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

Primary Purpose

Ankylosing Spondylitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Qigong exercise program
Home exercise program
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ankylosing Spondylitis focused on measuring Qigong Exercises, Ankylosing Spondylitis, Pain, Quality of Life, Fatigue

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients with ankylosing spondylitis diagnosis Exclusion Criteria: Patients with another rheumatological diseases or orthopedic, neurological, psychiatric, cardiovascular, oncological comorbidities

Sites / Locations

  • Akdeniz University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention Group

Control Group

Arm Description

Patients who performed the Qigong exercise program

Patients who performed a home exercise program

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 5, 2023
Last Updated
April 27, 2023
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT05771376
Brief Title
The Effects of Baduanjin Qigong Exercise on Ankylosing Spondylitis: A Randomized Controlled Study
Official Title
The Effects of Baduanjin Qigong Exercise Via Telerehabilitation in Ankylosing Spondylitis: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 13, 2022 (Actual)
Primary Completion Date
January 7, 2023 (Actual)
Study Completion Date
April 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
Qigong Exercises, Ankylosing Spondylitis, Pain, Quality of Life, Fatigue

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Patients who performed the Qigong exercise program
Arm Title
Control Group
Arm Type
Experimental
Arm Description
Patients who performed a home exercise program
Intervention Type
Other
Intervention Name(s)
Qigong exercise program
Intervention Description
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 Type
Other
Intervention Name(s)
Home exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease activity
Description
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.
Time Frame
12 weeks
Title
Functional capacity
Description
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.
Time Frame
12 weeks
Title
Axial involvement
Description
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.
Time Frame
12 weeks
Title
Sleep Quality
Description
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.
Time Frame
12 weeks
Title
Fatigue
Description
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.
Time Frame
12 weeks
Title
Chest expansion
Description
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.
Time Frame
12 weeks
Title
Ankylosing Spondylitis Quality of Life
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with ankylosing spondylitis diagnosis Exclusion Criteria: Patients with another rheumatological diseases or orthopedic, neurological, psychiatric, cardiovascular, oncological comorbidities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gokce Yagmur Gunes Gencer
Organizational Affiliation
Akdeniz University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akdeniz University
City
Antalya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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