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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05568485
Other study ID # GO-18/1182
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 10, 2020
Est. completion date December 20, 2021

Study information

Verified date October 2022
Source Eastern Mediterranean University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date December 20, 2021
Est. primary completion date December 20, 2021
Accepts healthy volunteers No
Gender All
Age group 45 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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

Locations

Country Name City State
Cyprus Eastern Mediterranen University Famagusta

Sponsors (1)

Lead Sponsor Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 change will be assessed at 12th week and 24th week
Secondary 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 change will be assessed at 12th week and 24th week
Secondary 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 change will be assessed at 12th week and 24th week
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