Lumbar Disc HerniationNCT05634330
The Effect of Core Stabilization Exercises on Balance and Quality of Life in Chronic Period in Individuals With Lumbar Disc Herniation
A study testing exercise treatment in people with Lumbar Disc Herniation and Balance; Distorted, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
The Effect of Core Stabilization Exercises on Balance and Quality of Life in Chronic Period in Individuals With Lumbar Disc Herniation Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Lumbar Disc Herniation, Balance; Distorted
- What is being tested?
- exercise treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 45 and over with a diagnosis of Lumbar Disc Herniation,
- Not having any communication barriers (sight, hearing, hearing),
- Have not undergone any surgical procedure in the last 6 months,
- Patients who volunteered to participate in the study
Who cannot join
- Those who do not want to participate in the study,
- Individuals whose age is unsuitable,
- Individuals who continue to receive a therapeutic exercise therapy,
- Individuals with a neurological condition that may affect ankle muscle strength and sensation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
As Physiotherapy Office
Gaziantep, Gazi̇antep, 27000
About this study
The Effect of Core Stabilization Exercises on Balance and Quality of Life in Chronic Period in Individuals With Lumbar Disc Herniation
Read the detailed description
This study was carried out to examine the effect of core stabilization exercises on balance and quality of life in the chronic period in individuals with lumbar disc herniation. Forty patients aged 45-65 years who had been diagnosed with lumbar disc herniation at least one year ago were included in the study. By randomization, they were divided into 2 groups of 20 people, each being the treatment and the control group. A self-prepared form for patient demographic information, McGill Pain Scale and Visual Analog Scale(VAS) for pain assessment; Diasu Gait Analysis Device and Berg Balance Scale for static balance assessment; Timed Up and Go Test, Y Balance Diagram, Functional Reach Test to evaluate dynamic balance; Tinetti Fall Efficiency Scale for assessing falls; The Oswestry Disorder Scale and Nottingham Health Profile were used to assess quality of life and functionality; to evaluate proprioceptive sensation, ankle joint position sense was measured in standing, neutral position (0˚) and angular measurement in 10˚ dorsiflexion. After the questionnaires and measurement tools were completed, the patients were included in the program. While the patients in the control group continued their routine lives, the modified pilates exercise program focused on core stabilization was applied to the patients in the treatment group for 8 weeks, 2 days a week for 50 minutes and in 4 groups. After the treatment process was completed, the questionnaires and measurements were repeated.
- Conditions
- Lumbar Disc Herniation, Balance; Distorted
- Being tested
- exercise treatment
- Keywords
- Lumbar Disc Herniation,, Chronic Period, Balance,, Core Stabilization,, Proprioceptive Sense
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise treatmentOther
core stabilization exercise
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | treatment group: core stabilization exercises used to improve balance Receives: Other: exercise treatment |
| control group | No intervention | this group members have continued their normal lives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in static balance on Diasu Gait Analysis Device at Week 8
To evaluate static balance looking at oscillation length in 1 minute Change= (Week 8 score - Baseline score)
Measured: baseline and Week 8
Change from baseline in weight bearing on Diasu Gait Analysis Device at Week 8
To evaluate weight bearing looking at weight percent for each foot Change= (Week 8 score - Baseline score)
Measured: baseline and Week 8
Change from baseline in static and dynamic balance on Berg Balance Test at Week 8
To evaluate static and dynamic balance. It consists of evaluating 14 activities implemented by direct observation of performance. Each item is scored between 0-4. 0 represents the worst and 4 the best. The total highest score is 56. Scores of 45 and below indicate a risk of falling.
Change= (Week 8 score - Baseline score)
Measured: Baseline and Week 8
Change from baseline in dynamic balance and functionality on Timed Up and Go Test at Week 8
To evaluate dynamic balance and functionality. The person is asked to get up from the stool, to walk with a safe and normal walking speed, to turn and to sit on the stool again. The distance between two stools is fixed at 3 meters. The application time is recorded in seconds. A shorter duration indicates better balance and mobility.
Change= (Week 8 score - Baseline score)
Measured: Baseline and Week 8
Change from baseline in dynamic balance and functionality on Y Balance Test at Week 8
To evaluate dynamic balance and functionality. While standing on one foot, he is asked to take steps with the other foot first anteriorly, then posterolaterally, and finally in the posteromedial direction. At this time, care must be taken that the foot on the ground does not rise from the ground and the balance is not disturbed. The test is repeated 3 times in each direction and the average is taken and recorded in cm. The same measurement is applied to the other foot in the same way.
Change= (Week 8 score - Baseline score)
Measured: Baseline and Week 8
Change from baseline in dynamic balance and functionality on Functional Reach Test at Week 8
To evaluate dynamic balance and functionality. The individual is asked to stand upright for the test and to extend the arm to be measured forward. As the starting point, the 3rd fingertip strip is brought to the 0 point on the tape measure. The tape measure is fixed by the physiotherapist and the patient is asked to lie on the tape measure without losing the contact of the feet with the ground. The test is repeated 3 times and the best distance is recorded in cm. The test is repeated 3 times and the best distance is recorded in cm for the right and left measurement.
