Low Back PainNCT06946758
The Effects of Aerobic Exercise Combined With Core Stabilisation Training on Functional Capacity, Physical Performance and Fall Risk in Geriatric Individuals With Chronic Non-specific Low Back Pain
A study testing Core stabilization exercises and Aerobic Exercises in people with Low Back Pain, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to evaluate the effects of aerobic exercise combined with core stabilisation training (CSE) in elderly individuals with chronic non-specific low back pain (CNSBP). The effects on functional capacity, quality of life, fall risk, functional status and physical performance will be investigated. Read more about this study
- Who is it for?
- Ages 65 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Core stabilization exercises and Aerobic Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 1 Feb 2025
- 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 65 to 84 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients with complaints of low back pain for more than 3 months
- Patients aged between 65-84 years
- Patients with a mini-mental status test score above 24
Who cannot join
- Those with radicular leg pain, sensory and motor deficits in the lower extremities and low back pain with inflammatory character
- Those with previous spinal surgery, spondylolysis, spondylolisthesis, spinal stenosis, vertebral compression, fracture, previous or ongoing spinal infection in past history and examinations
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to evaluate the effects of aerobic exercise combined with core stabilisation training (CSE) in elderly individuals with chronic non-specific low back pain (CNSBP). The effects on functional capacity, quality of life, fall risk, functional status and physical performance will be investigated. Core stabilisation exercises will be applied to both groups. The aerobic exercise intervention group will receive aerobic exercise in addition to core stabilisation exercises. The evaluations will be performed before and after the treatment and the treatment is planned for 3 days a week for 8 weeks. The 6-minute walk test (6MWT) will be used to assess functional capacity, Visual Analogue Scale will be used to assess pain intensity, Oswestry Scale will be used to assess functional status in terms of low back pain, Biodex balance device will be used to assess fall risk, Beck Depression Scale will be used to assess depression, Tampa Kinesiophobia Scale will be used to assess kinesiophobia.
Read the detailed description
Ageing is associated with a decrease in physiological and functional capacities and quality of life. Guidelines recommend at least 150 minutes of moderate-intensity aerobic activity or 75 minutes of vigorous aerobic activity per week and muscle-strengthening activities at least two days per week. With increasing life expectancy, the risk of major health problems affecting the health and well-being of older adults, such as cardiovascular disease and non-communicable diseases related to inactivity, such as diabetes, cognitive decline and poor mental health, is increasing. Considering the problems accompanying low back pain in elderly individuals, regular aerobic exercise at a moderate pace will have a positive effect on quality of life. Aerobic exercises such as walking and swimming can maintain and improve cardiovascular fitness while providing an effective treatment for various chronic and acute diseases ranging from cardiovascular disease to thrombo-embolic stroke, hypertension, type 2 diabetes mellitus, osteoporosis, obesity, colon cancer, breast cancer, anxiety and depression . Regular light-paced aerobic exercise is a well-established protective factor for the prevention and treatment of non-communicable diseases such as cardiovascular disease, stroke, diabetes, as well as some types of cancer such as breast and colon cancer. In the literature, it has been reported that static stabilisation exercises, dynamic exercises, a general exercise programme including a combination of muscle strength, flexibility and aerobic fitness, progressive aerobic exercise and progressive resistance exercise are effective in chronic nonspecific low back pain and that static stabilisation exercises and dynamic exercises are effective on functional status in addition to pain. Although it is generally reported that aerobic exercise is effective in patients with NSBA, there is no clear information in the literature about which exercise methods are more effective in the treatment of NSBA. In addition, many factors such as compliance of the patient population, education, and social status may affect the type of exercise that can be applied. Therefore, it is important to compare the recommended exercise protocols with various exercise programmes.
In this context, the aim of investigators study was to evaluate the effects of aerobic exercises combined with core exercises on functional status and physical performance in geriatric individuals with chronic non-specific low back pain.
- Conditions
- Low Back Pain
- Being tested
- Core stabilization exercises, Aerobic Exercises
- Keywords
- chronic low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stabilization exercisesOther
Also called Control Group
Patients in the core stabilisation exercise group underwent a total of 24 sessions of core stabilisation exercise programme 3 days a week (with at least 1 day of rest between each session) for a total of 8 weeks. Each exercise session was performed under the supervision of a physician in the Department of Physical Medicine and Rehabilitation, Istanbul University, Istanbul Faculty of Medicine. Each session was arranged as 35-minute programmes with an average of 8-10 patients, 5 minutes of which was warm-up. Before starting the exercise, patients were taught to reduce lumbar lordosis by contracting and drawing in the abdominal muscles and to find a lumbar and pelvic neutral position by moving the pelvis forwards and backwards. In each session, the neutral position was found first and attention was paid to maintain the neutral position throughout the exercise. The exercises consisted of 3 levels. The exercise level was completed gradually
Aerobic ExercisesOther
The aerobic exercise group underwent core stabilisation exercises applied to the control group. After the core stabilisation exercises, aerobic exercise was performed with a stationary bicycle at a speed of 50 rpm for approximately 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | The control group will receive core stabilisation exercises 3 days a week for 8 weeks. Core exercise programme was applied to the patients three days a week for 8 weeks. The programme consisted of two weekly parts, and each part was planned according to the weeks by ordering from easy to difficult. Prior to the core stabilisation exercise programme, low intensity 5-10 min warm-up 30 min core exercises consisting of 3 levels were performed. Exercises progressed from easy to difficult according to the condition of the patients. Receives: Other: Core stabilization exercises |
| Aerobic Exercise Group | Experimental | Core stabilisation exercises applied to the control group were applied to the aerobic exercise group. After the core stabilisation exercises, aerobic exercise was performed with a stationary bicycle at a speed of 50 rpm for approximately 40 minutes. Receives: Other: Aerobic Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity
Visual Analogue Scale (VAS) was used to determine the presence and severity of low back pain in the study participants. GAS is a practical test with high validity and reliability in pain assessment. GAS is an assessment method numbered from 0 to 10, where '0' indicates no pain and '10' indicates the presence of the most severe pain. Participants were asked to mark the degree of pain they had on this scale and recorded.
Measured: 8 week
Disability
Functional status was assessed using the Oswestry Disability Index (ODI). The OSI is a widely used questionnaire for the assessment of functional status in patients with low back pain. It includes subjective assessment. There are items including activities of daily living such as pain intensity, self-care, lifting, walking, sitting, standing, sleeping, social life and travelling information. The items are scored between 0-5. The final score is calculated by taking the patient's score as a percentage of the maximum score. Higher scores indicate an increasing level of disability. Turkish validity and reliability was performed by Yakut et al. in 1998.
Measured: 8 week
Risk of fall
Biodex balance system (Biodex Medical System Inc., NY, USA, Model SW45-30D-E6N, SD 950-304) was used for fall risk assessment. This device creates stability indices by evaluating movements in the overall, anterior-posterior and right-left (medial-lateral) directions. Its validity and reliability have been established in this field. It has static and dynamic modes and 12 mobility levels of the platform (mobility level of the floor). In the limit of stability test, there are 9 balls, 1 in the middle and 8 on the edges, and when these balls light up, the person should move the centre of gravity to the burning ball and keep it there for 0.25 seconds. Each ball flashes once during the test and after the ball on the edge lights up, the ball in the centre lights up again. The aim is to move the centre of gravity in the specified direction. The test was performed three times and the extinguishing time of all balls was recorded by the device.
Measured: 8 week
Secondary outcomes (3)
Cardiopulmonary capacity
The 6-minute walk test is used as a simple measure of aerobic exercise capacity. During this test, you walk at a normal pace for six minutes on a 30-metre long hard surface track, marking the track every 3 metres and placing a cone at the end of the 30-metre track and walking back around it. This test can be used to monitor your response to treatments for heart, lung and other health problems.
Measured: 8 week
Depression
Beck depression scale is a widely used psychological measurement tool to assess depression symptoms. This scale developed by Aaron T. Beck is an important tool used to determine the level of depression of individuals and in treatment processes. Beck depression scale consists of a series of questions including various emotional, cognitive and physical symptoms and the answers to the questions provide information about the severity of depression.
Measured: 8 week
Kinesiophobia
The level of kinesiophobia was evaluated with the 'Tampa Kinesiophobia Scale (TKS)'. The TQS is a 17-question questionnaire developed for musculoskeletal pain, which has been validated and reliable in Turkish. In the scale, a 4-point Likert scoring system (1=Strongly disagree, 2=Agree, 3=Disagree, 4=Strongly agree) is used for each question. As a result of the questionnaire, the person receives a total score between 17-68 according to the answers given. A high score indicates a high level of kinesiophobia.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 Jul 2024
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- 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
- randomized controlled trials
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet CANLI, Kirsehir Ahi Evran Universitesi
- Investigators
- Mehmet CANLI, PhD., Principal investigator, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946758
- Sponsor's protocol ID
- 43834581758?
