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

NCT05397522 | Unknown

• 1 other identifier: 2022/0179
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Cancer; Tumor

Keywords

bone cancer; exercise; telerehabilitation

Outcome Measures

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.

  Change from baseline Patients' Perception of Exercise at week 6

Study Arms (3)

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

EXPERIMENTAL

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

EXPERIMENTAL

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

Control group: Unsupervised exercise

NO INTERVENTION

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

Supervised Exercise by a physiotherapist via face to face OTHER

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

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

Supervised Exercise by a physiotherapist via video conference OTHER

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

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Emel Mete

Istanbul, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bone Neoplasms; Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: 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).

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: May 31, 2022
• Study Start: August 15, 2022
• Primary Completion: February 2, 2023
• Study Completion: March 2, 2023
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

TU (1)