search
Back to results

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

Primary Purpose

Spondylitis, Ankylosing

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Tai Chi (exercise)
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spondylitis, Ankylosing focused on measuring Tai Chi, ankylosing spondylitis, functionality

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Antalya Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Group of Tai Chi

Group of control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Ankylosing Spondylitis Life Quality Questionnaire (ASQol),
It is purpose to measure the impact of ankylosing spondylitis (AS) on health-related quality of life from the patient's perspective.The questionnaire includes items related to the impact of disease on sleep, mood, motivation, coping, activities of daily living, independence, relationships, and social life. It is included 18 items.Dichotomous responses, with 0 scored for a "no" and 1 scored for a "yes" for each item. Total score is the sum of the individual responses.Score range is 0-18, with higher scores reflecting greater impairment of health-related quality of life.
6 minute walking test
The maximum distance that individuals can walk in a 30-meter straight and inclined corridor for 6 minutes is recorded. Higher distances show better aerobic capacity

Full Information

First Posted
January 10, 2019
Last Updated
January 11, 2020
Sponsor
Pamukkale University
search

1. Study Identification

Unique Protocol Identification Number
NCT03807180
Brief Title
Effects of Tai Chi in Patients With Ankylosing Spondylitis Receiving Anti-tumor Necrosis Factor Alpha Therapy
Official Title
Tai Chi in Patients With Ankylosing Spondylitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 25, 2019 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale 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
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.
Detailed Description
At least 36 AS patients followed-up by Antalya Training and Research Hospital, who are receiving Anti-TNF therapy and who do not have any other disease affecting their functions will be included in the study. There were 18 patients in the conventional treatment group and 18 patients in the Tai Chi group. After the demographic data of AS patients were recorded, Bath AS Disease Activity Index (BASDAI), Bath AS Disease Activity Index (BASFI) and Bath AS Metrology Index (BASMI), respectively, to be used for activity and basic measurements of the disease, 6 minutes walking test to measure aerobic capacity , Cognitive Exercise Therapy Approach Scale and Ankylosing Spondylitis Quality of Life Questionnaire to be used for quality of life, 30 second sit-down test to evaluate the lower extremity strength. In addition, 10-20 ml (1-2 tubes) of blood will be taken from the patient's arm, the amount of substances such as erythrocyte sedimentation rate (ESR) and C reactive protein (CRP) in the blood will be measured. Patients will not be charged any fee related to this process. Evaluation methods will be applied to the cases before the start of training and after the completion of the training. For the training, both patient groups were randomly divided into two groups: the first group was treated with conventional treatment and the second group with Tai Chi training. The training will last 10 weeks. Conventional treatment; 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylitis, Ankylosing
Keywords
Tai Chi, ankylosing spondylitis, functionality

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled
Masking
Participant
Masking Description
Patients with Ankylosing spondylitis receiving anti-tnf alpha therapy
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group of Tai Chi
Arm Type
Other
Arm Description
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.
Arm Title
Group of control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Tai Chi (exercise)
Intervention Description
Tai Chi exercise method, which is composed of combination of physical exercise and relaxation techniques for patients with rheumatic diseases.
Primary Outcome Measure Information:
Title
Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
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.
Time Frame
ten weeks
Title
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Description
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.
Time Frame
ten weeks
Title
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Description
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.
Time Frame
ten weeks
Secondary Outcome Measure Information:
Title
Ankylosing Spondylitis Life Quality Questionnaire (ASQol),
Description
It is purpose to measure the impact of ankylosing spondylitis (AS) on health-related quality of life from the patient's perspective.The questionnaire includes items related to the impact of disease on sleep, mood, motivation, coping, activities of daily living, independence, relationships, and social life. It is included 18 items.Dichotomous responses, with 0 scored for a "no" and 1 scored for a "yes" for each item. Total score is the sum of the individual responses.Score range is 0-18, with higher scores reflecting greater impairment of health-related quality of life.
Time Frame
ten weeks
Title
6 minute walking test
Description
The maximum distance that individuals can walk in a 30-meter straight and inclined corridor for 6 minutes is recorded. Higher distances show better aerobic capacity
Time Frame
ten week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Functional disorders more effective than ankylosing spondylitis; Diastolic heart failure Renal failure Severe asthma knee osteoarthritis Metastatic prostate cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayse Ayan, Dr
Organizational Affiliation
Antalya Education and Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Antalya Education and Research Hospital
City
Antalya
State/Province
Konyaalti
ZIP/Postal Code
07070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will use Statistical package for the social sciences (SPSS) for participant data after interventions
Citations:
PubMed Identifier
18955296
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs