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

October 24, 2022 updated by: Emel Mete, Istanbul Medeniyet University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Emel Mete
        • Principal Investigator:
          • Nilufer Kablan, PhD
        • Contact:
          • EMEL METE, MSc
        • Sub-Investigator:
          • Korhan OZKAN, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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

Other Names:
  • Supervised Exercise by a physiotherapist via video conference
Experimental: 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.
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

Other Names:
  • Supervised Exercise by a physiotherapist via video conference
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Semi-structured focus group interviews about Patients' Perception of Exercise
Time Frame: 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.
Change from baseline Patients' Perception of Exercise at week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medeniyet University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 10, 2022

Primary Completion (Anticipated)

July 10, 2023

Study Completion (Anticipated)

September 10, 2023

Study Registration Dates

First Submitted

October 24, 2022

First Submitted That Met QC Criteria

October 24, 2022

First Posted (Actual)

October 27, 2022

Study Record Updates

Last Update Posted (Actual)

October 27, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Qualitative study-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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