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临床试验/NCT05596565
NCT05596565尚未招募不适用

The Effects of Observer Presence and Type on Patients' Perception of Exercise in Patients With Soft Tissue Sarcoma -A Qualitative Study

Istanbul Medeniyet University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年11月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Semi-structured focus group interviews about Patients' Perception of Exercise

研究概览

简要总结

The primary aim of the study is to investigate the effects of supervised exercise, telerehabilitation and home-based exercise on patient perception in patients with soft tissue sarcoma. The secondary aim of the study is to identify the barriers to starting exercise in these patients.

详细描述

An exploratory-descriptive qualitative study will be conducted. There will be three groups in the study with each of them will consist of ten participants. Within the scope of the study, each group will perform a similar exercise program, 2 sessions a week, for 6 weeks, in one of the 3 groups below; Group 1: Exercising under the supervision of a face-to-face physiotherapist, Group 2: Exercise under the observation of the physiotherapist via video-conference (telerehabilitation), Group 3: Exercising in the absence of the observer (home based exercise program). The exercises to be applied to the groups will include breathing exercises, passive range of motion exercises and strengthening exercises. Semi-structured focus group interviews will be held with the participants twice, before and after the 6-week exercise program. In the semi-structured focus group interviews, the same questions will be asked to all participants and the verbal answers to these questions will be recorded with voice recorders. Compared to taking notes by hand; It will be preferable to record the conversation with a voice recorder because it has advantages such as recording all the interviews and allowing the interviewer to focus on the interview. In the pre-exercise interview, questions will be asked to determine the patient's views about exercises and the barriers to starting the exercise. In the interview held at the end of the exercise program, questions will be asked to learn the views/perceptions of the patients about the results of the exercise program. Thematic analysis method will be used in the evaluation of the data.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Individuals aged between 18 and 65,
  • •Individuals without communication problems,
  • •Individuals who have been diagnosed with soft tissue sarcoma
  • •ECOG score ≤2

排除标准

  • •Uncontrollable arrhythmia and/or hypertension
  • •Presence of advanced sensory deficit
  • •Visual and hearing problems
  • •Not having sufficient communication skills (Mini Mental Test score below 24 points)
  • •ECOG score>2

研究组 & 干预措施

Experimental group 1

Experimental

Supervised Exercise by a physiotherapist via face to face Participants in this group will be included in an exercise program for 6 weeks, 2 days a week and 45 minutes each session with supervised by a physiotherapist via face to face. The exercises will focus on breathing exercises, passive range of motion exercises and strengthening exercises.

干预措施: Supervised Exercise by a physiotherapist via face to face (Other)

Experimental group 2

Experimental

Supervised Exercise by a physiotherapist via video conference Participants in this group will be included in an exercise program for 6 weeks, 2 days a week and 45 minutes each session with supervised by a physiotherapist via video conference. The exercises will focus on breathing exercises, passive range of motion exercises and strengthening exercises.

干预措施: Supervised Exercise by a physiotherapist via face to face (Other)

Control group

No Intervention

No Intervention: Control group: Unsupervised exercise Home based exercises will be explained to the patients and they will be asked to perform these exercises 2 days a week for 6 weeks.

结局指标

主要结局

Semi-structured focus group interviews about Patients' Perception of Exercise

时间窗: Change from baseline Patients' Perception of Exercise at week 6

Semi-structured focus group interviews will be held with the participants twice, before and after the 6-week exercise program. . In the semi-structured focus group interviews, the same questions will be asked to all participants and the verbal answers to these questions will be recorded with voice recorders. In the pre-exercise interview, questions will be asked to determine the patient's views about exercises and the barriers to starting the exercise. In the interview held at the end of the exercise program, questions will be asked to learn the views/perceptions of the patients about the results of the exercise program.

次要结局

未报告次要终点

研究者

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

Emel Mete

Research Assistant

Istanbul Medeniyet University

研究点 (1)

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