Chronic Low-back PainNCT07910669
The Effectiveness of Pilates Exercise on Chronic Low Back Pain of The Older Adults
A study testing Pilates exercise in people with Chronic Low-back Pain, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
Background: Low-back pain is one of the most common health conditions worldwide. It is defined as pain below the costal margin and above the inferior gluteal folds. Due to aging, older adults experience pain, which can threaten their safety, autonomy, and independence, limit their social interactions, and reduce their… Read more about this study
- Who is it for?
- Ages 40 to 69 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Pilates exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2025to 1 Feb 2026
- 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 40 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Middle-aged and older adults aged 40-69 years.
- Chief complaint of recurrent low back pain located below the costal margin and above the gluteal folds, persisting for more than 3 months (12 weeks) without evidence of structural damage.
- Visual Analogue Scale (VAS) score for pain intensity greater than 30 mm within the past 7 days.
- Chinese version of the Oswestry Disability Index (ODI) score greater than 11 points.
- Diagnosis of chronic low back pain (CLBP) confirmed by a physician or a licensed physical therapist with at least 2 years of clinical experience.
Who cannot join
- Exclusion criteria will consider both current and past conditions. Participants will be excluded if any of the following apply:
- Contraindications, including:Electrocardiographic changes or history of myocardial infarction、Unstable angina、Uncontrolled cardiac arrhythmias、Aortic stenosis、Uncontrolled heart failure、Acute pulmonary embolism or pulmonary infarction、Acute myocarditis or pericarditis、Suspected or confirmed aortic dissection、Acute systemic infection with fever, generalized pain, or lymphadenopathy
- Presence of severe spinal disorders, such as:Fracture
- 、Tumor、.Inflammatory disease、Ankylosing spondylitis、Radiculopathy confirmed by neurological examination
- History of or scheduled for spinal surgery.
- Inability to walk independently (requiring walking aids or assistance from others).
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- Engagement in regular physical activity, defined as ≥3 sessions per week of leisure-time exercise lasting ≥30 minutes each, within the past 2 weeks.
- Diagnosis of cognitive impairment.
- Presence of neurological or neuromuscular disorders affecting motor function, including:Multiple sclerosis、Parkinson's disease、Amyotrophic lateral sclerosis (ALS)、Stroke
Trial locations and contacts
1 site in 1 country.
About this study
Background: Low-back pain is one of the most common health conditions worldwide. It is defined as pain below the costal margin and above the inferior gluteal folds. Due to aging, older adults experience pain, which can threaten their safety, autonomy, and independence, limit their social interactions, and reduce their quality of life. In exercise therapy, Pilates is considered effective for strengthening core muscles, improving muscle endurance, enhancing spinal control, and promoting trunk stability, thereby minimizing joint load. However, current research has focused on younger populations and lacks detailed descriptions of exercise interventions, making it unclear whether Pilates core exercises would benefit middle-aged and older adults.Therefore, this study incorporates resistance bands and yoga blocks into a Pilates regimen, emphasizing hip mobility exercises and gluteus medius strengthening to enhance the effectiveness of Pilates in treating chronic low back pain. This study aims to design a Pilates exercise therapy program for CLBP that includes hip mobility improvement and gluteus medius training to improve pain, disability level, hip mobility, gluteus medius strength, gluteal endurance, emotional function, participants' ratings of improvement and satisfaction, and participants' intention toward treatment.Purpose: This study targets individuals aged 40 to 69 with chronic low back pain and aims to:Develop an 8-week Pilates core exercise program focusing on gluteal strengthening and increased hip mobility, conducted three times per week for 60 minutes per session, to assess the effectiveness of primary outcome variables (pain, disability) and secondary outcome variables (emotional function, gluteus medius strength, gluteal endurance, hip mobility, satisfaction, self-efficacy).Methods: A single-blind randomized group design will be used in this study. Participants must be aged between 40 and 69 and have had low back pain for more than three months. They will be randomly assigned to either a control group or a Pilates intervention group.Outcome measurement:Outcome measurements include the Visual Analogue Scale (VAS) for pain, the Oswestry Disability Index (ODI), the Beck Depression Inventory (BDI), gluteus medius strength measured by microFET3, hip mobility, self-efficacy for exercise (SEE-C), and the Patient Global Impression of Change (PGIC) scale.
- Conditions
- Chronic Low-back Pain
- Being tested
- Pilates exercise
- Keywords
- chronic low back pain, low back pain, Pilates, middle-aged and elderly adults, hip mobility, gluteus medius, exercise, Pilates exercise
- 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.
Pilates exerciseBehavioural
Develop an 8-week Pilates core exercise program focusing on gluteal strengthening and increased hip mobility, conducted three times per week for 60 minutes per session.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 8-week Pilates core exercise program focusing on gluteal strengthening and increased hip mobility, conducted three times per week for 60 minutes per session. Receives: Behavioral: Pilates exercise |
| Control group | No intervention | Participants in the control group will maintain their normal activities of daily living without any experimental intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain was measured using a visual analogue scale (VAS).
