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临床试验/NCT03667625
NCT03667625已完成不适用

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

Dokuz Eylul University2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2016年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
2
主要终点
Change in FVC

研究概览

简要总结

The aim of the study is to investigate the effectiveness stretching exercises in ankylosing spondylitis.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • AS diagnosed according to 1988 Modified New York criteria volunteered with a BASDAI score of 3 or 4

排除标准

  • Patients followed any physical exercise within the last 3 months prior to this study, history of cardiovascular and pulmonary disease were excluded.

研究组 & 干预措施

Control group

Active Comparator

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.

干预措施: Control group (Other)

Aquatic group

Experimental

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.

干预措施: Multidimensional Mobility Exercises (Other)

Land group

Experimental

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.

干预措施: Multidimensional Mobility Exercises (Other)

结局指标

主要结局

Change in FVC

时间窗: Baseline and 8 weeks

forced vital capacity (FVC) (liter) tested with a portable spirometer (MiniSpir, Rome, Italy). The data was given as the (%) percentage of predicted value.

Change in FEV1/FVC

时间窗: Baseline and 8 weeks

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.

Change in MVV

时间窗: Baseline and 8 weeks

maximum voluntary ventilation (MVV) (liter/min) tested with a portable spirometer (MiniSpir, Rome, Italy). The data was given as the (%) percentage of predicted value.

Change in Vital capacity

时间窗: Baseline and 8 weeks

Vital capacity (VC) (liter) tested with a portable spirometer (MiniSpir, Rome, Italy). The data was given as the (%) percentage of predicted value.

Change in respiratory muscle strength

时间窗: Baseline and 8 weeks

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.

Change in PEF

时间窗: Baseline and 8 weeks

peak expiratory flow (PEF) (liter/sec) tested with a portable spirometer (MiniSpir, Rome, Italy). The data was given as the (%) percentage of predicted value.

次要结局

  • Change in functionality(Baseline and 8 weeks)
  • Change in disease activity(Baseline and 8 weeks)
  • Change in spinal mobility(Baseline and 8 weeks)
  • Change in muscle strength(Baseline and 8 weeks)
  • Change in depression(Baseline and 8 weeks)
  • Change in sleep quality(Baseline and 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Barış Gürpınar

Research Assistant

Dokuz Eylul University

研究点 (2)

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