Efficacy of Inspiratory Muscle Trainers on Patients With Obesity and LowBack Pain

NCT07320469 | Not Yet Recruiting DMC

• 1 other identifier: IRB-PGS-2025-03-0528
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obesity; Low Back Pain

Keywords

obesity; low back pain; obesity and low back pain; inspiratory muscle trainers; respiratory function; exercise capacity; functional disability; pain intensity; body compisition

Outcome Measures

Primary Outcomes (2)

• 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.

  6 weeks

• 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.

  6 weeks

Secondary Outcomes (4)

• Maximal O2 uptake (VO2 max)

  6 weeks

• Pain intensity

  6 weeks

• Body composition

  6 weeks

• Oswestry Disability Index (Arabic Version)

  6 weeks

Study Arms (2)

Experimental group : IMT with 40%Of MIP +walking +resisancee training

EXPERIMENTAL

Experimental Group: Twenty-four participants will practice aerobic exercise (30 minutes of walking at 40-60% of HRmax) and resistance training in addition to IMT (starting resistance level of 40%) three times a week for six weeks. Home program: All participants of both groups will also perform different exercises, including aerobic, resistive, and IMT training two times per week at home. The participants from both groups will receive detailed instructions to guide them in performing home sessions. Follow up with them through WhatsApp and Zoom, and call them every other day to check their performance and encourage them. Participants will also have logbooks for documentation and to count the adherence and compliance.

Device: Inspiratory muscle trainer

Control group: IMT with 0% of MIP +walking +resistance training

PLACEBO COMPARATOR

Twenty-four participants will practice aerobic exercise (30 minutes of walking at 40-60% of HRmax) and resistance training in addition to IMT (starting resistance level of 0%) three times a week for six weeks. Home program: All participants of both groups will also perform different exercises, including aerobic, resistive, and IMT training two times per week at home. The participants from both groups will receive detailed instructions to guide them in performing home sessions. Follow up with them through WhatsApp and Zoom, and call them every other day to check their performance and encourage them. Participants will also have logbooks for documentation and to count the adherence and compliance.

Device: Inspiratory muscle trainer

Interventions

Inspiratory muscle trainer DEVICE

Inspiratory 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.

Control group: IMT with 0% of MIP +walking +resistance training; Experimental group : IMT with 40%Of MIP +walking +resisancee training

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

MeSH Terms

Conditions

Obesity; Low Back Pain; Respiratory Aspiration; Pain

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain; Neurologic Manifestations; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Study Officials

• Maali M Alqahtani, Master

  Imam Andulrahman BinFaisal University

  PRINCIPAL INVESTIGATOR

• Alsayed M Shanab, PhD

  Imam Abdulrahman BinFaisal University

  STUDY DIRECTOR

Central Study Contacts

Maali M Alqahtani, master

CONTACT

0568899888; maalqahtani@iau.edu.sa

Alsayed Shanab, PhD

CONTACT

0555786349; aashanb@iau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: The study design will be a parallel-group, double-blind, randomised controlled trial.After referral from the orthopedic or neurology clinic to the Respiratory Care (RC) Department, participants will undergo screening for low back pain to include only those diagnosed with mechanical low back pain. Following this, the assessor will record each participant's demographic data, including gender, age, BMI, blood pressure (BP), heart rate (HR), duration of pain, and pain severity using the Numerical Pain Rating Scale (NPRS). A Bioelectrical Impedance Analysis (BIA) device will be used to measure fat-free mass, fat percentage, and body cell mass before and after the training intervention (Schoeller, 2000). Baseline measurements will be taken prior to the intervention and again after six weeks by a blinded assessor.

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: January 6, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12