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

NCT ID: NCT05397522

Last Updated: 2022-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-15

Study Completion Date

2023-03-02

Brief Summary

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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

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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.

Conditions

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Bone Cancer Tumor

Keywords

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bone cancer exercise telerehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Supervised Exercise by a physiotherapist via face to face

Intervention Type OTHER

The exercises are performed by the participants under the supervision of a physiotherapist via face-to-face.

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.

Group Type EXPERIMENTAL

Supervised Exercise by a physiotherapist via video conference

Intervention Type OTHER

The exercises are performed by the participants under the supervision of a physiotherapist via video conference.

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

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Medeniyet University

OTHER

Sponsor Role lead

Responsible Party

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Emel Mete

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Emel Mete

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Facility Contacts

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EMEL METE

Role: primary

Other Identifiers

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2022/0179

Identifier Type: -

Identifier Source: org_study_id