Efficacy of Inspiratory Muscle Trainers on Patients With Obesity and LowBack Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-55
SponsorImam Abdulrahman Bin Faisal University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Medically unstable
Severe spinal pathology, e.g., infection, tumor, arthritis, inflammation, spine deformity, advanced neurologic diseases, head or spinal surgeries, rheumatic diseases, and respiratory muscle paralysis
Acute inflammation of the musculoskeletal system
Pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Inspiratory muscle trainer
DeviceInspiratory muscle trainer: The POWER breath device has a variable resistance, which can be adjusted by a calibrated spring. The initial resistance training level will be adjusted at 0% resistance for the control group and 40% of MIP for the experimental group. The participants will be instructed to use the device twice daily (two times per day, in the hospital under supervision, 30 breaths in each session) for three days a week for 6 weeks, with periods of rest, especially if the patient feels dizzy or fatigued.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Experimental group : IMT with 40%Of MIP +walking +resisancee trainingExperimental treatment 1 intervention
Group B: Control group: IMT with 0% of MIP +walking +resistance trainingPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pulmonary Function Test
a. Pulmonary Function Tests: are essential for assessing lung function and are highly valid and reliable. Spirometry will be used to assess pulmonary function following standard maneuvers.
Time frame
6 weeks2
Maximal Inspiratory Pressure
b. Maximum Inspiratory Pressure (MIP) is a reliable and valid measure of inspiratory muscle strength, influenced by factors such as age, sex, height, and weight. It demonstrates good test-retest reliability and strong concurrent validity when compared with reference tests in COPD patients. It will be measured by cmH₂O.
Time frame
6 weeksSecondary outcomes
1
Maximal O2 uptake (VO2 max)
a. Maximal O₂ uptake (VO₂ max) is the gold standard for assessing cardiovascular fitness and aerobic capacity, showing excellent validity and reliability. VO₂ max reflects the efficiency of the cardiovascular and respiratory systems in oxygen delivery and utilization. It is measured by ml/kg/min.
Time frame
6 weeks2
Pain intensity
Pain intensity will be assessed using the 11-point Numerical Pain Rating Scale (NPRS), ranging from 0 ("no pain") to 10 ("worst imaginable pain"). The NPRS shows excellent reliability and strong validity.
Time frame
6 weeks3
Body composition
Body composition will be measured using a bioelectrical impedance analyzer (BIA), which estimates body composition by measuring the body's impedance to a small electrical current. By using personal data, the device provides valid and reliable measurements across populations. The measurement will be by Body Mass Index, which is expressed as KG/M². BIA assessments will be conducted before and after training to compare changes in body composition.
Time frame
6 weeks4
Oswestry Disability Index (Arabic Version)
The questionnaire will be administered to both groups before and after the intervention. It is a valid and reliable tool that assesses the impact of back pain on daily activities. It includes 10 sections covering various life aspects, including pain intensity. Scores are interpreted as follows: 0-20% = minimal disability, 21-40% = moderate disability, 41-60% = severe disability, and 81-100% = exaggerated symptoms and severe impairment, requiring urgent intervention.
Time frame
6 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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