Stretching in Water and on Land for Patients With Ankylosing Spondylitis

Study Overview
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Brief Summary
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The aim of the study is to investigate the effectiveness stretching exercises in ankylosing spondylitis.

Detailed Description
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Ankylosing spondylitis is a chronic, progressive disease with an unknown etiology which characterize with inflammation that leads to bone fusion in spinal joints. Besides the systemic manifestations, chronic pain acquired kyphosis, diminished exercise capacity may cause pulmonary dysfunction, muscle imbalance, reduced quality of life, sleep disruptions and depression. There are strong evidence and advice on exercise should start with diagnosis. Although stretching exercises are the most common exercises in this group the literature on the effectiveness of stretching exercises is scarce. The aim of the study is to investigate the effectiveness stretching exercises in ankylosing spondylitis. The study was carried on patients with ankylosing spondylitis followed by Division of Rheumatology and Immunology, Department of Internal Medicine, Dokuz Eylül University School of Medicine. 57 patients were assessed and randomized into two group control and intervention. Control group informed on the importance of exercise and given a home exercise brochure. The intervention group was also randomized into an aquatic and land stretching group and received stretching exercises two days a week for eight weeks. Two patients from the control group and nine patients (three from aquatic, six from land) from the intervention group were excluded. At the end of eight weeks, except FEV1, FVC, VC all results of the intervention group improved whereas an quality of health was the only result improved in the control group. When aquatic and land stretching groups the results were improved similarly. The improvements of BASFI and MIP of the aquatic group are superior to the land group. Home exercises are playing an important role in the management of ankylosing spondylitis. Addition of stretching exercises to home exercises enhances the effectiveness of the treatment. Aquatic stretching exercises have some benefits than land stretching exercises.

Official Title
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The Effect of Stretching Exercises in Water and on Land on Spinal Mobility and Functional Level in Patients With Ankylosing Spondylitis

Conditions
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Ankylosing Spondylitis

