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

Soft Tissue Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05596565
• Other study ID #: Qualitative study-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 10, 2022
• Est. completion date: September 10, 2023

Study information

• Verified date: October 2022
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 10, 2023
• Est. primary completion date: July 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Individuals aged between 18 and 65,

• Individuals without communication problems,

• Individuals who have been diagnosed with soft tissue sarcoma

• ECOG score =2

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

Other:
• Supervised Exercise by a physiotherapist via face to face
Participants in group-1 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. Participants in group-2 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

Locations

Country	Name	City	State
Turkey	Emel Mete	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Semi-structured focus group interviews about Patients' Perception of Exercise	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.	Change from baseline Patients' Perception of Exercise at week 6