Telerehabilitation in Women With Rheumatic Disease
Effects of a Telerehabilitation Program Based on Biopsychosocial Approach in Women With Rheumatic Disease
1 other identifier
interventional
35
1 country
1
Brief Summary
This study aims to investigate the effectiveness of the Biopsychosocial Exercise Therapy Approach (BETY), which is a biopsychosocial model, on daily living activities, anxiety, depression, and biopsychosocial conditions through telerehabilitation in rheumatic patients who could not go to the clinics during the COVID-19 pandemic.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2021
CompletedFirst Submitted
Initial submission to the registry
April 3, 2022
CompletedFirst Posted
Study publicly available on registry
April 11, 2022
CompletedApril 22, 2022
April 1, 2022
12 months
April 3, 2022
April 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change from Baseline in Health Assessment Questionnaire at 8 weeks
The Turkish version of the Health Assessment Questionnaire (HAQ), which is frequently used in patients with rheumatism, was used to evaluate their health and disability status. This questionnaire consists of 20 questions that collect activities of daily living under 8 activity titles, and each answer is given a score between 0 and 3. (0; No difficulty, 1; With some difficulty, 2: With great difficulty, 3: Not at all). To calculate the total score, these scores are added and divided by 8 based on the highest score in all sections. A high score is interpreted negatively.
Baseline, 8 weeks
Change from Baseline in Health Anxiety and Depression Scale at 8 weeks
The Turkish version of the Health Anxiety and Depression Scale (HADS) was used to evaluate depression and anxiety levels. This scale consists of 14 questions, focusing on the last few days. Each question has 4 options. Odd-numbered questions are used for anxiety, even-numbered questions are used to evaluate depression, and 2 separate scores are obtained that can take values between 0-21. While the critical value for anxiety in the sub-title of the scale was 10, it was determined to be 7 for depression.
Baseline, 8 weeks
Change from Baseline in Biopsychosocial Exercise Therapy Questionnaire (BETY-BQ) at 8 weeks
The Biopsychosocial Exercise Therapy Questionnaire (BETY-BQ), consists of 30 questions. Each of the items in the scale is scored between 0-4 in accordance with the Likert system. A higher score indicates poor biopsychosocial status (4: Yes always, 3: Yes often, 2: Yes sometimes, 1: Yes rarely, 0: No, never).
Baseline, 8 weeks
Study Arms (2)
Experimental Group: Telerehabilitation assisted exercise program
ACTIVE COMPARATORThe telerehabilitation-assisted exercise program included a Biopsychosocial Exercise Therapy approach (BETY). The approaches that make up the BETY innovation are grouped under 4 headings: Patient education on chronic pain, functional body stabilization exercises (mind-body information management), dance therapy-authentic movement (emotion-state information management), and sexual information management. Tele-rehabilitation group participated in the sessions that lasted for one and a half hours, 3 days a week for 8 weeks, over the Whatsapp group. The investigators, who provided supervision during the sessions, also participated in the exercises simultaneously.
Control Group
OTHERThe control group participants were those who did not want to receive exercise treatment with telerehabilitation and took their routine medications during the 8 weeks period.
Interventions
The BETY intervention is grouped under 4 headings: Patient education on chronic pain, functional body stabilization exercises (mind-body information management), dance therapy-authentic movement (emotion-state information management), and sexual information management.
The control group participants were those who did not want to receive exercise treatment with telerehabilitation and took their routine medications during the 8 weeks period.
Eligibility Criteria
You may qualify if:
- Participants diagnosed with rheumatic disease,
- Participants knew the exercises before attending BETY sessions,
- Participants who could participate in telerehabilitation by following WhatsApp communication were included in the exercise group.
You may not qualify if:
- Participants with neurological and psychological disorders,
- severe respiratory failure, fractures, infections, cancer, and musculoskeletal pain due to surgery in the last 6 months,
- Vision loss,
- Pregnancy
- Participants who did not agree to volunteer were not included in our study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hasan Kalyoncu University
Gaziantep, 27410, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Aysenur Tuncer, PhD
Hasan Kalyoncu University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 3, 2022
First Posted
April 11, 2022
Study Start
December 7, 2020
Primary Completion
November 19, 2021
Study Completion
December 17, 2021
Last Updated
April 22, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share