- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05568485
Telerehabilitation in Individuals With Rheumatic Disease
October 11, 2022 updated by: Sevim Öksüz, Eastern Mediterranean University
Biopsychosocial Exercise Model Via Telerehabilitation in Individuals With Rheumatic Disease During the COVID-19 Pandemic
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Famagusta, Cyprus, 99450
- Eastern Mediterranen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telerehabilitation
Telerehabilitation was applied to the group with rheumatism
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BETY Biopsychosocial Questionnaire (BETY-BQ
Time Frame: change will be assessed at 12th week and 24th week
|
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
|
change will be assessed at 12th week and 24th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health assessment questionnaire
Time Frame: change will be assessed at 12th week and 24th week
|
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
|
change will be assessed at 12th week and 24th week
|
|
hospital qnxiety and depression scale
Time Frame: change will be assessed at 12th week and 24th week
|
. 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
|
change will be assessed at 12th week and 24th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zeynep İrem Bulut, MSc. Pt., Hasan Kalyoncu University
- Principal Investigator: Nur Banu Karaca, MSc. PT., Hacettepe University
- Principal Investigator: Arzu Dağ, İstanbul Yeni Yüzyıl University
- Study Director: Yavuz Yakut, Prof.Dr., Hasan Kalyoncu University
- Study Director: Sedat Kiraz, Prof. Dr., Hacettepe University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 10, 2020
Primary Completion (Actual)
December 20, 2021
Study Completion (Actual)
December 20, 2021
Study Registration Dates
First Submitted
September 22, 2022
First Submitted That Met QC Criteria
October 4, 2022
First Posted (Actual)
October 5, 2022
Study Record Updates
Last Update Posted (Actual)
October 13, 2022
Last Update Submitted That Met QC Criteria
October 11, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO-18/1182
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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