Spinal Stabilization Exercise Effects in Hypermobility

August 12, 2016 updated by: Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital

Assistant Professor

The aim of this study is to investigate the effects of an 8-week lumbar spinal stabilization exercise program on pain, trunk muscle endurance and postural stability in women with benign joint hypermobility syndrome

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • volunteers in an age range of 18 to 30,
  • being women,
  • having benign joint hypermobility syndrome diagnosed according to the Brighton criteria,
  • having no contraindication to join an exercise program.

Exclusion Criteria:

  • having rheumatologic or neurologic diseases,
  • any other pathology involving the musculoskeletal system-history of fractures, joint dislocations, sprains and strains,
  • associated connective tissue disorders including Marfan syndrome, Ehlers-Danlos syndrome, osteogenesis imperfecta,
  • severe psychological disorders,
  • being pregnant,
  • intervention including exercise or physical therapy in the last 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Exercise
spinal stabilization exercise program was applied
In Exercise group, spinal stabilization exercise program was carried out 3 days a week for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in musculoskeletal pain intensity as measured by Visual Analog Scale
Time Frame: Change from baseline musculoskeletal pain intensity at 8 weeks
Change from baseline musculoskeletal pain intensity at 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in trunk muscle endurance as measued with McGill's trunk muscle endurance tests
Time Frame: Change from baseline trunk muscle endurance at 8 weeks
Change from baseline trunk muscle endurance at 8 weeks
Change in postural stability as measured with Biodex Balance System SD
Time Frame: Change from baseline postural stability at 8 weeks
Change from baseline postural stability at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Seyda TOPRAK CELENAY, Yildirim Beyazit University
  • Principal Investigator: Derya Ozer Kaya, Izmir Katip Celebi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

August 12, 2016

First Submitted That Met QC Criteria

August 12, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Estimate)

August 16, 2016

Last Update Submitted That Met QC Criteria

August 12, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 2015-64/82

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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