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临床试验/CTRI/2024/06/068230
CTRI/2024/06/068230进行中(未招募)1 期

Evaluation of Remote Phase-2 Cardiac Rehabilitation on Functional Capacity and Health-Related Quality of Life in Patients Post Valvular Heart Surgeries at Tertiary Care Hospital: A Quasi-experimental study

Physiotherapy school and center Seth G S Medcial college and KEMH1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月15日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
1.6-minute walk test

研究概览

简要总结

Introduction: Valvular heart disease that leads to obstruction or backwards flow of blood. Heart valve surgery is a well-known procedure. Patients undergoing heart valve surgery who have postoperative complications commonly present with impairment of physical activity and physical capacity up to several years before surgery combined with a period of bed rest, which leads to muscle weakness after surgery and affects their functional capacity and quality of life. Cardiac rehabilitation is a comprehensive programme that emphasises secondary prevention and lifestyle changes. Centre-based rehabilitation is the gold standard, but due to travel problems, financial problems, and limited resources, it is difficult to attend the exercise programme. Nowadays, smartphones and wearable devices are used to monitor exercises at home.

Aims and objectives: The study aims to evaluate the effects of remote phase 2 cardiac rehabilitation over usual care on functional capacity and quality of life in valvular heart surgery patients older than 18 to 60 years old.

Methodology: patients undergoing post-valvular Heart surgery will be included and written consent will be obtained. Patients are divided into 2 groups: the software-driven cardiac rehabilitation group and the usual care group.at discharge demographic data, 6 MWT, and Quality of life will be assessed. software-driven intervention group, Cardiac rehabilitation through the Digital Health app. Telephonic consultation is given once a week, an individual exercise programme will be made, relaxation videos will be given, and for the usual care group exercise programme, patient education will be given. A routine follow-up will be done. re-evaluation of both groups at 6 and 12 weeks at the end of the study, reassessment of 6MWT, And the quality of life will improve. The adherence and satisfaction of the remote intervention group will be measured.  The collected data will be analysed.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Elective left-sided or right-sided heart valve surgery (aortic, mitral, tricuspid, and pulmonary valve repair and replacement)
  • Double-valve surgery
  • Combined Valve + CABG surgery
  • Age between 18 and 60 years old
  • Both males and females were included.

排除标准

  • Cognitive impairments like dementia
  • Patients with left ventricular dysfunction.
  • Patients who had persistent or paroxysmal atrial fibrillation
  • Patients with unstable postoperative hemodynamics.
  • Patients who have any lower limb deformity due to which they are unable to walk
  • Participants who do not consent to participants.

结局指标

主要结局

1.6-minute walk test

时间窗: Baseline | 6 week | 12 week

2.EQ-5D Quality of life

时间窗: Baseline | 6 week | 12 week

次要结局

  • 1.Questionnaire for the satisfaction and adherence(Baseline)

研究者

发起方
Physiotherapy school and center Seth G S Medcial college and KEMH
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Mariya Jiandani

Seth G S Medical college and KEMH

研究点 (1)

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