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Completed

NCT Number: NCT03667625

Stretching in Water and on Land for Patients With Ankylosing Spondylitis

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

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylul University School of Physical Therapy and Rehabilitation

Izmir, 35330, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multidimensional Mobility Exercises

Other

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).

Control Group

Other

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

Primary outcomes

  1. Change in Vital capacity

    Time frame: 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.

  2. Change in respiratory muscle strength

    Time frame: 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.

  3. Change in FVC

    Time frame: 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.

  4. Change in FEV1/FVC

    Time frame: 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.

  5. Change in PEF

    Time frame: 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.

  6. Change in MVV

    Time frame: 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.

Secondary outcomes

  1. Change in functionality

    Time frame: Baseline and 8 weeks

    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

  2. Change in disease activity

    Time frame: Baseline and 8 weeks

    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

  3. Change in spinal mobility

    Time frame: Baseline and 8 weeks

    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.

  4. Change in muscle strength

    Time frame: Baseline and 8 weeks

    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.

  5. Change in sleep quality

    Time frame: Baseline and 8 weeks

    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

  6. Change in depression

    Time frame: Baseline and 8 weeks

    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

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 12, 2018
Registry last updated
Sep 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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