NCT03667625

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2016

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
Last Updated

September 12, 2018

Status Verified

September 1, 2018

Enrollment Period

5 months

First QC Date

August 27, 2018

Last Update Submit

September 11, 2018

Conditions

Ankylosing Spondylitis

Keywords

aquatherapystretching exercises

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (6)

  • 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 sleep quality

    Baseline and 8 weeks

  • +1 more secondary outcomes

Study Arms (3)

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.

Other: Multidimensional Mobility Exercises

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.

Other: Multidimensional Mobility Exercises

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.

Other: Control group

Interventions

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).

Aquatic groupLand group
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

Control group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University School of Physical Therapy and Rehabilitation

Izmir, 35330, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 34962245DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Baris GURPINAR, PhD

    Dokuz Eylul University

    PRINCIPAL INVESTIGATOR

  • Nursen ILCIN, PhD

    Dokuz Eylul University

    STUDY CHAIR

  • Sema SAVCI, PhD

    Dokuz Eylul University

    STUDY DIRECTOR

  • Nurullah AKKOC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

August 27, 2018

First Posted

September 12, 2018

Study Start

February 1, 2016

Primary Completion

July 1, 2016

Study Completion

September 6, 2016

Last Updated

September 12, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)