzed through SPSS version 26. Generalized active range of motion will be given to both groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Only the patients will be blind its a single blind study

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who underwent a successful CABG (no complications during surgery
  • and/or in the following weeks)
  • Female and male whose age between 40 to 70 years of age
  • Phase II cardiac rehab patients
  • Patients who were extubated and hemodynamically stable
  • Patients with stable chronic heart failure.
  • Patients had no arrhythmias
  • Patients who had ability to read and write
  • Patients who voluntarily participated in the study.

排除标准

  • Ventricular Septal defect repair.
  • Patients have limitation of motion that prevents them from performing physical activities such as walking for 6 minute.
  • Patients who had undergone previous cardiac surgery.
  • Severe renal dysfunction requiring dialysis.
  • Altered level of consciousness.
  • A history of musculoskeletal problems
  • Having an orthopedic problem that prevents the use of lower and upper extremity bikes.
  • Cancer patients receiving radiotherapy and chemotherapy.
  • Clinical diagnosis of uncontrolled Diabetes Mellitus and Hypertension.
  • Physical Discomfort at any stage of the study and/or any reaction to the tests (nausea, dizziness, discomfort, feeling faint, tachycardia, excessive sweating), and if they failed to attend the scheduled sessions.

结局指标

主要结局

Physical Performance 6MWT

时间窗: 4th week

Changes from baseline The 6-minute walk test (6MWT) was developed by American Thoracic society and was officially introduced in 2002, coming along with a comprehensive guideline. The 6MWT is an easy, safe, reliable and simple cardiopulmonary sub maximal functional testing modality, used to assess functional capacity and to evaluate the cardiac and pulmonary rehabilitation treatment or intervention. (16) The individuals were requested to walk as far-off as they are able to on a smooth area for about 6 minutes. Individuals were permitted to take a rest or stop from walking if it was required then continue again as quick as they can. The distance covered by individuals for this test was measured in meters.

次要结局

  • SF-36 Quality of Life Questionnaire version 2.0(4th week)
  • Modified Borg Dyspnea Scale(4th week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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