Chronic Low-back PainNCT04000685
The Effects of Different Exercise Approaches in Patients With Chronic Low Back Pain
A study testing Yoga exercise program, Spinal stabilization exercise program and Aerobic walking program in people with Chronic Low-back Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Identification of the effects of yoga, stabilization exercise and aerobic exercise approaches on physical and cognitive variables in individuals with low back pain. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Yoga exercise program, Spinal stabilization exercise program and Aerobic walking program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2019to 1 May 2023
- 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Non-specific low back pain
- Must be pain at least 3 months
Who cannot join
- History of any lumbar spine surgery
- Presence of neurological deficit
- Having been diagnosed with cardiovascular or systemic diseases that would prevent him / her from taking exercise training.
- The presence of persistent severe pain
- Pain below the knee
- Severe/progressive scoliosis
Show all 12Show fewer
- Spinal stenosis
- Spondylolisthesis
- Cancer
- Diabetes
- Metabolic syndrome
- Inflammatory, infectious or tumoral disease of the vertebra
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Ankara, Altındag, 06100
About this study
Official title: The Effects of Different Exercise Approaches on Physical and Cognitive Variables in Patients With Chronic Low Back Pain
Identification of the effects of yoga, stabilization exercise and aerobic exercise approaches on physical and cognitive variables in individuals with low back pain.
Read the detailed description
Patients participating in the study were divided three parallel groups. The patients in the stabilization exercise group were instructed to perform spinal stabilization exercises, the patients in the yoga group were instructed to perform yoga program consisting of breathing, relaxation and flexibility exercises. The patients in the aerobic exercise group were instructed to perform aerobic walking training. The severity of the pain evaluated through visual analog scale, functional status and quality of life, alexithymia, kinesiophobia, catastrophic pain, back awareness, cognitive function evaluated through Oswestry Disability Index(ODI), Nottingham Health Profile (NHP), Toronto Alexithymia Scale, Fear Avoidance Beliefs Questionnaire, Pain Catastrophizing Scale, Fremantle Back Awareness Scale, Montreal Cognitive Assessment respectively. Assessments were repeated before and after the treatment.
- Conditions
- Chronic Low-back Pain
- Being tested
- Yoga exercise program, Spinal stabilization exercise program, Aerobic walking program
- Keywords
- low back pain, exercise, cognitive, aerobic, yoga
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga exercise programOther
Yoga exercise program will be applied two sessions per week, totally eight week.
Spinal stabilization exercise programOther
Spinal stabilization exercise program will be applied two sessions per week, totally eight week.
Aerobic walking programOther
Aerobic walking program will be applied two sessions per week, totally eight week.
| Study group | Role | What they receive |
|---|---|---|
| Yoga exercise group | Active comparator | Yoga program were applied all patients in this group accompanied by physiotherapist. Sessions included selected breathing, warm up and relaxation exercises. Receives: Other: Yoga exercise program |
| Spinal stabilization exercise group | Active comparator | Spinal stabilization exercise with three different progressive phases were applied all patients in this group accompanied by physiotherapist. Receives: Other: Spinal stabilization exercise program |
| aerobic walking exercise group | Active comparator | Aerobic walking exercise program applied all patients in this group accompanied by physiotherapist. Receives: Other: Aerobic walking program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain severity
Patients' average resting, activity and night pain intensities assessed by Visual Analog Scale. The visual analog scale is an 11-point scale ranging from 0 to 10, in which 0 defines absence of pain and 10 describes unbearable pain. Participants asked to rate the average pain levels a horizontal 10 cm straight line on a white sheet from, before and after treatment.
Measured: change from baseline in pain severity at 8 weeks
Changes of functional status
Patient's permanent functional disability measured by Oswestry Disability Index. The scale is considered the 'gold standard' of low back functional outcome tools. This scale contain questions related to functional activities of pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling.Interpretation of scale are 0% to 20% for minimal disability, 21% to 40% for moderate disability, 41 % to 60 % for severe disability 61% to 80 % for crippled and 81 % to 100 % Bed-bound.
Measured: change from baseline in functional status at 8 weeks
Secondary outcomes (7)
Changes in quality of life
Health-related quality of life assessed by Nottingham Health Profile (NHP). The NHP contain 38 questions in 6 subareas: pain, physical abilities, energy level, sleep, social isolation and emotional reaction. The scores range from 0 to 100, with each question assigned a weighted value; the sum of all weighted values in a given subarea adds up to 100. Lower scores denoting a better quality of life.
Measured: Change from baseline in life quality levels at 8 weeks
Changes in gait parameters
Gait assessment will be recorded with OptoGait for one minute while participants walked their preferred speed on the treadmill. Patients asked to walk on level surface. Assessment were recorded during one minute.
Measured: Change from baseline in gait parameters at 8 weeks
Changes in metabolic capacity
Metabolic capacity testing will be performed according to the Modified Bruce protocol on the Treadmill. At 3 minute intervals, the inclination increase by %2 with a concomitant increase in speed.