Change= (Week 8 score - Baseline score)
Measured: Baseline and Week 8
Change from baseline in dynamic balance and for assessing falls on Tinetti Fall Efficiency Scale at Week 8
To evaluate dynamic balance and for assessing falls. It is a questionnaire consisting of 10 questions measuring A score between 1-10 is given. 1 is scored as very safe and 10 is scored as very high fear of falling. The total highest score is recorded as 100.
Change= (Week 8 score - Baseline score)
Measured: Baseline and Week 8
Change from baseline in pain on Mcgill pain Scale at Week 8
To evaluate pain degree. It is a questionnaire that questions the severity of the pain, its location, its first relationship over time, the sensation it creates in people, and whether it is livable pain for individuals.
Change= (Week 8 score - Baseline score)
Measured: Baseline and Week 8
Change from baseline in pain on Visual Analog Scale at Week 8
To evaluate pain degree. A score between 0-10 is given. 0 means no pain and 10 is scored as excruciating pain.
Change= (Week 8 score - Baseline score)
Measured: Baseline and Week 8
Change from baseline in proprioceptive sensation on ankle joint position sense at Week 8
To evaluate proprioceptive sensation, ankle joint position sense was measured in standing, neutral position (0˚) and angular measurement in 10˚ dorsiflexion.
Change= (Week 8 score - Baseline score)
Measured: Baseline and Week 8
Change from baseline in quality of life and functionality on Nottingham Health Profile at Week 8
To assess quality of life and functionality. It is a scale that questions psychological well-being from different aspects such as physical activity, pain, emotional state, sleep, social life, energy. Short answers are given as yes or no. A person can get a maximum of 600 points. An increase in the score obtained means that the level of quality of life decreases.
Change= (Week 8 score - Baseline score)
Measured: Baseline and Week 8
Change from baseline in quality of life and functionality on Oswestry Disorder Scale at Week 8
To assess quality of life and functionality. It is a questionnaire consisting of 10 items. The person can get points between 0-10 from each item. 0 represents the best level and 5 represents the worst level. The total score is a maximum of 100. As the score increases, it is shown that the functionality of the person worsens and the level of disability increases.
Change= (Week 8 score - Baseline score)
Measured: Baseline and Week 8
A self-prepared form
For patient demographic information,
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start15 Jun 2021
- Primary completion15 Apr 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two group. one of group for exercise and the other group is for control
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asiye Uzun, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634330
- Sponsor's protocol ID
- HasanKU AU-001
- Status last verified
- Nov 2022
- First submitted
- 15 Oct 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Core Stabilization Exercises on Balance and Quality of Life in Chronic Period in Individuals With Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT05634330
- Acronym / sponsor ID
- HasanKU AU-001
- Conditions
- Lumbar Disc Herniation, Balance; Distorted
- Keywords
- Lumbar Disc Herniation,, Chronic Period, Balance,, Core Stabilization,, Proprioceptive Sense
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Effect of Core Stabilization Exercises on Balance and Quality of Life in Chronic Period in Individuals With Lumbar Disc Herniation
Detailed description
This study was carried out to examine the effect of core stabilization exercises on balance and quality of life in the chronic period in individuals with lumbar disc herniation. Forty patients aged 45-65 years who had been diagnosed with lumbar disc herniation at least one year ago were included in the study. By randomization, they were divided into 2 groups of 20 people, each being the treatment and the control group. A self-prepared form for patient demographic information, McGill Pain Scale and Visual Analog Scale(VAS) for pain assessment; Diasu Gait Analysis Device and Berg Balance Scale for static balance assessment; Timed Up and Go Test, Y Balance Diagram, Functional Reach Test to evaluate dynamic balance; Tinetti Fall Efficiency Scale for assessing falls; The Oswestry Disorder Scale and Nottingham Health Profile were used to assess quality of life and functionality; to evaluate proprioceptive sensation, ankle joint position sense was measured in standing, neutral position (0˚) and angular measurement in 10˚ dorsiflexion. After the questionnaires and measurement tools were completed, the patients were included in the program. While the patients in the control group continued their routine lives, the modified pilates exercise program focused on core stabilization was applied to the patients in the treatment group for 8 weeks, 2 days a week for 50 minutes and in 4 groups. After the treatment process was completed, the questionnaires and measurements were repeated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two group. one of group for exercise and the other group is for control
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Other: exercise treatmenttreatment group: core stabilization exercises used to improve balance |
| control group | No intervention | –this group members have continued their normal lives |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals aged 45 and over with a diagnosis of Lumbar Disc Herniation,
Key exclusion criteria (4 listed)
