NCT07320469Not yet recruiting
Efficacy of Inspiratory Muscle Trainers on Patients With Obesity and LowBack Pain
Efficacy of Inspiratory Muscle Trainer on Respiratory Functions Exercise Capacity and Pain Intensity in Adults With Obesity and Mechanical Low Back Pain. A Randomized Clinical Trial.
Source: ClinicalTrials.gov · Last updated 6 Jan 2026
Brief summary (registry, in English)
Background: Obesity and mechanical low back pain (MLBP) are two major health problems negatively affecting the human body. Many studies have shown that obesity and MLBP are associated with negative effects on the respiratory system. There are many interventions to treat obesity and MLBP, such as aerobic exercise and diet programs. Moreover, the Inspiratory Muscle Trainer (IMT) significantly improved inspiratory muscle strength in patients with obesity. This study aims to investigate whether adding IMT to aerobic exercise will improve respiratory function, exercise capacity, and pain intensity in patients with obesity and MLBP. Materials and Methods: A total of forty-eight obese patients with MLBP will be equally and randomly assigned to the experimental group and control group. The experimental group will have training on IMT for 6 weeks, three days per week (two sessions daily, thirty breaths per session) using POWERbreathe IMT, starting at 40% of maximal inspiratory pressure with increasing training load at the third week, in addition to having aerobic exercise three times a week for 30 minutes and total body resistance. The control group will have the same training as the experimental group, except for IMT; they will have zero resistance. Main outcome measures: pulmonary function tests and maximal inspiratory pressures to assess respiratory function; VO2 to assess exercise capacity; pain intensity; and Oswestry Disability Index to determine functional disability. All the measurements will be done before and after the intervention in both groups. Paired and independent t-tests will be used to compare within- and between-group differences. A repeated-measures design will be used to determine significant differences before, during, and after the intervention within each group.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 16 Nov 2025
- Start date
- 1 Mar 2026
- Primary completion date
- 30 Aug 2026
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Diseases
- Obesity
- NCT number
- NCT07320469
What you commit to
- Study type: Interventional
- Planned participants: 48
- From 1 Mar 2026 to the primary completion date, 30 Aug 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe spinal pathology, e.g., infection, tumor, arthritis, inflammation, spine deformity, advanced neurologic diseases, head or spinal surgeries, rheumatic diseases, and respiratory muscle paralysis
Other
- Medically unstable
- Acute inflammation of the musculoskeletal system
- Pregnancy
- Unable to follow instructions, e.g., those with learning difficulties
Who the study is looking for
- Males and females
- Aged between 20 and 50 years
- Obese and experiencing mechanical low back pain (MLBP)
- A body mass index (BMI) between 30 and 40 kg/m²
- low back pain for more than 12 weeks, with pain localized to the lumbar region - A pain score greater than 3 but less than 7 on the Numeric Pain Rating Scale (NPRS).
- Low back pain will be screened using the Mechanical and Inflammatory Low Back Pain (MIL) Index.
- Stable and controlled medical conditions
Age in the registry: 20 years to 55 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.