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临床试验/NCT07035340
NCT07035340已完成不适用

EFFECTS OF INSPIRATION MUSCLE TRAINING ON NT-PROBNP, FUNCTIONAL EXERCISE CAPACITY, DAILY LIVING EXERCISE PERFORMANCE, AND QUALITY OF LIFE IN PATIENTS UNDERGOING CARDIAC RESYNCHRONIZATION THERAPY

Tarsus University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年5月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
1
主要终点
NT-proBNP

研究概览

简要总结

Patients who are followed up in the cardiology clinic with a diagnosis of CHF, who have had a CRT implant at least 1 year ago, and who do not receive cardiac rehabilitation will be included. The aim of the study is to investigate the effects of inspiratory muscle training (IMT) on exercise capacity, respiratory muscle strength, NTproBNP and quality of life.

Groups Intervention group: Treatment with IMT Control group: Standard care Study hypothesis;

  1. Does IMT have an effect on exercise capacity and quality of life in patients with CRT?
  2. Does IMT have an effect on NTproBNP in patients with CRT?

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
None

盲法说明

Doctor who doing ekogardiography.

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who were followed up in the cardiology clinic with a diagnosis of CHF,
  • CRT implanted at least 1 year ago,
  • did not receive cardiac rehabilitation,
  • 45-75 years old,
  • communicate in Turkish,
  • NYHA II-III

排除标准

  • orthopedic and neurological disorders that may prevent walking,
  • acute respiratory tract infection in the last month,
  • NYHA I were not included in this study because they were generally not hospitalised and the problems were managed with outpatient diagnosis and treatment, and patients with class IV were not included in this study because they showed severe symptoms for medical and ethical reasons and they were not wanted to be forced with this long-lasting survey application process.

结局指标

主要结局

NT-proBNP

时间窗: enrollment and end of the 12 week treatment

NT-proBNP

Exercises capacity

时间窗: enrollment and end of the first week of treatment

Exercise capacity was evaluated using the 6-minute walk test (6MWT). 6MWT was performed according to the ATS/ERS criteria.

Heart rate (Exercises capacity)

时间窗: enrollment and end of the first week of treatment

Heart rate were measured using a portable pulse oximeter (Cosmed Srl, Cosmed Spiropalm, Rome, Italy), before, after and 1 minute recovery.

Quality of Life of patients

时间窗: enrollment and end of the 12 week treatment

Qality of life was assessed using the Nottingham Health Profile (NHP) self-reported tool. The NHP questionnaire evaluates six dimensions of health (pain, energy level, sleep, physical abilities, emotional reaction and social isolation) and includes 38 items. Total NHP score ranges between 0-600 and quality of life perception is negatively associated with score received

次要结局

  • Respiratory muscle strength(enrollment and end of the first week of treatment)
  • The performance of patients' activities of daily living(at enrollment and end of the 12 week treatment)

研究者

发起方
Tarsus University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nurel Ertürk

Phd,PT

Tarsus University

研究点 (1)

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