跳至主要内容
临床试验/NCT05321901
NCT05321901已完成不适用

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

Hasan Kalyoncu University2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2020年12月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
2
主要终点
Change from Baseline in Health Assessment Questionnaire at 8 weeks

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Change from Baseline in Health Assessment Questionnaire at 8 weeks

时间窗: 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

时间窗: 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

时间窗: 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).

次要结局

未报告次要终点

研究者

发起方
Hasan Kalyoncu University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Erkin Oğuz SARI

Principal Investigator

Hasan Kalyoncu University

研究点 (2)

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