NCT02869373

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

April 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
Last Updated

August 16, 2016

Status Verified

August 1, 2016

Enrollment Period

3 months

First QC Date

August 12, 2016

Last Update Submit

August 12, 2016

Conditions

Hypermobility Syndrome

Outcome Measures

Primary Outcomes (1)

  • Change in musculoskeletal pain intensity as measured by Visual Analog Scale

    Change from baseline musculoskeletal pain intensity at 8 weeks

Secondary Outcomes (2)

  • Change in trunk muscle endurance as measued with McGill's trunk muscle endurance tests

    Change from baseline trunk muscle endurance at 8 weeks

  • Change in postural stability as measured with Biodex Balance System SD

    Change from baseline postural stability at 8 weeks

Study Arms (2)

Exercise

EXPERIMENTAL

spinal stabilization exercise program was applied

Behavioral: spinal stabilizaton exercise

Control

NO INTERVENTION

Interventions

spinal stabilizaton exerciseBEHAVIORAL

In Exercise group, spinal stabilization exercise program was carried out 3 days a week for 8 weeks.

Exercise

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Seyda TOPRAK CELENAY

    Ankara Yildirim Beyazıt University

    STUDY DIRECTOR

  • Derya OZER KAYA

    Izmir Katip Celebi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 12, 2016

First Posted

August 16, 2016

Study Start

April 1, 2015

Primary Completion

July 1, 2015

Study Completion

October 1, 2015

Last Updated

August 16, 2016

Record last verified: 2016-08