Telerehabilitation in Women With Rheumatic Disease

Sponsor

Hasan Kalyoncu University (Other)

Overall Status

Completed

CT.gov ID

NCT05321901

Collaborator

(none)

Enrollment

Location

Arms

12.3

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatic Disease	Other: Biopsychosocial Exercise Therapy approach (BETY) Other: Control group	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 7, 2020

Actual Primary Completion Date :

Nov 19, 2021

Actual Study Completion Date :

Dec 17, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change from Baseline in Health Assessment Questionnaire at 8 weeks [Baseline, 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 [Baseline, 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 [Baseline, 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts 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.