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

NCT05771376 | Completed

• 1 other identifier: Qigong Exercise in AS
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ankylosing Spondylitis

Keywords

Qigong Exercises; Ankylosing Spondylitis; Pain; Quality of Life; Fatigue

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients who performed the Qigong exercise program

Other: Qigong exercise program

Control Group

EXPERIMENTAL

Patients who performed a home exercise program

Other: Home exercise program

Interventions

Qigong exercise program OTHER

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.

Intervention Group

Home exercise program OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with ankylosing spondylitis diagnosis

You may not qualify if:

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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing; Pain; Fatigue

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gokce Yagmur Gunes Gencer

  Akdeniz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: March 16, 2023
• Study Start: February 13, 2022
• Primary Completion: January 7, 2023
• Study Completion: April 7, 2023
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)