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临床试验/NCT05771376
NCT05771376已完成不适用

The Effects of Baduanjin Qigong Exercise Via Telerehabilitation in Ankylosing Spondylitis: A Randomized Controlled Study

Akdeniz University1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2022年2月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
1
主要终点
Chest expansion

研究概览

简要总结

The aim of this study is to examine the effectiveness of 12-week Baduanjin qigong exercises in patients with ankylosing spondylitis. 59 volunteer individuals, ages 18-64, will be included in the study. They will be randomly divided into two groups (the intervention and the control). The intervention group will perform a qigong exercise program online (via Zoom video conference) for 12 weeks under the supervision of two physiotherapists. The qigong exercise program had previously been videotaped by the researchers. The control group will perform the home exercise program at home for 12 weeks.

详细描述

This study will be conducted to examine the effect of Baduanjin qigong exercises on patients with ankylosing spondylitis. 29 individuals with ankylosing spondylitis (the intervention group) and 30 healthy individuals (the control group), totaling 59 volunteer individuals ages 18-64, will be included in the study.

The intervention group will perform a qigong exercise program online (via Zoom video conference) for 12 weeks under the supervision of two physiotherapists. The qigong exercise program had previously been videotaped by the researchers. The control group will perform the home exercise program at home for 12 weeks. The intervention group will perform Qigong online exercise program, and the control group will perform home exercises for 45 minutes twice a week for 12 weeks.

In this study the Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index, Bath Ankylosing Spondylitis Metrology Index, Chest Expansion Measurement, The Pittsburgh Sleep Quality Index, Fatigue Severity Scale, Hospital Anxiety and Depression Scale, and Ankylosing Spondylitis Quality of Life Questionnaire will be applied before and after the 12-week exercise program in the evaluation of patients.

研究设计

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

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with ankylosing spondylitis diagnosis

排除标准

  • Patients with another rheumatological diseases or orthopedic, neurological, psychiatric, cardiovascular, oncological comorbidities

结局指标

主要结局

Chest expansion

时间窗: 12 weeks

Chest expansion will be evaluated by chest expansion measurement. After measuring the chest circumference following a deep inspiration from the fourth intercostal space (at the level of the nipples), chest expansion is determined by measuring again after a forced expiration and taking the net difference between them. The average of two the correct measurements will be taken as the final measurement.

Ankylosing Spondylitis Quality of Life

时间窗: 12 weeks

Ankylosing Spondylitis Quality of Life Questionnaire-ASQoL will be used to evaluate the patient's quality of life. ASQoL questionnaire measures disease-specific quality of life.

Functional capacity

时间窗: 12 weeks

The functional capacity of the patient will be evaluated with The Bath Ankylosing Spondylitis Functional Index (BASFI). BASFI is a set of 10 questions designed to determine the degree of functional limitation in patients with Ankylosing Spondylitis (AS). The 10 questions were chosen with a major input from patients with AS. The first 8 questions are about everyday tasks and dependent on functional anatomy (bending, reaching, changing position, standing, turning, and climbing steps with or without rail) while the final 2 questions assess the patients' ability to cope with everyday life. Each item is scored on a scale of 0-10.

Axial involvement

时间窗: 12 weeks

Axial involvement in the patient will be evaluated with the Bath Ankylosing Spondylitis Metrology Index. The Bath AS Metrology Index (BASMI) is a validated composite index of spinal and hip mobility comprising measures of cervical rotation, tragus-to-wall distance, lumbar spinal forward and side flexion, and hip abduction.

Disease activity

时间窗: 12 weeks

The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) will be used to assess disease activity. The index, designed by a multidisciplinary team with input from patients, consists of six 10 cm horizontal visual analog scales to measure severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness (both qualitative and quantitative). The final BASDAI score has a range of 0 to 10.

Sleep Quality

时间窗: 12 weeks

The Pittsburgh Sleep Quality Index will be used to evaluate the sleep quality of patients. The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.

Fatigue

时间窗: 12 weeks

Fatigue Severity Scale (FSS) will be used to evaluate patients' fatigue levels. Fatigue is an overwhelming sense of tiredness and lack of energy that can impair participation in daily tasks and work. It may become a chronic and disabling problem in daily life of the patients with Ankylosing Spondylitis. The FSS is a measurement of fatigue impact on functioning.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gokce Yagmur Gunes Gencer

Associate Professor

Akdeniz University

研究点 (1)

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