Telerehabilitation in Individuals With Rheumatic Disease

Sponsor

Eastern Mediterranean University (Other)

Overall Status

Completed

CT.gov ID

NCT05568485

Collaborator

(none)

Enrollment

Location

Arm

12.3

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatic Diseases	Other: Telerehabilitation was applied to the group with rheumatism	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Biopsychosocial Exercise Model Via Telerehabilitation in Individuals With Rheumatic Disease During the COVID-19 Pandemic

Actual Study Start Date :

Dec 10, 2020

Actual Primary Completion Date :

Dec 20, 2021

Actual Study Completion Date :

Dec 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Telerehabilitation Telerehabilitation was applied to the group with rheumatism	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

Arm

Intervention/Treatment

Experimental: Telerehabilitation

Telerehabilitation was applied to the group with rheumatism

Other: Telerehabilitation was applied to the group with rheumatism

Outcome Measures

Primary Outcome Measures

BETY Biopsychosocial Questionnaire (BETY-BQ [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

Secondary Outcome Measures

Health assessment questionnaire [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
hospital qnxiety and depression scale [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eastern Mediterranen University	Famagusta		Cyprus	99450

Sponsors and Collaborators

Eastern Mediterranean University

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sevim Öksüz, physiotherapist, Eastern Mediterranean University

ClinicalTrials.gov Identifier:

NCT05568485

Other Study ID Numbers:

GO-18/1182

First Posted:

Oct 5, 2022

Last Update Posted:

Oct 13, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sevim Öksüz, physiotherapist, Eastern Mediterranean University

Biopsychosocial, rheumatology, remote care, holistic

Additional relevant MeSH terms:

Rheumatic Diseases

Collagen Diseases

Study Results

No Results Posted as of Oct 13, 2022