NCT03352921

Brief Summary

The aim of this study is to compare the effects of clinical pilates exercises and home exercise program on postural disorders, pain intensity, normal range of motion, muscle strength, endurance, muscle shortness, joint position sense and functional status in desk workers with sagittal cervical disorientation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

2 months

First QC Date

November 9, 2017

Last Update Submit

July 25, 2018

Conditions

Keywords

clinical pilatesexerciseSagital Cervical DisorientationDisorientationForward Head Posture

Outcome Measures

Primary Outcomes (1)

  • Postural Disorders

    The evaluation of cervical and upper thoracic posture will be done through the lateral photography. A camera placed on the tripod will be placed 1,5 m away from the patient while standing in a standing position, and the lens of the camera corresponds to the shoulder of the person. Before the patients will be asked to be on their neutral position, they will be asked to move their heads forth and back for the three times and leave their two arms loose next to the body. Angular calculations will be done by attaching reflective markers to their anatomical points of T4 spinosus process, C7 spinosus process, tragus and eye canthus before the photography. Computer program (Markus Bader-MB Software Solutions, triangular screen ruler) will be used for the angular calculations (craniovertebral angle, head tilt angle, cervico-thoracic angle).

    eigth weeks

Secondary Outcomes (7)

  • Cervical Joint Position Sense

    8 weeks

  • Normal Motion of Cervical Joint

    8 weeks

  • Muscle Strength

    8 weeks

  • muscle endurance

    8 weeks

  • Neck pain

    8 weeks

  • +2 more secondary outcomes

Study Arms (2)

clinical pilates exercises

EXPERIMENTAL

The experimental group will receive clinical pilates exercise training in group form for 3 weeks a week for 8 weeks. The training will be done 40-50 minutes per one day. The exercise session will be started with a 10 minute warming program, 30 minutes with the core stabilization training and the clinical pilates exercises with the postural alignment exercises will be applied and the exercise session will be ended with the 10 minutes cooling period.

Other: clinical pilates exercises

Home exercises program

ACTIVE COMPARATOR

For 8 weeks the member in comparison group will be ask to do the exercise program 3 days a week at home. This group will receive a program of stretching, strengthening, and posture exercises. All the exercises in the program will be illustrated on a descriptive form with images. In terms of the follow-up during 8-week duration, the individuals will be called frequently and in the interview by the end of the study.

Other: home exercises program

Interventions

servikal, deep flexor muscles, posture exercsises

Also known as: exercise program
clinical pilates exercises

stretching, strengthening, and posture exercises to reduce functional disability, to relieve the pain and to provide postural straightening.

Also known as: classical exercises
Home exercises program

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Neck pain at least for three months,
  • Anterior head translation of sagittal segmental alignment disorders,
  • Craniovertebral angle as \<50 degree,
  • Desk-work minimum for 3 years,
  • Working with the computer daily at least for 5 hours,
  • Less severe physical activity level according to the International Physical Activity Questionnaire.

You may not qualify if:

  • Taken any physiotherapy program for the last 6 months due to neck or back pain complain,
  • Pain severe 3 cm or less according to the Visual Analog Scale (VAS),
  • Structural scoliosis,
  • Broken neck history
  • Rheumatic disorder that affects the neck,
  • Acute torticollis,
  • Vertebral column surgical history,
  • Spinal cord compression due to tumor or other reasons,
  • Neurological deficit,
  • Temporomandibular joint problem,
  • Taking any kind of pain killers except for basic analgesics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Famagusta, 99450, Cyprus

Location

Related Publications (1)

  • Hurer C, Angin E, Tuzun EH. Effectiveness of clinical Pilates and home exercises in sagittal cervical disorientation: randomized controlled study. J Comp Eff Res. 2021 Apr;10(5):365-380. doi: 10.2217/cer-2020-0186. Epub 2021 Mar 12.

MeSH Terms

Conditions

Motor ActivityConfusion

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

BehaviorNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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
PHYSİOTHERAPİST

Study Record Dates

First Submitted

November 9, 2017

First Posted

November 24, 2017

Study Start

December 1, 2017

Primary Completion

February 1, 2018

Study Completion

June 1, 2018

Last Updated

July 26, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations