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

Sponsor
Akdeniz University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05771376
Collaborator
(none)
58
1
2
17.7
3.3

Study Details

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. 58 volunteer individuals, ages 18-64, will be included in the study. They will be randomly divided into two groups (the study and the control).

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

Condition or Disease Intervention/Treatment Phase
  • Other: Qigong exercise program
  • Other: Conventional exercise program
N/A

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 study group) and 29 healthy individuals (the control group), totaling 58 volunteer individuals ages 18-64, will be included in the study.

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

Qigong exercises will be performed two days a week for 45 minutes. Home exercises will be performed every day, twice a day, for approximately 30 minutes.

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 Design

Study Type:
Interventional
Anticipated Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effects of Baduanjin Qigong Exercise on Ankylosing Spondylitis: A Randomized Controlled Study
Actual Study Start Date :
Feb 13, 2022
Anticipated Primary Completion Date :
May 7, 2023
Anticipated Study Completion Date :
Aug 7, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study Group

Patients who performed Qigong exercise program and conventional exercise program

Other: Qigong exercise program
The study group will perform a qigong exercise program online (via Zoom video conference) for 12 weeks under the supervision of two physiotherapists, and a conventional exercise program. 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

Other: Conventional 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 every day, twice a day, for approximately 30 minutes.

Experimental: Control Group

Patients who performed a conventional exercise program

Other: Conventional 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 every day, twice a day, for approximately 30 minutes.

Outcome Measures

Primary Outcome Measures

  1. Disease activity [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.

  2. Functional capacity [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.

  3. Axial involvement [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.

  4. Sleep Quality [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.

  5. Fatigue [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.

  6. Chest expansion [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.

  7. Ankylosing Spondylitis Quality of Life [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patients with ankylosing spondylitis diagnosis
Exclusion Criteria:
  • Patients with another rheumatological diseases or orthopedic, neurological, psychiatric, cardiovascular, oncological comorbidities

Contacts and Locations

Locations

Site City State Country Postal Code
1 Akdeniz University Antalya Turkey

Sponsors and Collaborators

  • Akdeniz University

Investigators

  • Principal Investigator: Gokce Yagmur Gunes Gencer, Akdeniz University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gokce Yagmur Gunes Gencer, Associate Professor, Akdeniz University
ClinicalTrials.gov Identifier:
NCT05771376
Other Study ID Numbers:
  • Qigong Exercise in AS
First Posted:
Mar 16, 2023
Last Update Posted:
Mar 16, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gokce Yagmur Gunes Gencer, Associate Professor, Akdeniz University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2023