The Effects of Observer Presence and Type on Patients' Perception of Exercise After Bone Tumor Resection-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 who have undergone bone tumor resection. The secondary aim of the study is to identify the barriers to starting exercise in these patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Bone Cancer; Tumor
• Intervention / Treatment: Other: Supervised Exercise by a physiotherapist via face to face; Other: Supervised Exercise by a physiotherapist via video conference

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34854
    • Emel Mete
    • Principal Investigator: Nilufer Kablan, PhD
    • Sub-Investigator: Korhan OZKAN, Professor

Participation Criteria

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 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

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 within the pain limit for the joints associated with the surgery area, and strengthening exercises for the non-surgical areas.	Other: Supervised Exercise by a physiotherapist via face to face; The exercises are performed by the participants under the supervision of a physiotherapist via face-to-face.
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 within the pain limit for the joints associated with the surgery area, and strengthening exercises for the non-surgical areas.	Other: Supervised Exercise by a physiotherapist via video conference; The exercises are performed by the participants under the supervision of a physiotherapist via video conference.
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	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

• Sponsor: Istanbul Medeniyet University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 15, 2022
• Primary Completion (Anticipated): February 2, 2023
• Study Completion (Anticipated): March 2, 2023

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: exercise; bone cancer; telerehabilitation
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Bone Diseases; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Sarcoma; Bone Neoplasms; Osteosarcoma
• Other Study ID Numbers: 2022/0179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No