The Effects of Baduanjin Qigong Exercise on Ankylosing Spondylitis: A Randomized Controlled Study

Ankylosing Spondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05771376
• Other study ID #: Qigong Exercise in AS
• Status: Completed
• Phase: N/A
• Start date: February 13, 2022
• Est. completion date: April 7, 2023

Study information

• Verified date: April 2023
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: April 7, 2023
• Est. primary completion date: January 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Patients with ankylosing spondylitis diagnosis

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Other:
• Qigong exercise program
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. qigong exercise program includes: Preparation posture Prop up the sky by two improve trijiao Draw a bow on both sides like shooting a vulture Raise single arm up to regulate spleen Look back to treat five strains and seven impairments Shake the head and wag to expel Heart (Xin)-fire Pull toes with both hands to reinforce the kidney Clench one's fist and glare to increase strength Rise and fall on tiptoe sevan times to treat all diseases Ending posture. Qigong exercises will be performed 45 minutes twice in a week for 12 weeks.
• Home exercise program
The home exercise program will include stretching for cervical, thoracic and lumbar flexibility, shoulder girdle, hamstring and erector spinal muscles, and strengthening exercises for abdominal, back, and proximal muscles. Home exercises will be performed 45 minutes twice in a week for 12 weeks.

Locations

Country	Name	City	State
Turkey	Akdeniz University	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease activity	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.	12 weeks
Primary	Functional capacity	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.	12 weeks
Primary	Axial involvement	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.	12 weeks
Primary	Sleep Quality	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.	12 weeks
Primary	Fatigue	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.	12 weeks
Primary	Chest expansion	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.	12 weeks
Primary	Ankylosing Spondylitis Quality of Life	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.	12 weeks