Telerehabilitation in Individuals With Rheumatic Disease
Primary Purpose
Rheumatic Diseases
Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Telerehabilitation was applied to the group with rheumatism
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatic Diseases focused on measuring Biopsychosocial, rheumatology, remote care, holistic
Eligibility Criteria
Inclusion Criteria:
members of an exercise group before the pandemic at the physiotherapy and rehabilitation department of a university.
Exclusion Criteria:
- Individuals who had difficulty in cooperation
Sites / Locations
- Eastern Mediterranen University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Telerehabilitation
Arm Description
Telerehabilitation was applied to the group with rheumatism
Outcomes
Primary Outcome Measures
BETY Biopsychosocial Questionnaire (BETY-BQ
an assessment tool that evaluates biopsychosocial involvement and assesses pain, function, sexual behavior, and social and psychological aspects. The scoring of the questionnaire is made using a 5-point Likert system. Each item is scored as "0 = No, never, 1 = Yes, rarely, 2 = Yes, sometimes, 3 = Yes, often, or 4 = Yes, always". A high score indicates a low biopsychosocial status
Secondary Outcome Measures
Health assessment questionnaire
It includes 20 questions and 8 components including dressing, sitting, eating, walking, hygiene, reaching out, comprehending, and activities of daily living. Each answer is rated between 0 and 3 points, "0 = No difficulty, 1 = Somewhat difficult, 2 = Very difficult, and 3 = I can never do it", and a high score indicates low functionality [18]. HAQ scores of >1 are considered to indicate the presence of disability
hospital qnxiety and depression scale
. It is a 14-item scale that consists of Anxiety (HADS-A) and Depression (HADS-D) subscales. The answer to each item is scored between 0 and 3 using the 4-point Likert scoring format, and each subscale has a score range between 0 and 21. Scores between 0 and 7 for each subscale are considered "normal", those between 8 and 10 are considered "mild anxiety/depression", and those from 11 to 21 are considered moderate-severe anxiety/depression
Full Information
NCT ID
NCT05568485
First Posted
September 22, 2022
Last Updated
October 11, 2022
Sponsor
Eastern Mediterranean University
1. Study Identification
Unique Protocol Identification Number
NCT05568485
Brief Title
Telerehabilitation in Individuals With Rheumatic Disease
Official Title
Biopsychosocial Exercise Model Via Telerehabilitation in Individuals With Rheumatic Disease During the COVID-19 Pandemic
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 10, 2020 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
December 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Mediterranean University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
increasing the prevalence of exercise models designed in accordance with the biopsychosocial model is very important in terms of ensuring the sustainability of these models with telerehabilitation in periods such as epidemics and pandemics. The aim of this study was to investigate the effects of a biopsychosocial exercise model provided via telerehabilitation in individuals with rheumatic diseases during the COVID-19 pandemic.
Detailed Description
Telerehabilitation was applied to the group with rheumatism in 3 sessions a week for 24 weeks via a social texting program. The intervention sessions consisted of 10 minutes of dance therapy-authentic movement, 40 minutes of exercises, and 10 more minutes of dance therapy. This exercise content was based on a biopsychosocial model, named the Cognitive Exercise Therapy Approach (BETY) which was used in the study, and it was a method that patients already practiced before the pandemic. At the beginning, at the 12th week and 24th week, the Health Assessment Questionnaire (HAQ), the Hospital Anxiety and Depression Scale (HADS), the BETY Biopsychosocial Questionnaire (BETY-BQ) were applied.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Diseases
Keywords
Biopsychosocial, rheumatology, remote care, holistic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telerehabilitation
Arm Type
Experimental
Arm Description
Telerehabilitation was applied to the group with rheumatism
Intervention Type
Other
Intervention Name(s)
Telerehabilitation was applied to the group with rheumatism
Intervention Description
Telerehabilitation was applied to the group with rheumatism in 3 sessions a week for 24 weeks via a social texting program. The intervention sessions consisted of 10 minutes of dance therapy-authentic movement, 40 minutes of exercises, and 10 more minutes of dance therap
Primary Outcome Measure Information:
Title
BETY Biopsychosocial Questionnaire (BETY-BQ
Description
an assessment tool that evaluates biopsychosocial involvement and assesses pain, function, sexual behavior, and social and psychological aspects. The scoring of the questionnaire is made using a 5-point Likert system. Each item is scored as "0 = No, never, 1 = Yes, rarely, 2 = Yes, sometimes, 3 = Yes, often, or 4 = Yes, always". A high score indicates a low biopsychosocial status
Time Frame
change will be assessed at 12th week and 24th week
Secondary Outcome Measure Information:
Title
Health assessment questionnaire
Description
It includes 20 questions and 8 components including dressing, sitting, eating, walking, hygiene, reaching out, comprehending, and activities of daily living. Each answer is rated between 0 and 3 points, "0 = No difficulty, 1 = Somewhat difficult, 2 = Very difficult, and 3 = I can never do it", and a high score indicates low functionality [18]. HAQ scores of >1 are considered to indicate the presence of disability
Time Frame
change will be assessed at 12th week and 24th week
Title
hospital qnxiety and depression scale
Description
. It is a 14-item scale that consists of Anxiety (HADS-A) and Depression (HADS-D) subscales. The answer to each item is scored between 0 and 3 using the 4-point Likert scoring format, and each subscale has a score range between 0 and 21. Scores between 0 and 7 for each subscale are considered "normal", those between 8 and 10 are considered "mild anxiety/depression", and those from 11 to 21 are considered moderate-severe anxiety/depression
Time Frame
change will be assessed at 12th week and 24th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
members of an exercise group before the pandemic at the physiotherapy and rehabilitation department of a university.
Exclusion Criteria:
Individuals who had difficulty in cooperation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeynep İrem Bulut, MSc. Pt.
Organizational Affiliation
Hasan Kalyoncu University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nur Banu Karaca, MSc. Pt.
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arzu Dağ
Organizational Affiliation
İstanbul Yeni Yüzyıl University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yavuz Yakut, Prof.Dr.
Organizational Affiliation
Hasan Kalyoncu University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sedat Kiraz, Prof. Dr.
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
Facility Information:
Facility Name
Eastern Mediterranen University
City
Famagusta
ZIP/Postal Code
99450
Country
Cyprus
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Telerehabilitation in Individuals With Rheumatic Disease
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