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Consider briefly explaining why IPD will not or might not be shared.
Publications
Kuzu S, Canli M, Valamur I, Ozudogru A, Alkan H, Hartavi A. Effects of aerobic exercise in addition to core stabilization exercises on functional capacity, physical performance and fall risk in geriatric individuals with chronic non-specific low back pain. BMC Sports Sci Med Rehabil. 2025 Jul 29;17(1):218. doi: 10.1186/s13102-025-01271-7.
PubMed 40734175
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Aerobic Exercise Combined With Core Stabilisation Training on Functional Capacity, Physical Performance and Fall Risk in Geriatric Individuals With Chronic Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT06946758
- Acronym / sponsor ID
- 43834581758?
- Conditions
- Low Back Pain
- Keywords
- chronic low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 27 Apr 2025 (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 aim of the study is to evaluate the effects of aerobic exercise combined with core stabilisation training (CSE) in elderly individuals with chronic non-specific low back pain (CNSBP). The effects on functional capacity, quality of life, fall risk, functional status and physical performance will be investigated. Core stabilisation exercises will be applied to both groups. The aerobic exercise intervention group will receive aerobic exercise in addition to core stabilisation exercises. The evaluations will be performed before and after the treatment and the treatment is planned for 3 days a week for 8 weeks. The 6-minute walk test (6MWT) will be used to assess functional capacity, Visual Analogue Scale will be used to assess pain intensity, Oswestry Scale will be used to assess functional status in terms of low back pain, Biodex balance device will be used to assess fall risk, Beck Depression Scale will be used to assess depression, Tampa Kinesiophobia Scale will be used to assess kinesiophobia.
Detailed description
Ageing is associated with a decrease in physiological and functional capacities and quality of life. Guidelines recommend at least 150 minutes of moderate-intensity aerobic activity or 75 minutes of vigorous aerobic activity per week and muscle-strengthening activities at least two days per week. With increasing life expectancy, the risk of major health problems affecting the health and well-being of older adults, such as cardiovascular disease and non-communicable diseases related to inactivity, such as diabetes, cognitive decline and poor mental health, is increasing. Considering the problems accompanying low back pain in elderly individuals, regular aerobic exercise at a moderate pace will have a positive effect on quality of life. Aerobic exercises such as walking and swimming can maintain and improve cardiovascular fitness while providing an effective treatment for various chronic and acute diseases ranging from cardiovascular disease to thrombo-embolic stroke, hypertension, type 2 diabetes mellitus, osteoporosis, obesity, colon cancer, breast cancer, anxiety and depression . Regular light-paced aerobic exercise is a well-established protective factor for the prevention and treatment of non-communicable diseases such as cardiovascular disease, stroke, diabetes, as well as some types of cancer such as breast and colon cancer. In the literature, it has been reported that static stabilisation exercises, dynamic exercises, a general exercise programme including a combination of muscle strength, flexibility and aerobic fitness, progressive aerobic exercise and progressive resistance exercise are effective in chronic nonspecific low back pain and that static stabilisation exercises and dynamic exercises are effective on functional status in addition to pain. Although it is generally reported that aerobic exercise is effective in patients with NSBA, there is no clear information in the literature about which exercise methods are more effective in the treatment of NSBA. In addition, many factors such as compliance of the patient population, education, and social status may affect the type of exercise that can be applied. Therefore, it is important to compare the recommended exercise protocols with various exercise programmes.