Measured: Change from baseline in metabolic capacity at 8 weeks
Changes in cognitive level
The Montreal Cognitive Assessment Questionnaire (MoCA) will be used to assess the cognitive levels of individuals. MoCA was developed as a rapid screening test for mild cognitive impairment. MoCA assesses various cognitive functions such as attention and concentration, creative functions, memory, language, visual structuring skills, abstract thinking, computation and orientation. The application of MoCA takes about 10 minutes. The maximum total score of the test is 30. A score of 21 or above is considered normal.
Measured: Change from baseline in cognitive level at 8 weeks
Changes in alexithymia
The alexithymia will be assessed by the Toronto Alexithymia Scale (TAS). The scale is a Likert-type self-assessment scale consisting of 20 items and scored between 1-5. Difficulties in recognizing emotions (TAS-1), difficulty in speaking emotions (TAS-2), extroverted thinking (TAS-3) subscales. The individual is asked to select the best option for each item from "Never", "Rarely", "Sometimes", "Often" and "Always". The higher the score, the higher the level of alexithymia.
Measured: Change from baseline in alexithymia at 8 weeks
Changes in kinesiophobia.
Fear-Avoidance-Beliefs Questionnaire will be applied to evaluate kinesiophobia which is fear of movement due to low back pain.This questionnaire has 2 sub-sections related to physical activity and work. There are 4 questions scored in the physical activity section and 7 questions in the work section. 0-6 points are obtained for each question. The total score will be recorded. The higher the score, the higher the kinesiophobia.
Measured: Change from baseline in kinesiophobia at 8 weeks
Changes in back awareness
The Fremantle Back Awareness Questionnaire will be used to evaluate how individuals perceive the back according to their body. The questionnaire includes 9 questions that measure how individuals perceive their back according to their body and how they perceive their body position. Questions is answered Likert type as "0" I never feel like this, "4" always or often feel like this.
Measured: Change from baseline in back awareness at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start30 Dec 2019
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muzeyyen Oz, Hacettepe University
- Investigators
- Müzeyyen ÖZ, MSc, Principal investigator, Hacettepe UniversityÖzlem Ülger, Prof, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000685
- Sponsor's protocol ID
- KA-19029
- Status last verified
- Jun 2023
- First submitted
- 23 Jun 2019
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meng XG, Yue SW. Efficacy of aerobic exercise for treatment of chronic low back pain: a meta-analysis. Am J Phys Med Rehabil. 2015 May;94(5):358-65. doi: 10.1097/PHM.0000000000000188.
PubMed 25299528Inani SB, Selkar SP. Effect of core stabilization exercises versus conventional exercises on pain and functional status in patients with non-specific low back pain: a randomized clinical trial. J Back Musculoskelet Rehabil. 2013;26(1):37-43. doi: 10.3233/BMR-2012-0348.
PubMed 23411647Chang DG, Holt JA, Sklar M, Groessl EJ. Yoga as a treatment for chronic low back pain: A systematic review of the literature. J Orthop Rheumatol. 2016 Jan 1;3(1):1-8.
PubMed 27231715Koldas Dogan S, Sonel Tur B, Kurtais Y, Atay MB. Comparison of three different approaches in the treatment of chronic low back pain. Clin Rheumatol. 2008 Jul;27(7):873-81. doi: 10.1007/s10067-007-0815-7. Epub 2008 Jan 11.
PubMed 18188660Oz M, Ozturk E, Huri G, Ulger O. Comparative biopsychosocial effects of yoga, spinal stabilization, and aerobic exercises in chronic non-specific low back pain: A randomized controlled trial. Physiother Theory Pract. 2026 May 23:1-18. doi: 10.1080/09593985.2026.2676083. Online ahead of print.
PubMed 42175798
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Exercise Approaches on Physical and Cognitive Variables in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04000685
- Acronym / sponsor ID
- KA-19029
- Conditions
- Chronic Low-back Pain
- Keywords
- low back pain, exercise, cognitive, aerobic, yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 27 Jun 2019 (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.
Identification of the effects of yoga, stabilization exercise and aerobic exercise approaches on physical and cognitive variables in individuals with low back pain.
