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Completed

NCT Number: NCT05321901

Telerehabilitation 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.

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Key information

Conditions

Rheumatic Disease COVID-19 Chronic Pain Connective Tissue Diseases Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Musculoskeletal Diseases Neurologic Manifestations Nidovirales Infections Pain Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Rheumatic Diseases Signs and Symptoms Skin and Connective Tissue Diseases Virus Diseases

Age range

35 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hasan Kalyoncu University

Gaziantep, 27410, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biopsychosocial Exercise Therapy approach (BETY)

Other

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.

Control Group

Other

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 outcomes

  1. Change from Baseline in Health Assessment Questionnaire at 8 weeks

    Time frame: 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.

  2. Change from Baseline in Health Anxiety and Depression Scale at 8 weeks

    Time frame: 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.

  3. Change from Baseline in Biopsychosocial Exercise Therapy Questionnaire (BETY-BQ) at 8 weeks

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Hasan Kalyoncu University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 11, 2022
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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