Telerehabilitation in Women With Rheumatic Disease

Effects of a Telerehabilitation Program Based on Biopsychosocial Approach in Women With Rheumatic Disease

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.

Study Overview

• Status: Completed
• Conditions: Rheumatic Disease
• Intervention / Treatment: Other: Biopsychosocial Exercise Therapy approach (BETY); Other: Control group

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Gaziantep, Turkey, 27410
    • Hasan Kalyoncu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Experimental Group: Telerehabilitation assisted exercise program; 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.	Other: Biopsychosocial Exercise Therapy approach (BETY); 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.
OTHER: Control Group; 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.	Other: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hasan Kalyoncu University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 7, 2020
• Primary Completion (ACTUAL): November 19, 2021
• Study Completion (ACTUAL): December 17, 2021

Study Registration Dates

• First Submitted: April 3, 2022
• First Submitted That Met QC Criteria: April 3, 2022
• First Posted (ACTUAL): April 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Chronic pain; COVID-19; Telerehabilitation; Rheumatic diseases; Biopsychosocial Approach
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Rheumatic Diseases; Collagen Diseases
• Other Study ID Numbers: 2020/106

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