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The Effects of Observer Presence and Type on Patients' Perception of Exercise After Bone Tumor Resection-A Qualitative Study

Primary Purpose

Bone Cancer, Tumor

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Supervised Exercise by a physiotherapist via face to face
Supervised Exercise by a physiotherapist via video conference
Sponsored by
Istanbul Medeniyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Cancer focused on measuring bone cancer, exercise, telerehabilitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Individuals aged between 18 and 65,
  • Individuals without communication problems,
  • Individuals who have been diagnosed with a bone tumor for the first time and who have undergone resection surgery

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)
  • Patients undergoing head and neck bone resection

Sites / Locations

  • Emel Mete

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Experimental group 1: Supervised Exercise by a physiotherapist via face to face

Experimental group-2: Supervised Exercise by a physiotherapist via video conference

Control group: Unsupervised exercise

Arm Description

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 within the pain limit for the joints associated with the surgery area, and strengthening exercises for the non-surgical areas.

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 within the pain limit for the joints associated with the surgery area, and strengthening exercises for the non-surgical areas.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 25, 2022
Last Updated
May 25, 2022
Sponsor
Istanbul Medeniyet University
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1. Study Identification

Unique Protocol Identification Number
NCT05397522
Brief Title
The Effects of Observer Presence and Type on Patients' Perception of Exercise After Bone Tumor Resection-A Qualitative Study
Official Title
The Effects of Observer Presence and Type on Patients' Perception of Exercise After Bone Tumor Resection-A Qualitative Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 15, 2022 (Anticipated)
Primary Completion Date
February 2, 2023 (Anticipated)
Study Completion Date
March 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 who have undergone bone tumor resection. 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 within the pain limit for the joints associated with the surgery area, and strengthening exercises for the non-surgical areas. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Cancer, Tumor
Keywords
bone cancer, exercise, telerehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model 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).
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group 1: Supervised Exercise by a physiotherapist via face to face
Arm Type
Experimental
Arm Description
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 within the pain limit for the joints associated with the surgery area, and strengthening exercises for the non-surgical areas.
Arm Title
Experimental group-2: Supervised Exercise by a physiotherapist via video conference
Arm Type
Experimental
Arm Description
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 within the pain limit for the joints associated with the surgery area, and strengthening exercises for the non-surgical areas.
Arm Title
Control group: Unsupervised exercise
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Supervised Exercise by a physiotherapist via face to face
Intervention Description
The exercises are performed by the participants under the supervision of a physiotherapist via face-to-face.
Intervention Type
Other
Intervention Name(s)
Supervised Exercise by a physiotherapist via video conference
Intervention Description
The exercises are performed by the participants under the supervision of a physiotherapist via video conference.
Primary Outcome Measure Information:
Title
Semi-structured focus group interviews about Patients' Perception of Exercise
Description
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.
Time Frame
Change from baseline Patients' Perception of Exercise at week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals aged between 18 and 65, Individuals without communication problems, Individuals who have been diagnosed with a bone tumor for the first time and who have undergone resection surgery 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) Patients undergoing head and neck bone resection
Facility Information:
Facility Name
Emel Mete
City
Istanbul
ZIP/Postal Code
34854
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
EMEL METE
Phone
05376096265
Email
e_emel86@hotmail.com
First Name & Middle Initial & Last Name & Degree
Nilufer KABLAN, PhD
First Name & Middle Initial & Last Name & Degree
Korhan OZKAN, Professor

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effects of Observer Presence and Type on Patients' Perception of Exercise After Bone Tumor Resection-A Qualitative Study

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