- Those who do not want to participate in the study,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise treatmentcore stabilization exercise | Other | treatment group |
Primary outcome
Change from baseline in static balance on Diasu Gait Analysis Device at Week 8
Time frame: baseline and Week 8
To evaluate static balance looking at oscillation length in 1 minute Change= (Week 8 score - Baseline score)
Change from baseline in weight bearing on Diasu Gait Analysis Device at Week 8
Time frame: baseline and Week 8
To evaluate weight bearing looking at weight percent for each foot Change= (Week 8 score - Baseline score)
Change from baseline in static and dynamic balance on Berg Balance Test at Week 8
Time frame: Baseline and Week 8
To evaluate static and dynamic balance. It consists of evaluating 14 activities implemented by direct observation of performance. Each item is scored between 0-4. 0 represents the worst and 4 the best. The total highest score is 56. Scores of 45 and below indicate a risk of falling. Change= (Week 8 score - Baseline score)
Change from baseline in dynamic balance and functionality on Timed Up and Go Test at Week 8
Time frame: Baseline and Week 8
To evaluate dynamic balance and functionality. The person is asked to get up from the stool, to walk with a safe and normal walking speed, to turn and to sit on the stool again. The distance between two stools is fixed at 3 meters. The application time is recorded in seconds. A shorter duration indicates better balance and mobility. Change= (Week 8 score - Baseline score)
Change from baseline in dynamic balance and functionality on Y Balance Test at Week 8
Time frame: Baseline and Week 8
To evaluate dynamic balance and functionality. While standing on one foot, he is asked to take steps with the other foot first anteriorly, then posterolaterally, and finally in the posteromedial direction. At this time, care must be taken that the foot on the ground does not rise from the ground and the balance is not disturbed. The test is repeated 3 times in each direction and the average is taken and recorded in cm. The same measurement is applied to the other foot in the same way. Change= (Week 8 score - Baseline score)
Change from baseline in dynamic balance and functionality on Functional Reach Test at Week 8
Time frame: Baseline and Week 8
To evaluate dynamic balance and functionality. The individual is asked to stand upright for the test and to extend the arm to be measured forward. As the starting point, the 3rd fingertip strip is brought to the 0 point on the tape measure. The tape measure is fixed by the physiotherapist and the patient is asked to lie on the tape measure without losing the contact of the feet with the ground. The test is repeated 3 times and the best distance is recorded in cm. The test is repeated 3 times and the best distance is recorded in cm for the right and left measurement. Change= (Week 8 score - Baseline score)
Change from baseline in dynamic balance and for assessing falls on Tinetti Fall Efficiency Scale at Week 8
Time frame: Baseline and Week 8
To evaluate dynamic balance and for assessing falls. It is a questionnaire consisting of 10 questions measuring A score between 1-10 is given. 1 is scored as very safe and 10 is scored as very high fear of falling. The total highest score is recorded as 100. Change= (Week 8 score - Baseline score)
Change from baseline in pain on Mcgill pain Scale at Week 8
Time frame: Baseline and Week 8
To evaluate pain degree. It is a questionnaire that questions the severity of the pain, its location, its first relationship over time, the sensation it creates in people, and whether it is livable pain for individuals. Change= (Week 8 score - Baseline score)
Change from baseline in pain on Visual Analog Scale at Week 8
Time frame: Baseline and Week 8
To evaluate pain degree. A score between 0-10 is given. 0 means no pain and 10 is scored as excruciating pain. Change= (Week 8 score - Baseline score)
Change from baseline in proprioceptive sensation on ankle joint position sense at Week 8
Time frame: Baseline and Week 8
To evaluate proprioceptive sensation, ankle joint position sense was measured in standing, neutral position (0˚) and angular measurement in 10˚ dorsiflexion. Change= (Week 8 score - Baseline score)
Change from baseline in quality of life and functionality on Nottingham Health Profile at Week 8
Time frame: Baseline and Week 8
To assess quality of life and functionality. It is a scale that questions psychological well-being from different aspects such as physical activity, pain, emotional state, sleep, social life, energy. Short answers are given as yes or no. A person can get a maximum of 600 points. An increase in the score obtained means that the level of quality of life decreases. Change= (Week 8 score - Baseline score)
Change from baseline in quality of life and functionality on Oswestry Disorder Scale at Week 8
Time frame: Baseline and Week 8
To assess quality of life and functionality. It is a questionnaire consisting of 10 items. The person can get points between 0-10 from each item. 0 represents the best level and 5 represents the worst level. The total score is a maximum of 100. As the score increases, it is shown that the functionality of the person worsens and the level of disability increases. Change= (Week 8 score - Baseline score)
A self-prepared form
Time frame: Baseline
For patient demographic information,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise treatment in people with Lumbar Disc Herniation and Balance; Distorted, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in static balance on Diasu Gait Analysis Device at Week 8 (time frame: baseline and Week 8). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.