NCT06540053

Brief Summary

Prolonged periods of desk work and static postures in office workers lead to various musculoskeletal issues in both the lower and upper extremities. One such issue is hamstring muscle tightness observed in individuals. Tight hamstring muscles contribute to increased electromyographic muscle activity in the lumbar region, altered lumbopelvic rhythm, and changes in lumbar stabilization, leading to low back pain. The viscoelastic properties of the hamstring muscles play a crucial role in maintaining posture and stabilizing the lumbar region. Insufficient hamstring flexibility or viscoelastic properties can alter pelvic position and result in excessive stress in the lumbar region, thereby increasing the risk of low back pain. It is anticipated that the activation, stabilization, and viscoelasticity of the muscles in the lumbar region will change through static active hamstring stretching exercises, which aim to restore the length-tension relationship in the hamstring muscles. This study aims to investigate the effect of active static hamstring stretching exercises on lumbar muscle activation, stabilization, and viscoelasticity in office workers.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

August 1, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

September 10, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
Last Updated

September 19, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

August 1, 2024

Last Update Submit

September 11, 2024

Conditions

Keywords

Muscle ActivationElectromyographic Muscle ActivityStabilizationViscoelastic PropertiesHamstring FlexibilityPostureLow back

Outcome Measures

Primary Outcomes (3)

  • Surface Electromyograph

    The electromyographic muscle activity of the rectus abdominis, erector spinae, internal and external oblique muscles will be evaluated. Muscle contraction activations will be measured using a two-channel Delsys Trigno Avanti Wireless surface EMG system (Delsys, Inc., Boston, MA, USA). Surface EMG electrodes will be used with the Trigno Avanti EMG sensor, placed at the motor points of the muscles. EMG data sampling will be conducted at a rate of 1000 Hz, with a bandwidth of 20-400 Hz, common mode rejection ratio greater than 80 dB, and root mean square calculated using EMG Works 4.0 analysis software (Delsys, Boston, MA, USA). Prior to electrode placement, skin will be cleaned according to criteria specified by SENIAM for the non-invasive assessment of muscles using Surface Electromyography.

    6 weeks

  • Stabilizer Pressure Biofeedback Unit

    Participants will be assessed using "The Stabilizer Pressure Biofeedback Unit" (Chattanooga Group, Inc., US). The pressure cell of the device will be positioned under the lumbar vertebrae, aligned with the midpoint of the posterior superior iliac spines (PSIS). After inflating the manometer to 40 mmHg, participants will be instructed to draw their abdominal wall inwardly. Success is defined as maintaining 40 mmHg pressure without any compensation. Participants will then lie prone, with the pressure cell positioned under the lower abdominal region, aligned with the midpoint of the anterior superior iliac spines (ASIS). After setting the manometer's pressure to 70 mmHg, participants will be asked to contract their muscles. A successful test requires a pressure decrease of 6-10 mmHg. A decrease of less than 2 mmHg, no change, or an increase in pressure indicates muscle inadequacy.

    6 weeks

  • Myoton

    To measure the viscoelastic properties of the rectus abdominis, erector spinae, internal, and external oblique muscles, the MyotonPRO (Muomeetria Ltd., Tallinn, Estonia) will be used. Participants will lie comfortably in a prone position. The device probe (3mm diameter, polycarbonate) will be positioned perpendicular to the skin projection of the muscle being measured. A fixed pre-load of 0.18 N will be applied to compress the superficial tissues of the skin. Beneath the compressed subcutaneous tissues, a fixed mechanical force of 0.4 N will apply rapid impulses (15ms) by the device. These mechanical impulses induce local and elastic deformation in the measured muscle. After this deformation, the muscle responds with natural damped oscillations as it returns to its initial state, and these oscillations are recorded as an acceleration graph by sensitive accelerometers at the other end of the probe, which operate frictionlessly and precisely.

    6 weeks

Secondary Outcomes (3)

  • Myoton

    6 weeks

  • Sit and Reach Test

    6 weeks

  • PostureScreen Mobile® App

    6 weeks

Study Arms (2)

Study Group

EXPERIMENTAL

Active Static Hamstring Stretching Participants will perform 10-minute active static hamstring exercises for 5 days a week over a period of 6 weeks.

Other: Active Static Hamstring Stretch Exercise

Control Group

OTHER

Participants will receive training on spinal protection principles within the office setting and will be sent short messages containing information on maintaining proper posture throughout the day on their phones for a period of 6 weeks.

Other: Waiting List

Interventions

In the first session, participants will be instructed on the principles of spinal protection. Following this, members of the experimental group will engage in active hamstring exercises within the office environment. These exercises will be conducted for 10 minutes, consisting of 10 repetitions of 30-40 seconds of stretching followed by 30 seconds of rest, five days a week for six weeks. Participants in the experimental group will be remotely supervised during the stretching exercises.

Study Group

Participants will receive workplace training on spine protection principles and subsequently be placed on a waiting list. Throughout this process, individuals in the designated group will receive text messages on Mondays, Wednesdays, and Fridays over the course of six weeks. These messages will contain information aimed at assisting them in maintaining correct posture throughout the workday.

Control Group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals aged between 20 and 50 years
  • Who are office workers
  • Spending at least 5 hours daily sitting at a desk
  • Willing to participate in the study
  • And classified as physically inactive according to the International Physical Activity Short Form

You may not qualify if:

  • Individuals with a history of lumbar spine and knee surgery within the last 6 months
  • A history of any hamstring muscle injury within the last 6 months
  • Presence of osteoporosis
  • Concurrent mental, metabolic, rheumatologic, neuromuscular, cardiovascular, or pulmonary conditions
  • Currently pregnant
  • And individuals classified as obese (BMI \> 30 kg/m²)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Waiting Lists

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Ayse Zengin Alpözgen, Assoc. Prof.

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayse Zengin Alpozgen, Assoc. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

August 1, 2024

First Posted

August 6, 2024

Study Start

September 10, 2024

Primary Completion

December 25, 2024

Study Completion

January 10, 2025

Last Updated

September 19, 2024

Record last verified: 2024-08

Locations