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

Qualifiers

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

Treatments tested in this trial

  • Inspiratory muscle trainer

Treatment groups

48 Participants
are divided into 2 treatment groups

Locations

This trial has no locations