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Status unknownNCT05397522Updated May 31, 2022

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

An interventional study of Supervised Exercise by a physiotherapist via face to face and Supervised Exercise by a physiotherapist via video conference in Bone Cancer and Tumor, sponsored by Istanbul Medeniyet University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-05-31.

Sponsored by Istanbul Medeniyet University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bone Cancer
  • Tumor

Keywords

  • bone cancer
  • exercise
  • telerehabilitation
03

In context

Bone Neoplasms

322 studies on the registry are indexed under Bone Neoplasms; 81 are open to participants now.

This study's planned enrollment of 30 is below the median of 50 across 218 interventional studies indexed under Bone Neoplasms.

Browse Bone Neoplasms studies →

Lead sponsor

Istanbul Medeniyet University is the lead sponsor of 188 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • 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

  • 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

  • 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.

Interventions

  • OtherSupervised 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.

  • OtherSupervised Exercise by a physiotherapist via video conference

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from baseline Patients' Perception of Exercise at week 6

07

Study locations

1 site
  • Emel Mete
    Istanbul, 34854, Turkey
    • EMEL METE · Contact · e_emel86@hotmail.com · 05376096265
    • Nilufer KABLAN, PhD · Principal investigator
    • Korhan OZKAN, Professor · Sub investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05397522
Lead sponsor
Istanbul Medeniyet University
Responsible party
Emel Mete (Research Assistant, Istanbul Medeniyet University) — Principal investigator
First posted
May 31, 2022
Start date
Aug 15, 2022 (estimated)
Primary completion
Feb 2, 2023 (estimated)
Completion
Mar 2, 2023 (estimated)
Last update
May 31, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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