NCT03211559

Brief Summary

The aim of our study is to investigate the effect of Clinical Pilates Exercises on functional status and quality of life when applied together with aerobic exercise in patients with ankylosing spondylitis (AS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2016

Completed
9 months until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

December 20, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

12 months

First QC Date

October 19, 2016

Last Update Submit

April 9, 2020

Conditions

Keywords

ankylosing spondylitisclinical pilates exerciseaerobic exercisefunctional exercise capacitypulmonary function

Outcome Measures

Primary Outcomes (1)

  • Aerobic capacity will be detected with submaximal exercise testing (modified Bruce protocol).

    This test will be done while patients walking on TechnoGym Excitemed Treadmillde. Heart rate will be followed with polars on the chest. Medigraph V2000 device will be used to detect the oxygen amount consumed by the patient during the protocol.

    Change from Baseline and at the end of 8 weeks

Secondary Outcomes (22)

  • Lateral spinal flexion distance was measured

    At the begining and at the end of 8 weeks.

  • Lumbal flexion distance was measured

    At the begining and at the end of 8 weeks.

  • Tragus to wall distance was measured

    At the begining and at the end of 8 weeks.

  • Intermalleoler distance was measured

    At the begining and at the end of 8 weeks.

  • servical rotation was measured

    At the begining and at the end of 8 weeks.

  • +17 more secondary outcomes

Study Arms (2)

AEROBİC EXERCİSE (walking on treadmill)

ACTIVE COMPARATOR

Patients walked on treadmill for 8 weeks, 3 days in a week,30-40 minutes each.

Other: Exercise

Aerobic Exercise+Clinical Pilates

EXPERIMENTAL

Patients walked on treamill for 8 weeks, 3 days in a week, 30-40 minutes each. Additionally they did clinical pilates exercise for 8 weeks, 3 days in a week.

Other: Exercise

Interventions

clinical pilates on mat

AEROBİC EXERCİSE (walking on treadmill)Aerobic Exercise+Clinical Pilates

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Man and woman diagnosed with ankylosing spondylitis .

You may not qualify if:

  • Any neurological or muscle diseases
  • Inability to continuously attend the exercise program
  • Visual, hearing or mental problems that could prevent communication
  • Using mobility aids
  • Pregnancy
  • Malignity
  • Having a surgery recently
  • Doing exercise regularly in last 3 months.
  • Having a cardiopulmonary problem which is not under control.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranen University

Famagusta, 99450, Cyprus

Location

MeSH Terms

Conditions

Motor ActivitySpondylitis, Ankylosing

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorAxial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Oksuz

    Eastern Mediterranean University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Instructor

Study Record Dates

First Submitted

October 19, 2016

First Posted

July 7, 2017

Study Start

December 20, 2017

Primary Completion

December 1, 2018

Study Completion

December 20, 2018

Last Updated

April 13, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Not ethical

Locations