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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 主要终点
- Pulmonary Function Test
研究概览
简要总结
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.
详细描述
The aim of this study is to investigate the effects of inspiratory muscle trainers on respiratory function, exercise capacity, pain intensity, and functional disability in patients with obesity and MLBP. If a significant improvement is found, IMT could be added to the guidelines for exercise prescriptions for obese patients with MLBP. Therefore, this study might provide evidence-based findings to guide clinical decision-making and empower clinicians and healthcare organizations to incorporate IMT into exercise prescription guidelines for obese patients with MLBP. By integrating IMT into guidelines, this study might enhance rehabilitation strategies for obese patients with MLBP.
Hypothesis
- Null Hypothesis: the addition of IMT to aerobic exercise does not result in significant differences in respiratory functions, exercise capacity, pain intensity, and functional disability in patients with obesity and mechanical low back pain.
- Alternative Hypothesis: the addition of IMT to aerobic exercise results in significant differences in respiratory functions, exercise capacity, pain intensity, and functional disability in patients with obesity and mechanical low back pain.
Objectives of the study:
- To assess the effects of PowerBreathIMT on pulmonary function tests and maximum inspiratory pressure in patients with obesity and mechanical low back pain.
- To assess the effects of PowerBreathIMT on exercise capacity, pain intensity and functional disability in patients with obesity and mechanical low back pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Each participant will be stratified and assigned either to a control or experimental group based on age, pain score and BMI.
Blinding & Randomization will be performed by computer-generated numbers from www.randomizer.org. A random number generator will make a serial number for each participant. Both participants and the assessor will be blinded. Participants will be randomized into the experimental group; they will practice an aerobic exercise and resistance training program in addition to IMT with resistance set at 40% of each participant's maximum inspiratory pressure, while all participants of the control group will practice aerobic exercise and resistance training in addition to IMT with no resistance (Ponde et al., 2021 & Medicine, 2014).
入排标准
- 年龄范围
- 20 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •Unable to follow instructions, e.g., those with learning difficulties
结局指标
主要结局
Pulmonary Function Test
时间窗: 6 weeks
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.
Maximal Inspiratory Pressure
时间窗: 6 weeks
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.
次要结局
- Maximal O2 uptake (VO2 max)(6 weeks)
- Pain intensity(6 weeks)
- Body composition(6 weeks)
- Oswestry Disability Index (Arabic Version)(6 weeks)
研究者
Maali Mohammed Alqahtani
Lecturer
Imam Abdulrahman Bin Faisal University
