NCT06729281

Brief Summary

Healthy young adults who are health care workers at Haydarpasa Numune Training and Research Hospital will be included in the study considering the inclusion and exclusion criteria. Demographic data such as age, gender, height, weight will be recorded. Thoracic kyphosis and lumbar lordosis angles of the participants will be recorded with Goniometer pro application at the beginning. Spinal muscle thickness including the back extensor muscle group will be measured from the thoracic and lumbar regions with ultrasound by a specialist with clinical experience for ultrasound. Measurement will be made at T8 level for thoracic region and L3 level for lumbar region. They will be evaluated with the Nottingham health profile. A total of 78 people will be included in the study and will be randomly divided into two groups as intervention + exercise and exercise only group. Randomization will be done by closed envelope method. Kinesiobanting will be applied to the intervention group for 4 weeks, with the posture correction technique on Mondays, and the kinesiobant application will be applied once a week for 4 sessions in total, to be removed on Friday. Both groups will be given a 40-minute posture exercise program based on clinical experience, to be performed every other day, i.e. 4 times a week for 12 weeks. Patients will be given an exercise follow-up chart and will be called once a week and followed up for 12 weeks. In the intervention group, thoracic kyphosis and lumbar lordosis angle measurements with Goniometer pro application will be examined at 30.minute at baseline, Week 4 and Week 12, while in the exercise only group they will be examined at baseline, Week 4 and Week 12. Ultrasound measurement of spinal muscle thickness will be performed at baseline and at Week 12 in both groups. Nottingham Health Profile will be performed at baseline, Week 4 and Week 12 in both groups. Differences within and between groups will be analyzed statistically.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

March 20, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 11, 2024

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 11, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

November 21, 2024

Last Update Submit

December 8, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Thoracic kyphosis and lumbar lordosis measurements with Goniometer Pro Application

    Thoracic kyphosis and lumbar lordosis angle measurements with Goniometer pro application will be examined at 30 minutes at baseline, Week 4 and Week 12, whereas only in the exercise group will be examined at baseline, Week 4 and Week 12.

    1. month and 3. month

  • Spinal muscle thickness measurements with Ultrasound

    Ultrasound measurement of spinal muscle thickness will be performed with Mindray brand ultrasound in both groups at baseline and at week 12, with measurements indicated in millimetres.

    1. month and 3. month

Secondary Outcomes (1)

  • Nottingham Health Profile

    1.month and 3. month

Study Arms (2)

exercise

NO INTERVENTION

Regular exercise is also among the factors affecting the formation of posture. A regular and systematic exercise program can change the curvatures of the spine in the sagittal plane.

exercise and kinesio taping

OTHER

Regular exercise is also among the factors affecting the formation of posture. A regular and systematic exercise program can change the curvatures of the spine in the sagittal plane. + Kinesiotaping

Device: kinesio tape

Interventions

The application of kinesio tape is a relatively new method, first developed in 1973 by Kenzo Kase in Japan, also known as elastic bandage, which has become popular in the last 10 years following announcements at major events such as the Olympic Games.

exercise and kinesio taping

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Health workers
  • Over 18 and under 40
  • Visual analog scale (VAS) \< 4 for muscle pain
  • Inactive (category 1) and minimally active (category 2) according to the international physical activity survey
  • Healthcare workers without cognitive deficits who can take verbal instructions

You may not qualify if:

  • Diagnosed disc herniation with or without spinal deformity
  • Bone abnormality and peripheral symptoms
  • Infectious or inflammatory arthropathies
  • History of joint replacement surgery,
  • History of spinal surgery
  • Need for assistive devices for ambulation
  • irregular hypertension
  • Uncontrolled diabetes mellitus
  • Presence of neurological disease
  • History of malignancy
  • Uncontrolled cardiopulmonary disease
  • Pregnancy
  • Morbid obesity (Body mass index \> 35)
  • Having fibromyalgia syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haydarpaşa Numune Training and Research Hospital Physical Medicine and Rehabilitation Clinic

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Pai S A, Zhang H, Shewchuk JR, Al Omran B, Street J, Wilson D, Doroudi M, Brown SHM, Oxland TR. Quantitative identification and segmentation repeatability of thoracic spinal muscle morphology. JOR Spine. 2020 Jul 1;3(3):e1103. doi: 10.1002/jsp2.1103. eCollection 2020 Sep.

    PMID: 33015576BACKGROUND

MeSH Terms

Interventions

Athletic Tape

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor academic member

Study Record Dates

First Submitted

November 21, 2024

First Posted

December 11, 2024

Study Start

March 20, 2024

Primary Completion

July 1, 2024

Study Completion

December 31, 2024

Last Updated

December 11, 2024

Record last verified: 2024-11

Locations