In this context, the aim of investigators study was to evaluate the effects of aerobic exercises combined with core exercises on functional status and physical performance in geriatric individuals with chronic non-specific low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- randomized controlled trials
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Other: Core stabilization exercisesThe control group will receive core stabilisation exercises 3 days a week for 8 weeks. Core exercise programme was applied to the patients three days a week for 8 weeks. The programme consisted of two weekly parts, and each part was planned according to the weeks by ordering from easy to difficult. Prior to the core stabilisation exercise programme, low intensity 5-10 min warm-up 30 min core exercises consisting of 3 levels were performed. Exercises progressed from easy to difficult according to the condition of the patients. |
| Aerobic Exercise Group | Experimental | Other: Aerobic ExercisesCore stabilisation exercises applied to the control group were applied to the aerobic exercise group. After the core stabilisation exercises, aerobic exercise was performed with a stationary bicycle at a speed of 50 rpm for approximately 40 minutes. |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients with complaints of low back pain for more than 3 months
- Patients aged between 65-84 years
- Patients with a mini-mental status test score above 24
Key exclusion criteria (2 listed)
- Those with radicular leg pain, sensory and motor deficits in the lower extremities and low back pain with inflammatory character
- Those with previous spinal surgery, spondylolysis, spondylolisthesis, spinal stenosis, vertebral compression, fracture, previous or ongoing spinal infection in past history and examinations
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 |
|---|---|---|
| Core stabilization exercisesAlso: Control GroupPatients in the core stabilisation exercise group underwent a total of 24 sessions of core stabilisation exercise programme 3 days a week (with at least 1 day of rest between each session) for a total of 8 weeks. Each exercise session was performed under the supervision of a physician in the Department of Physical Medicine and Rehabilitation, Istanbul University, Istanbul Faculty of Medicine. Each session was arranged as 35-minute programmes with an average of 8-10 patients, 5 minutes of which was warm-up. Before starting the exercise, patients were taught to reduce lumbar lordosis by contracting and drawing in the abdominal muscles and to find a lumbar and pelvic neutral position by moving the pelvis forwards and backwards. In each session, the neutral position was found first and attention was paid to maintain the neutral position throughout the exercise. The exercises consisted of 3 levels. The exercise level was completed gradually | Other | Control Group |
| Aerobic ExercisesThe aerobic exercise group underwent core stabilisation exercises applied to the control group. After the core stabilisation exercises, aerobic exercise was performed with a stationary bicycle at a speed of 50 rpm for approximately 40 minutes. | Other | Aerobic Exercise Group |
Primary outcome
Pain Severity
Time frame: 8 week
Visual Analogue Scale (VAS) was used to determine the presence and severity of low back pain in the study participants. GAS is a practical test with high validity and reliability in pain assessment. GAS is an assessment method numbered from 0 to 10, where '0' indicates no pain and '10' indicates the presence of the most severe pain. Participants were asked to mark the degree of pain they had on this scale and recorded.
Disability
Time frame: 8 week
Functional status was assessed using the Oswestry Disability Index (ODI). The OSI is a widely used questionnaire for the assessment of functional status in patients with low back pain. It includes subjective assessment. There are items including activities of daily living such as pain intensity, self-care, lifting, walking, sitting, standing, sleeping, social life and travelling information. The items are scored between 0-5. The final score is calculated by taking the patient's score as a percentage of the maximum score. Higher scores indicate an increasing level of disability. Turkish validity and reliability was performed by Yakut et al. in 1998.
Risk of fall
Time frame: 8 week
Biodex balance system (Biodex Medical System Inc., NY, USA, Model SW45-30D-E6N, SD 950-304) was used for fall risk assessment. This device creates stability indices by evaluating movements in the overall, anterior-posterior and right-left (medial-lateral) directions. Its validity and reliability have been established in this field. It has static and dynamic modes and 12 mobility levels of the platform (mobility level of the floor). In the limit of stability test, there are 9 balls, 1 in the middle and 8 on the edges, and when these balls light up, the person should move the centre of gravity to the burning ball and keep it there for 0.25 seconds. Each ball flashes once during the test and after the ball on the edge lights up, the ball in the centre lights up again. The aim is to move the centre of gravity in the specified direction. The test was performed three times and the extinguishing time of all balls was recorded by the device.
3 secondary outcomes
Cardiopulmonary capacity
Time frame: 8 week
Depression
Time frame: 8 week
Kinesiophobia
Time frame: 8 week
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 30 Apr 2025.
- Derived from this study: PubMed 40734175Kuzu S, Canli M, Valamur I, Ozudogru A, Alkan H, Hartavi A. Effects of aerobic exercise in addition to core stabilization exercises on functional capacity, physical performance and fall risk in geriatric individuals with chronic non-specific low back pain. BMC Sports Sci Med Rehabil. 2025 Jul 29;17(1):218. doi: 10.1186/s13102-025-01271-7.
- Individual participant dataSharing planned: No. Consider briefly explaining why IPD will not or might not be shared.
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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.
Mehmet CANLI, PhD. principal investigator
Kirsehir Ahi Evran Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core stabilization exercises and Aerobic Exercises in people with Low Back Pain, run by Kirsehir Ahi Evran Universitesi 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 3 inclusion and 2 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 30 Apr 2025. 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?
Pain Severity (time frame: 8 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06946758, which also lists 1 linked publication.
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 30 Apr 2025.