The visual analogue scale consists of a 10-cm line, each labelled at the left end as 'no pain' (0) and at the right end as 'very severe pain' (10).Patients were asked to draw a vertical mark on each line(Delgado et al., 2018).
Measured: A total of three measurements were taken (one baseline and two post-tests at 4 and 8 weeks post-intervention).
Disability was assessed using the Oswestry Disability Index (ODI).
Disability was assessed using the Oswestry Disability Index. It contains ten items related to limitations in daily life activities, rating each on a 0-5 point scale; the points are added together and converted into a percentage:Minimally disabled (0-10%), moderately disabled(20-40%), severely disabled (40-60%), crippled (60-80%) or bedbound (80-100%)(Rocchi et al., 2005).
Measured: A total of three measurements were taken (one baseline and two post-tests at 4 and 8 weeks post-intervention).
Secondary outcomes (5)
The Beck Depression Scale was used to measure the severity of depressive symptoms among patients(Dworkin et al., 2008).
The BDI consists of 21 groups of four statements designed to assess the severity of current depressive symptoms, with a total score ranging from 0 to 63. Beck and Steer suggested that scores below 10 should be considered to reflect "mild or none" depression, 10 to 18, 19 to 29, and 30 to 63 to reflect "mild to moderate," "moderate to severe," and "severe" depression, respectively (Beck et al., 1988).
Measured: A total of three measurements were taken (one baseline and two post-tests at 4 and 8 weeks post-intervention).
Muscle power measured by microFET3.
Muscle power measured by microFET3. Patient Position: Lying on their side with the test leg up. At the start of the test, the limb is slightly extended beyond the midline, and the pelvis is slightly rotated forward. The lower leg is bent for stability.
Therapist Position: Standing behind the patient. The hand applying resistance is placed on the lateral side near the ankle. The hand used to palpate the gluteus medius is placed proximal to the greater trochanter of the femur.
Instructions to the Patient:
"Lift your leg. Hold it. Don't let me press it down."
Measured: A total of three measurements were taken (one baseline and two post-tests at 4 and 8 weeks post-intervention).
Hip mobility measured using a GEMRED brand, model: 82311-300 electronic protractor.
The range of free movement a joint can make during body movement. It is the number of arc degrees of movement between the start and end of a movement on a specific plane.
Measured: A total of three measurements were taken (one baseline and two post-tests at 4 and 8 weeks post-intervention).
The Chinese version of the self-efficacy for exercise (SEE-C) scale
The Chinese version of the self-efficacy for exercise (SEE-C) scale was designed to test people's confidence to continue exercising in the face of barriers to exercise (Lee et al., 2009).It attempts to predict and explain human behavior by referencing an individual's assessment of their ability or effectiveness in successfully performing a specific behavior. Self-efficacy theory suggests that the stronger an individual's self-efficacy and outcome expectations, the more likely they are to initiate and persist in a specific activity. Self-efficacy theory includes self-efficacy expectations, which are an individual's beliefs about their ability to perform a series of actions to achieve a desired outcome, and the belief that their actions will produce a certain result.
Measured: A total of two measurements were taken ( baseline and 8 weeks post-intervention).
Patient Global Impression of Change (PGIC) scale
Symptom improvement satisfaction is one of the core outcome indicators of overall improvement after treatment. This study used the Patient Global Impression of Change scale (PGIC). Participants were required to rate on a scale from -5 to 5, with each number representing a different condition: 0 represents "no change," -5 represents "very bad," -4 to -1 represent varying degrees of "worse," with lower numbers indicating a worse condition. 1 to 4 represent varying degrees of "recovery," with higher numbers indicating a better condition. 5 represents "complete recovery," meaning the patient has fully recovered to a normal state (Kamper et al., 2009). The Patient-Assessed Overall Improvement Scale is completed by the patient themselves to self-assess the severity of the disease or the effectiveness of the treatment.
Measured: A total of two measurements were taken ( 4 and 8 weeks post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Apr 2025
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910669
- Sponsor's protocol ID
- NYCU113194AE
- Status last verified
- Apr 2026
- First submitted
- 9 Jun 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Pilates Exercise on Chronic Low Back Pain of The Older Adults
- ClinicalTrials.gov ID
- NCT07910669
- Acronym / sponsor ID
- NYCU113194AE
- Conditions
- Chronic Low-back Pain
- Keywords
- chronic low back pain, low back pain, Pilates, middle-aged and elderly adults, hip mobility, gluteus medius, exercise, Pilates exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 2 Nov 2026 (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.
