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Telerehabilitation in Women With Rheumatic Disease

Primary Purpose

Rheumatic Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Biopsychosocial Exercise Therapy approach (BETY)
Control group
Sponsored by
Hasan Kalyoncu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatic Disease focused on measuring Rheumatic diseases, Telerehabilitation, Chronic pain, COVID-19, Biopsychosocial Approach

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hasan Kalyoncu University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Experimental Group: Telerehabilitation assisted exercise program

Control Group

Arm Description

The 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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).

Secondary Outcome Measures

Full Information

First Posted
April 3, 2022
Last Updated
April 14, 2022
Sponsor
Hasan Kalyoncu University
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1. Study Identification

Unique Protocol Identification Number
NCT05321901
Brief Title
Telerehabilitation in Women With Rheumatic Disease
Official Title
Effects of a Telerehabilitation Program Based on Biopsychosocial Approach in Women With Rheumatic Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 7, 2020 (Actual)
Primary Completion Date
November 19, 2021 (Actual)
Study Completion Date
December 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
35 female participants with rheumatic disease were included in the study. Among the individuals who participated in face-to-face BETY sessions before, 23 individuals who agreed to exercise with telerehabilitation were divided into 2 groups, the exercise group, and 12 individuals in the control group. Group 1: Telerehabilitation group: Individuals in the telerehabilitation group attended sessions that lasted for one and a half hours, 3 days a week for 8 weeks, in the company of a physiotherapist over the Whatsapp group. The investigators, who provided supervision during the sessions, also participated in the exercises simultaneously. The investigators managed the individuals according to their exercise number and order, by reminding them of the exercises with explanatory messages and positive energy via Whatsapp group. The participation of the patients in the exercises was followed up with the answers they gave in the Whatsapp group. Patients who did not respond were called by phone and checked to see if they provided continuity. Both the exercise group and the control group continued their drug treatments during this period. Group 2: Control group: Individuals in the control group continued their routine drugs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Disease
Keywords
Rheumatic diseases, Telerehabilitation, Chronic pain, COVID-19, Biopsychosocial Approach

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group: Telerehabilitation assisted exercise program
Arm Type
Active Comparator
Arm Description
The 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.
Arm Title
Control Group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Biopsychosocial Exercise Therapy approach (BETY)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Health Assessment Questionnaire at 8 weeks
Description
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.
Time Frame
Baseline, 8 weeks
Title
Change from Baseline in Health Anxiety and Depression Scale at 8 weeks
Description
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.
Time Frame
Baseline, 8 weeks
Title
Change from Baseline in Biopsychosocial Exercise Therapy Questionnaire (BETY-BQ) at 8 weeks
Description
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).
Time Frame
Baseline, 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aysenur Tuncer, PhD
Organizational Affiliation
Hasan Kalyoncu University
Official's Role
Study Director
Facility Information:
Facility Name
Hasan Kalyoncu University
City
Gaziantep
ZIP/Postal Code
27410
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Telerehabilitation in Women With Rheumatic Disease

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