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Trial Title:
The Effects of Observer Presence and Type on Patients' Perception of Exercise in Patients With Soft Tissue Sarcoma
NCT ID:
NCT05596565
Condition:
Soft Tissue Sarcoma
Conditions: Official terms:
Sarcoma
Conditions: Keywords:
soft tissue sarcoma
exercise
Telerehabilitation
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention 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).
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Supervised Exercise by a physiotherapist via face to face
Description:
Participants in group-1 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.
Participants in group-2 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
Arm group label:
Experimental group 1
Arm group label:
Experimental group 2
Other name:
Supervised Exercise by a physiotherapist via video conference
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 with soft
tissue sarcoma. 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 and
strengthening exercises. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Individuals aged between 18 and 65,
- Individuals without communication problems,
- Individuals who have been diagnosed with soft tissue sarcoma
- ECOG score ≤2
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)
- ECOG score>2
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Emel Mete
Address:
City:
Istanbul
Country:
Turkey
Contact:
Last name:
EMEL METE, MSc
Investigator:
Last name:
Nilufer KABLAN, Phd
Email:
Principal Investigator
Investigator:
Last name:
Korhan Ozkan, Professor
Email:
Sub-Investigator
Start date:
November 10, 2022
Completion date:
September 10, 2023
Lead sponsor:
Agency:
Istanbul Medeniyet University
Agency class:
Other
Source:
Istanbul Medeniyet University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05596565
