Effects of Tai Chi in Patients With Ankylosing Spondylitis Receiving Anti-tumor Necrosis Factor Alpha Therapy

NCT03807180 | Completed

• 1 other identifier: 60116787-020/55441
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Ankylosing Spondylitis (AS) is a chronic inflammatory rheumatic disease that causes a decrease in physical activity, fatigue, sleep problems and psychological consequences such as depression, anxiety and stress by primarily affecting the sacroiliac joint and spine. The aim of the treatment of AS is to prevent the hardness and flexion deformity associated with the disease; to maintain the patient's healthy psychological and physical condition. The first step in the treatment of AS; Pharmacological treatment of NSAIDs or Anti-TNFs along with exercise. Exercise, especially pain and immobility symptoms control provides patients with disease is an advantage. Tai Chi Chuan or Taiji is a traditional Chinese exercise method that has been applied for more than 300 years. Exercises based on Chinese medicine and martial arts. It is a combination of physical exercise and relaxation techniques and is used to improve the mental and physical health of individuals. In literature, balance, strength, coordination, postural control, agility, reaction time, flexibility has attracted attention for developing such factors. In addition, it increases muscle strength in elderly people and decreases the risk of falling; Rheumatoid arthritis and Osteoarthritis-related symptoms have been reported to improve in a positive way. In the literature, there is only one study examining the efficacy of Tai Chi in AS patients. According to the results of this study, Tai Chi has a positive effect on disease activity and flexibility of patients with AS. Although there is consensus on exercise role in the treatment of AS, when the literature is reviewed, it is seen that the strict and definite guidelines on the type and frequency of exercises are not yet described. There is no defined protocol for which specific exercise is appropriate in AS. The literature considers that more information is needed on the various physical therapy programs related to intensity, frequency and duration to determine the most appropriate activity for the disease. The aim of this study was to investigate the effect of Tai Chi exercises on functionality, disease activity, functional exercise capacity, spinal mobility, lower extremity strength and quality of life in AS patients with biological agents.

Conditions

Spondylitis, Ankylosing

Keywords

Tai Chi; ankylosing spondylitis; functionality

Outcome Measures

Primary Outcomes (3)

• Bath Ankylosing Spondylitis Functional Index (BASFI)

  This self-assessment instrument was designed by a team of medical professionals in conjunction with patients, and consists of 8 specific questions regarding function in AS and 2 questions reflecting the patient's ability to cope with everyday life. Each question is answered on a 10 cm horizontal visual analog scale, the mean of which gives the BASFI score (0-10). Higher scores show poor functionality.

  ten weeks

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  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. Higher scores show poor disease activity.

  ten weeks

• Bath Ankylosing Spondylitis Metrology Index (BASMI)

  İt is for quantify the mobility of the axial skeleton in ankylosing spondylitis (AS) patients and allow objective assessment of clinically significant changes in spinal movement.It is included of clinical measures of cervical rotation, tragus to wall distance, lumbar flexion, lumbar side flexion, and intermalleolar distance.Each item is scored from 0-10 based on individually defined cut points. Ranges are given as cervical rotation (\>85.0° to ≤8.5°), tragus to wall (\<10 cm to ≥38 cm), lumbar flexion (\>7.0 cm to ≤0.7 cm), lumbar side flexion (\>20.0 cm to \<1.2 cm), and intermalleolar distance (≥120 cm to \<30 cm). Higher scores show poor spinal mobility.

  ten weeks

Secondary Outcomes (2)

• Ankylosing Spondylitis Life Quality Questionnaire (ASQol),

  ten weeks

• 6 minute walking test

  ten week

Study Arms (2)

Group of Tai Chi

OTHER

Group of Tai Chi intervention include 18 patients with AS. Tai Chi exercise method, which is composed of combination of physical exercise and relaxation techniques, will be applied by an experienced physiotherapist who is trained with Tai Chi. The training will take 60 minutes, 2 days a week and 10 weeks in total.

Other: Tai Chi (exercise)

Group of control

NO INTERVENTION

Conventional exercises are stretching for the cervical, thoracic and lumbar flexibility, shoulder circumference, hamstring and erector spinal muscles, strengthening exercises for abdominal, back and proximal muscles. The exercises that will be taught in detail to each stage of the patient will be performed at home by the patient for 60 minutes, 2 days a week. The patients will be inspected and controlled by monthly controls.

Interventions

Tai Chi (exercise) OTHER

Tai Chi exercise method, which is composed of combination of physical exercise and relaxation techniques for patients with rheumatic diseases.

Group of Tai Chi

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being sedentary (not routinely involved in exercise activities during the last 3 months).
• We have been using fixed dose medication for at least 6 months (no change in drug treatment during the study).
• No communication problem

You may not qualify if:

• Functional disorders more effective than ankylosing spondylitis;
• Diastolic heart failure
• Renal failure
• Severe asthma knee osteoarthritis
• Metastatic prostate cancer

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Antalya Education and Research Hospital

Antalya, Konyaalti, 07070, Turkey (Türkiye)

Location

Related Publications (1)

• Lee EN, Kim YH, Chung WT, Lee MS. Tai chi for disease activity and flexibility in patients with ankylosing spondylitis--a controlled clinical trial. Evid Based Complement Alternat Med. 2008 Dec;5(4):457-62. doi: 10.1093/ecam/nem048. Epub 2007 Jul 13.

  PMID: 18955296 RESULT

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Tai Ji; Exercise

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ayse Ayan, Dr

  Antalya Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients with Ankylosing spondylitis receiving anti-tnf alpha therapy
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof, PT

Model Details: Randomized controlled

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 16, 2019
• Study Start: January 25, 2019
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)