Background: Low-back pain is one of the most common health conditions worldwide. It is defined as pain below the costal margin and above the inferior gluteal folds. Due to aging, older adults experience pain, which can threaten their safety, autonomy, and independence, limit their social interactions, and reduce their quality of life. In exercise therapy, Pilates is considered effective for strengthening core muscles, improving muscle endurance, enhancing spinal control, and promoting trunk stability, thereby minimizing joint load. However, current research has focused on younger populations and lacks detailed descriptions of exercise interventions, making it unclear whether Pilates core exercises would benefit middle-aged and older adults.Therefore, this study incorporates resistance bands and yoga blocks into a Pilates regimen, emphasizing hip mobility exercises and gluteus medius strengthening to enhance the effectiveness of Pilates in treating chronic low back pain. This study aims to design a Pilates exercise therapy program for CLBP that includes hip mobility improvement and gluteus medius training to improve pain, disability level, hip mobility, gluteus medius strength, gluteal endurance, emotional function, participants' ratings of improvement and satisfaction, and participants' intention toward treatment.Purpose: This study targets individuals aged 40 to 69 with chronic low back pain and aims to:Develop an 8-week Pilates core exercise program focusing on gluteal strengthening and increased hip mobility, conducted three times per week for 60 minutes per session, to assess the effectiveness of primary outcome variables (pain, disability) and secondary outcome variables (emotional function, gluteus medius strength, gluteal endurance, hip mobility, satisfaction, self-efficacy).Methods: A single-blind randomized group design will be used in this study. Participants must be aged between 40 and 69 and have had low back pain for more than three months. They will be randomly assigned to either a control group or a Pilates intervention group.Outcome measurement:Outcome measurements include the Visual Analogue Scale (VAS) for pain, the Oswestry Disability Index (ODI), the Beck Depression Inventory (BDI), gluteus medius strength measured by microFET3, hip mobility, self-efficacy for exercise (SEE-C), and the Patient Global Impression of Change (PGIC) scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Pilates exercise8-week Pilates core exercise program focusing on gluteal strengthening and increased hip mobility, conducted three times per week for 60 minutes per session. |
| Control group | No intervention | –Participants in the control group will maintain their normal activities of daily living without any experimental intervention. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Middle-aged and older adults aged 40-69 years.
- Chief complaint of recurrent low back pain located below the costal margin and above the gluteal folds, persisting for more than 3 months (12 weeks) without evidence of structural damage.
- Visual Analogue Scale (VAS) score for pain intensity greater than 30 mm within the past 7 days.
- Chinese version of the Oswestry Disability Index (ODI) score greater than 11 points.
- Diagnosis of chronic low back pain (CLBP) confirmed by a physician or a licensed physical therapist with at least 2 years of clinical experience.
Key exclusion criteria (9 listed)
- Exclusion criteria will consider both current and past conditions. Participants will be excluded if any of the following apply:
- Contraindications, including:Electrocardiographic changes or history of myocardial infarction、Unstable angina、Uncontrolled cardiac arrhythmias、Aortic stenosis、Uncontrolled heart failure、Acute pulmonary embolism or pulmonary infarction、Acute myocarditis or pericarditis、Suspected or confirmed aortic dissection、Acute systemic infection with fever, generalized pain, or lymphadenopathy
- Presence of severe spinal disorders, such as:Fracture
- 、Tumor、.Inflammatory disease、Ankylosing spondylitis、Radiculopathy confirmed by neurological examination
- History of or scheduled for spinal surgery.
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 |
|---|---|---|
| Pilates exerciseDevelop an 8-week Pilates core exercise program focusing on gluteal strengthening and increased hip mobility, conducted three times per week for 60 minutes per session. | Behavioural | Intervention group |
Primary outcome
Pain was measured using a visual analogue scale (VAS).
Time frame: A total of three measurements were taken (one baseline and two post-tests at 4 and 8 weeks post-intervention).
The visual analogue scale consists of a 10-cm line, each labelled at the left end as 'no pain' (0) and at the right end as 'very severe pain' (10).Patients were asked to draw a vertical mark on each line(Delgado et al., 2018).
Disability was assessed using the Oswestry Disability Index (ODI).
Time frame: A total of three measurements were taken (one baseline and two post-tests at 4 and 8 weeks post-intervention).
Disability was assessed using the Oswestry Disability Index. It contains ten items related to limitations in daily life activities, rating each on a 0-5 point scale; the points are added together and converted into a percentage:Minimally disabled (0-10%), moderately disabled(20-40%), severely disabled (40-60%), crippled (60-80%) or bedbound (80-100%)(Rocchi et al., 2005).
5 secondary outcomes
The Beck Depression Scale was used to measure the severity of depressive symptoms among patients(Dworkin et al., 2008).
Time frame: A total of three measurements were taken (one baseline and two post-tests at 4 and 8 weeks post-intervention).
Muscle power measured by microFET3.
Time frame: A total of three measurements were taken (one baseline and two post-tests at 4 and 8 weeks post-intervention).
Hip mobility measured using a GEMRED brand, model: 82311-300 electronic protractor.
Time frame: A total of three measurements were taken (one baseline and two post-tests at 4 and 8 weeks post-intervention).
The Chinese version of the self-efficacy for exercise (SEE-C) scale
Time frame: A total of two measurements were taken ( baseline and 8 weeks post-intervention).
Patient Global Impression of Change (PGIC) scale
Time frame: A total of two measurements were taken ( 4 and 8 weeks post-intervention).
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 Nov 2026.
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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 Pilates exercise in people with Chronic Low-back Pain, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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 5 inclusion and 9 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 Nov 2026. 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 Taiwan. 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 was measured using a visual analogue scale (VAS). (time frame: A total of three measurements were taken (one baseline and two post-tests at 4 and 8 weeks post-intervention).). 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?
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 Nov 2026.