The Effects of Observer Presence and Type on Patients' Perception of Exercise in Patients With Soft Tissue Sarcoma

NCT05596565 | Unknown

• 1 other identifier: Qualitative study-2
• 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 with soft tissue sarcoma. The secondary aim of the study is to identify the barriers to starting exercise in these patients.

Conditions

Soft Tissue Sarcoma

Keywords

soft tissue sarcoma; 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

EXPERIMENTAL

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 and strengthening exercises.

Other: Supervised Exercise by a physiotherapist via face to face

Experimental group 2

EXPERIMENTAL

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 and strengthening exercises.

Other: Supervised Exercise by a physiotherapist via face to face

Control group

NO INTERVENTION

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

Supervised Exercise by a physiotherapist via face to face OTHER

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

Also known as: Supervised Exercise by a physiotherapist via video conference

Experimental group 1; Experimental group 2

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 soft tissue sarcoma
• ECOG score ≤2

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)
• ECOG score\>2

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Emel Mete

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sarcoma; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; 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: October 24, 2022
• First Posted: October 27, 2022
• Study Start: November 10, 2022
• Primary Completion: July 10, 2023
• Study Completion: September 10, 2023
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)