Detailed description
Patients participating in the study were divided three parallel groups. The patients in the stabilization exercise group were instructed to perform spinal stabilization exercises, the patients in the yoga group were instructed to perform yoga program consisting of breathing, relaxation and flexibility exercises. The patients in the aerobic exercise group were instructed to perform aerobic walking training. The severity of the pain evaluated through visual analog scale, functional status and quality of life, alexithymia, kinesiophobia, catastrophic pain, back awareness, cognitive function evaluated through Oswestry Disability Index(ODI), Nottingham Health Profile (NHP), Toronto Alexithymia Scale, Fear Avoidance Beliefs Questionnaire, Pain Catastrophizing Scale, Fremantle Back Awareness Scale, Montreal Cognitive Assessment respectively. Assessments were repeated before and after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Yoga exercise group | Active comparator | Other: Yoga exercise programYoga program were applied all patients in this group accompanied by physiotherapist. Sessions included selected breathing, warm up and relaxation exercises. |
| Spinal stabilization exercise group | Active comparator | Other: Spinal stabilization exercise programSpinal stabilization exercise with three different progressive phases were applied all patients in this group accompanied by physiotherapist. |
| aerobic walking exercise group | Active comparator | Other: Aerobic walking programAerobic walking exercise program applied all patients in this group accompanied by physiotherapist. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Non-specific low back pain
- Must be pain at least 3 months
Key exclusion criteria (12 listed)
- History of any lumbar spine surgery
- Presence of neurological deficit
- Having been diagnosed with cardiovascular or systemic diseases that would prevent him / her from taking exercise training.
- The presence of persistent severe pain
- Pain below the knee
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 |
|---|---|---|
| Yoga exercise programYoga exercise program will be applied two sessions per week, totally eight week. | Other | Yoga exercise group |
| Spinal stabilization exercise programSpinal stabilization exercise program will be applied two sessions per week, totally eight week. | Other | Spinal stabilization exercise group |
| Aerobic walking programAerobic walking program will be applied two sessions per week, totally eight week. | Other | aerobic walking exercise group |
Primary outcome
Changes in pain severity
Time frame: change from baseline in pain severity at 8 weeks
Patients' average resting, activity and night pain intensities assessed by Visual Analog Scale. The visual analog scale is an 11-point scale ranging from 0 to 10, in which 0 defines absence of pain and 10 describes unbearable pain. Participants asked to rate the average pain levels a horizontal 10 cm straight line on a white sheet from, before and after treatment.
Changes of functional status
Time frame: change from baseline in functional status at 8 weeks
Patient's permanent functional disability measured by Oswestry Disability Index. The scale is considered the 'gold standard' of low back functional outcome tools. This scale contain questions related to functional activities of pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling.Interpretation of scale are 0% to 20% for minimal disability, 21% to 40% for moderate disability, 41 % to 60 % for severe disability 61% to 80 % for crippled and 81 % to 100 % Bed-bound.
7 secondary outcomes
Changes in quality of life
Time frame: Change from baseline in life quality levels at 8 weeks
Changes in gait parameters
Time frame: Change from baseline in gait parameters at 8 weeks
Changes in metabolic capacity
Time frame: Change from baseline in metabolic capacity at 8 weeks
Changes in cognitive level
Time frame: Change from baseline in cognitive level at 8 weeks
Changes in alexithymia
Time frame: Change from baseline in alexithymia at 8 weeks
Changes in kinesiophobia.
Time frame: Change from baseline in kinesiophobia at 8 weeks
Changes in back awareness
Time frame: Change from baseline in back awareness at 8 weeks
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 Jun 2023.
- Background: PubMed 25299528Meng XG, Yue SW. Efficacy of aerobic exercise for treatment of chronic low back pain: a meta-analysis. Am J Phys Med Rehabil. 2015 May;94(5):358-65. doi: 10.1097/PHM.0000000000000188.
- Background: PubMed 23411647Inani SB, Selkar SP. Effect of core stabilization exercises versus conventional exercises on pain and functional status in patients with non-specific low back pain: a randomized clinical trial. J Back Musculoskelet Rehabil. 2013;26(1):37-43. doi: 10.3233/BMR-2012-0348.
- Background: PubMed 27231715Chang DG, Holt JA, Sklar M, Groessl EJ. Yoga as a treatment for chronic low back pain: A systematic review of the literature. J Orthop Rheumatol. 2016 Jan 1;3(1):1-8.
- Background: PubMed 18188660Koldas Dogan S, Sonel Tur B, Kurtais Y, Atay MB. Comparison of three different approaches in the treatment of chronic low back pain. Clin Rheumatol. 2008 Jul;27(7):873-81. doi: 10.1007/s10067-007-0815-7. Epub 2008 Jan 11.
- Derived from this study: PubMed 42175798Oz M, Ozturk E, Huri G, Ulger O. Comparative biopsychosocial effects of yoga, spinal stabilization, and aerobic exercises in chronic non-specific low back pain: A randomized controlled trial. Physiother Theory Pract. 2026 May 23:1-18. doi: 10.1080/09593985.2026.2676083. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Chronic Low-back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
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.
Müzeyyen ÖZ, MSc principal investigator
Hacettepe University
Özlem Ülger, Prof study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga exercise program, Spinal stabilization exercise program and Aerobic walking program in people with Chronic Low-back Pain, run by Hacettepe 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 2 inclusion and 12 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 Jun 2023. 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?
Changes in pain severity (time frame: change from baseline in pain severity at 8 weeks). The study lists 2 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 NCT04000685, which also lists 5 linked publications.
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 Jun 2023.