An interventional study of Pilates exercise in Chronic Low-back Pain, sponsored by National Yang Ming Chiao Tung University. Completed at 1 site in Taiwan. Open to participants aged 40 Years to 69 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by National Yang Ming Chiao Tung University · Not applicable, Interventional, and Treatment
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.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →National Yang Ming Chiao Tung University is the lead sponsor of 208 studies on the registry; 60 are open to participants now.
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Exclusion Criteria
Exclusion criteria will consider both current and past conditions. Participants will be excluded if any of the following apply:
Presence of severe spinal disorders, such as:Fracture
、Tumor、.Inflammatory disease、Ankylosing spondylitis、Radiculopathy confirmed by neurological examination
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
8-week Pilates core exercise program focusing on gluteal strengthening and increased hip mobility, conducted three times per week for 60 minutes per session.
Behavioral: Pilates exercise
Participants in the control group will maintain their normal activities of daily living without any experimental intervention.
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.
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).
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 (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).
Time frame: A total of three measurements were taken (one baseline and two post-tests at 4 and 8 weeks post-intervention).
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).
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.
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."
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.
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.
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
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.
Time frame: 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.
Time frame: A total of two measurements were taken ( 4 and 8 weeks post-intervention).
Ran from Apr 2025 to primary completion in Feb 2026, 10 months.
Of 1,231 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's 10 months is close to that.
Counting every sponsor, half of 1,286 studies reached it within 11 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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