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临床试验/NCT05876507
NCT05876507招募中不适用

The Effects of Progressive Exercises on the Vital Signs and Fatigue in Patients With Renal Transplant

Baskent University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2023年2月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
52
试验地点
1
主要终点
fatigue level

研究概览

简要总结

The goal of this interventional study is to determine the effect of progressive relaxation exercises on the vital signs and fatigue levels of patients with renal transplantation.

详细描述

Renal transplant patients experience intense level of fatigue as well as vital sign problems due to treatment protocol. This research is designed to determine the effect of progressive relaxation exercises on vital signs and fatigue level of patients with renal transplantation.

In this study, the participants will be randomized in a single blind manner (participant) to either intervention (4 week exercise program) or control (routine care) groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients underwent renal transplant within one year from the beginning of the study
  • •Patients having no communication problems
  • •Patients having a smart phone either own or o family member

排除标准

  • •Patients having musculoskeletal, cardiopulmonary, or psychiatric disorders

研究组 & 干预措施

exercise

Experimental

Participants will receive a training about progressive relaxation exercises on the first day, then given an audio-record containing instructions about exercises. They will perform exercises at home for 4 week and revisited by the principal investigator at the 2nd and 4th week.

干预措施: Progressive relaxation exercise (Behavioral)

Control

No Intervention

Participants will receive routine care.

结局指标

主要结局

fatigue level

时间窗: Change from baseline at 4th week

Fatigue Severity Scale is a valid and 7-point Likert type scale. Possible scores range from 9-63. Higher scores indicate high level of fatigue. A score of 36 points or over indicates severe fatigue (Change= Lower score from the scale at the end of intervention compared to baseline).

Heart rate

时间窗: Change from baseline at 4th week

Maintaining or normalizing heart rate within normal range (60 to 100 bpm)

Systolic and diastolic blood pressure

时间窗: Change fron baseline at 4th week

Maintaining or normalizing systolic and blood pressure within normal range (systolic: 90-140 mmHg; diastolic 60-90 mmHg)

Respiratory rate

时间窗: Change from baseline at 4th week

Maintaining or normalizing respiratory rate within normal range (12-20 breath per minute)

Body temperature

时间窗: Change from baseline at 4th week

Maintaining or normalizing body temperature within normal range (36-37 C° in tympanic measurement)

Oxygen saturation

时间窗: Change from baseline at 4th week

Maintaining or normalizing oxygen saturation within normal range (between 95%-100% by pulse oximetry)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Seyda Uzun Yagız

Registered nurse

Baskent University

研究点 (1)

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