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

April 27, 2023 updated by: Gokce Yagmur Gunes Gencer, Akdeniz University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey
        • Akdeniz University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with ankylosing spondylitis diagnosis

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Patients who performed the Qigong exercise program
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.
Experimental: Control Group
Patients who performed a home exercise program
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease activity
Time Frame: 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.
12 weeks
Functional capacity
Time Frame: 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.
12 weeks
Axial involvement
Time Frame: 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.
12 weeks
Sleep Quality
Time Frame: 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.
12 weeks
Fatigue
Time Frame: 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.
12 weeks
Chest expansion
Time Frame: 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.
12 weeks
Ankylosing Spondylitis Quality of Life
Time Frame: 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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Investigators

  • Principal Investigator: Gokce Yagmur Gunes Gencer, Akdeniz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2022

Primary Completion (Actual)

January 7, 2023

Study Completion (Actual)

April 7, 2023

Study Registration Dates

First Submitted

March 5, 2023

First Submitted That Met QC Criteria

March 5, 2023

First Posted (Actual)

March 16, 2023

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 27, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Qigong Exercise in AS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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