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Stretching in Water and on Land for Patients With Ankylosing Spondylitis

Primary Purpose

Ankylosing Spondylitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Multidimensional Mobility Exercises
Control group
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring aquatherapy, stretching exercises

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dokuz Eylul University School of Physical Therapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Aquatic group

Land group

Control group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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
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
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.
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.
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
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

Full Information

First Posted
August 27, 2018
Last Updated
September 11, 2018
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT03667625
Brief Title
Stretching in Water and on Land for Patients With Ankylosing Spondylitis
Official Title
The Effect of Stretching Exercises in Water and on Land on Spinal Mobility and Functional Level in Patients With Ankylosing Spondylitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
September 6, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
aquatherapy, stretching exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aquatic group
Arm Type
Experimental
Arm Description
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.
Arm Title
Land group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Multidimensional Mobility Exercises
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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 Outcome Measure Information:
Title
Change in Vital capacity
Description
Vital capacity (VC) (liter) tested with a portable spirometer (MiniSpir, Rome, Italy). The data was given as the (%) percentage of predicted value.
Time Frame
Baseline and 8 weeks
Title
Change in respiratory muscle strength
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change in FVC
Description
forced vital capacity (FVC) (liter) tested with a portable spirometer (MiniSpir, Rome, Italy). The data was given as the (%) percentage of predicted value.
Time Frame
Baseline and 8 weeks
Title
Change in FEV1/FVC
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change in PEF
Description
peak expiratory flow (PEF) (liter/sec) tested with a portable spirometer (MiniSpir, Rome, Italy). The data was given as the (%) percentage of predicted value.
Time Frame
Baseline and 8 weeks
Title
Change in MVV
Description
maximum voluntary ventilation (MVV) (liter/min) tested with a portable spirometer (MiniSpir, Rome, Italy). The data was given as the (%) percentage of predicted value.
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change in functionality
Description
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
Time Frame
Baseline and 8 weeks
Title
Change in disease activity
Description
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
Time Frame
Baseline and 8 weeks
Title
Change in spinal mobility
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change in muscle strength
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change in sleep quality
Description
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
Time Frame
Baseline and 8 weeks
Title
Change in depression
Description
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
Time Frame
Baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baris GURPINAR, PhD
Organizational Affiliation
Dokuz Eylul University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nursen ILCIN, PhD
Organizational Affiliation
Dokuz Eylul University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sema SAVCI, PhD
Organizational Affiliation
Dokuz Eylul University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nurullah AKKOC
Official's Role
Study Director
Facility Information:
Facility Name
Dokuz Eylul University School of Physical Therapy and Rehabilitation
City
Izmir
ZIP/Postal Code
35330
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34962245
Citation
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.
Results Reference
derived

Learn more about this trial

Stretching in Water and on Land for Patients With Ankylosing Spondylitis

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