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

Sponsor
Imam Abdulrahman Bin Faisal University
Study ID
NCT07320469
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 55 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

First listed
Jan 6, 2026
Start date
Mar 1, 2026
Status verified
Dec 2025
Primary completion
Aug 30, 2026
Completion
Aug 30, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Experimental group : IMT with 40%Of MIP +walking +resisancee training
    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.
  • Placebo Comparator: Control group: IMT with 0% of MIP +walking +resistance training
    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.

Primary Outcome Measure

Pulmonary Function Test [ Time Frame: 6 weeks ]

Central Contacts

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