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Ankylosing SpondylitisNCT03667625

Stretching in Water and on Land for Patients With Ankylosing Spondylitis

A study testing Multidimensional Mobility Exercises in people with Ankylosing Spondylitis, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to investigate the effectiveness stretching exercises in ankylosing spondylitis. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
Multidimensional Mobility Exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteTurkey (Türkiye)
Study dates
Feb 2016to 6 Sep 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Dokuz Eylul University School of Physical Therapy and Rehabilitation

    Izmir, 35330

Other trials in Turkey (Türkiye)

About this study

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

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

Read the detailed description

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.

Being tested
Multidimensional Mobility Exercises, Control group
Keywords
aquatherapy, stretching exercises
Medical subject headings
Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multidimensional Mobility ExercisesOther

    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 groupOther

    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

Study groups in NCT03667625
Study groupRoleWhat they receive
Aquatic groupExperimentalAquatic 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.
Receives: Other: Multidimensional Mobility Exercises
Land groupExperimentalMultidimensional 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.
Receives: Other: Multidimensional Mobility Exercises
Control groupActive comparatorA 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.
Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 8 weeks

  2. 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.

    Measured: Baseline and 8 weeks

  3. 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.

    Measured: Baseline and 8 weeks

  4. 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.

    Measured: Baseline and 8 weeks

  5. 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.

    Measured: Baseline and 8 weeks

  6. 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.

    Measured: Baseline and 8 weeks

Secondary outcomes (6)

  1. 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

    Measured: Baseline and 8 weeks

  2. 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

    Measured: Baseline and 8 weeks

  3. 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.

    Measured: Baseline and 8 weeks

  4. 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.

    Measured: Baseline and 8 weeks

  5. 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

    Measured: Baseline and 8 weeks

  6. 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

    Measured: Baseline and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2018
  2. Study startFeb 2016
  3. Primary completionJul 2016
  4. Study completion6 Sep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03667625
Sponsor's protocol ID
DorkuzEU
Status last verified
Sep 2018
First submitted
27 Aug 2018
Last updated
12 Sep 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gurpinar B, Ilcin N, Savci S, Akkoc N. Do mobility exercises in different environments have different effects in ankylosing spondylitis? Acta Reumatol Port. 2021 Oct-Dec;46(4):297-316.

    PubMed 34962245

Questions about this trial

What is this clinical trial studying?

A study testing Multidimensional Mobility Exercises in people with Ankylosing Spondylitis, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Vital capacity (time frame: Baseline and 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03667625, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.

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