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

NCT ID: NCT05596565

Last Updated: 2022-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-10
• Study Completion Date: 2023-09-10

Brief 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.

Detailed 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.

Conditions

Soft Tissue Sarcoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental group 1

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.

Group Type: EXPERIMENTAL

Supervised Exercise by a physiotherapist via face to face

Intervention Type: OTHER

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

Experimental group 2

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.

Group Type: EXPERIMENTAL

Supervised Exercise by a physiotherapist via face to face

Intervention Type: OTHER

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

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Other Intervention Names

Supervised Exercise by a physiotherapist via video conference

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medeniyet University

OTHER

Sponsor Role: lead

Responsible Party

Emel Mete

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Emel Mete

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Facility Contacts

EMEL METE, MSc

Role: primary

Other Identifiers

Qualitative study-2

Identifier Type: -

Identifier Source: org_study_id