Intervention / Treatment
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* Other: Multidimensional Mobility Exercises
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AS diagnosed according to 1988 Modified New York criteria volunteered with a BASDAI score of 3 or 4 Exclusion Criteria: Patients followed any physical exercise within the last 3 months prior to this study, history of cardiovascular and pulmonary disease were excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aquatic group<br>Aquatic multidimensional mobility exercises were given in the treatment pool at Balcova Thermal Centre, Izmir, Turkey. Group of 6-7 patients was instructed by a specialized physiotherapist twice in a week for eight weeks. The water temperature was 33-340C and the depth was between 110-140 cm, patients were asked to keep T11 level submersion during vertical exercises. Exercise span was kept 30-40 min in first 4 weeks then increased to 45-50 min with additional exercises. | Other: Multidimensional Mobility Exercises<br>* Multidimensional mobility exercises, combined with breathing exercise protocol was established by a committee of specialized physiotherapists and rheumatologist. Land-based and aquatic-based exercises were designed according to environmental features (gravity, buoyancy, viscosity etc).<br>|
| Experimental: Land group<br>Multidimensional mobility exercises were given at exercise unit of Dokuz Eylul University School of Physical Therapy, Izmir, Turkey. Group of 6-7 patients were instructed by a specialized physiotherapist twice in a week for eight weeks. The room temperature was 23-240C. Exercise span was kept 30-40 min in first 4 weeks then increased to 45-50 min with additional exercises. | Other: Multidimensional Mobility Exercises<br>* Multidimensional mobility exercises, combined with breathing exercise protocol was established by a committee of specialized physiotherapists and rheumatologist. Land-based and aquatic-based exercises were designed according to environmental features (gravity, buoyancy, viscosity etc).<br>|
| Active Comparator: Control group<br>A conventional home exercise programme was given by a specialized physiotherapist to control group. Patients were checked and encouraged to continue their programs by weekly phone calls for eight weeks. | Other: Control group<br>* A conventional home exercise programme was given by a specialized physiotherapist to control group. Patients were checked and encouraged to continue their programs by weekly phone calls for eight weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Vital capacity | Vital capacity (VC) (liter) tested with a portable spirometer (MiniSpir, Rome, Italy). The data was given as the (%) percentage of predicted value. | Baseline and 8 weeks | 
| Change in respiratory muscle strength | Strength of diaphragm and other inspiratory muscles was measured with maximal inspiratory pressure (MIP) (cmH2O) while strength of the abdominal muscles and other expiratory muscles was measured with maximal expiratory pressure (MEP) (cmH2O) a digital manometer (Micro RPM, Micro Medical Ltd, Kent, UK) while sitting. The data was given as the percentage (%) of predicted value. | Baseline and 8 weeks | 
| Change in FVC | forced vital capacity (FVC) (liter) tested with a portable spirometer (MiniSpir, Rome, Italy). The data was given as the (%) percentage of predicted value. | Baseline and 8 weeks | 
| Change in FEV1/FVC | forced vital capacity ratio of forced expiratory volume during the first second (FEV1/FVC), tested with a portable spirometer (MiniSpir, Rome, Italy). The data was given as the (%) percentage of predicted value. | Baseline and 8 weeks | 
| Change in PEF | peak expiratory flow (PEF) (liter/sec) tested with a portable spirometer (MiniSpir, Rome, Italy). The data was given as the (%) percentage of predicted value. | Baseline and 8 weeks | 
| Change in MVV | maximum voluntary ventilation (MVV) (liter/min) tested with a portable spirometer (MiniSpir, Rome, Italy). The data was given as the (%) percentage of predicted value. | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functionality | Bath ankylosing spondylitis functional index. Includes 10 questions with 10 cm visual analog scale (VAS) was used to answer the questions. The mean of the ten scales gives the BASFI score - a value between 0 and 10. The higher the BASFI score, the more severe the patient's limitation of function due to their AS | Baseline and 8 weeks | 
| Change in disease activity | Bath Ankylosing Spondylitis Disease Activity Index. BASDAI consists of 10 cm VAS used to answer 6 questions pertaining to the 5 major symptoms of AS: Fatigue; Spinal pain; Joint pain / swelling; Areas of localized tenderness; Morning stiffness. To give each symptom equal weighting, the mean of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 - 10 BASDAI score.The higher the BASDAI score, the more severe the patient's disability due to their AS | Baseline and 8 weeks | 
| Change in spinal mobility | Bath Ankylosing Spondylitis Metrology Index. Tragus to wall distance, Lumbar side flexion, Modified Schober's, Cervical rotation and Intermalleolar distance were inculuded in BASMI. The BASMI was first published in 1994 as a 2-point scale, was adapted a year later into a 10-point scale, and has more recently been proposed and validated as a linear construct. Individual scores are summed for the BASMI2 or averaged for the BASMI10 to give a final score between 0 and 10, where a higher score reflects more significant impairment of spinal mobility. | Baseline and 8 weeks | 
| Change in muscle strength | Upper extremity muscle strength was tested with hand dynamometer while a back and leg dynamometer was used for lower extremities and back muscle strength. Data was given kg. | Baseline and 8 weeks | 
| Change in sleep quality | Pittsburgh sleep quality index. It consists of nineteen questions which finally generate seven component scores: subjective sleep quality,sleep latency, sleep duration, habitual sleep efficiency,sleep disturbances, use of sleep medication and daytimedysfunction. These nineteen items are used for scoring. A total score above 5 is associated with a poor sleep quality | Baseline and 8 weeks | 
| Change in depression | Beck depression scale, a 21-item test presented in multiplechoice format, which purports to measure presence and degree of depression. Responses are made on a four-point, minimally anchored scale, ranging from 0 to 3, with 3 representing the most severe symptoms | Baseline and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aquatherapy, stretching exercises