An interventional study of HIIT and low intensity training in Low Back Pain, sponsored by MTI University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by MTI University · Not applicable, Interventional, and Treatment
This randomized controlled trial evaluated the effects of a 4-week high-intensity interval training (HIIT) program on pain, functional disability, body composition, cardiorespiratory fitness, and quality of life in young women with mechanical low back pain. Participants were randomly allocated to either a supervised HIIT cycling program or a control exercise program consisting of stretching and low- to moderate-intensity treadmill walking. Outcomes were assessed at baseline and after completion of the 4-week intervention.
This randomized controlled trial used a two-arm parallel-group design to investigate the effects of a 4-week high-intensity interval training (HIIT) program on pain, functional disability, body composition, cardiorespiratory fitness, and quality of life in young women with mechanical low back pain.
The study was conducted at the outpatient and physiotherapy clinics of MTI University. Ethical approval was obtained from the Institutional Review Board of MTI University (approval number REC/2111/MTI.PT/2411261), and the study was conducted in accordance with the principles of the Declaration of Helsinki. The trial was retrospectively registered on ClinicalTrials.gov because of administrative delays.
Eligible participants were women aged 20-38 years with mild-to-moderate nonspecific mechanical low back pain persisting for more than three months. Participants were screened according to predefined eligibility criteria. Exclusion criteria included pregnancy or lactation, recent surgery, secondary causes of low back pain, osteoporosis, osteoarthritis, sciatica, generalized neuromuscular disorders, structural deformities, fractures, conditions restricting physical activity, cardiovascular or respiratory conditions that could compromise exercise safety, autonomic dysfunction, and use of medications that could affect heart-rate responses.
Participants were randomly allocated to either the HIIT group or the control exercise group using a computer-generated random sequence with permuted blocks of 4 and 6. Randomization was stratified according to baseline pain severity (VAS ≤5 versus >5). Allocation concealment was maintained using sequentially numbered, sealed, opaque envelopes prepared by a researcher who was not involved in participant recruitment or outcome assessment. Due to the nature of the exercise interventions, participant blinding was not feasible.
The HIIT group participated in supervised cycling sessions three times per week for 4 weeks. Each session lasted approximately 30-40 minutes and included a warm-up, repeated high-intensity cycling intervals, recovery periods, and a cool-down. High-intensity intervals were performed at approximately 80% of maximum heart rate, with heart rate continuously monitored during training. Sessions were supervised by a licensed physiotherapist.
The control group participated in supervised low- to moderate-intensity exercise consisting of stretching and treadmill walking performed at approximately 40-60% of maximum heart rate. Exercise intensity was monitored using heart-rate monitoring.
Outcomes were assessed at baseline and after completion of the 4-week intervention. Pain intensity was assessed using the Visual Analog Scale (VAS). Functional disability was assessed using the Oswestry Disability Index (ODI). Body composition, including fat mass percentage and muscle mass, was assessed using bioelectrical impedance analysis. Cardiorespiratory fitness was assessed by measuring maximal oxygen uptake (VO₂ max) using cardiopulmonary exercise testing. Quality of life was assessed using the Quality-of-Life Scale (QOLS).
Adverse events were monitored throughout the supervised exercise sessions. Participants were instructed to report symptoms including dizziness, excessive fatigue, exacerbation of musculoskeletal pain, or cardiovascular discomfort.
Statistical analyses were conducted using SPSS. Data distribution was assessed before statistical analysis. Appropriate statistical tests were used to evaluate within-group changes and between-group differences. Effect sizes were calculated to quantify the magnitude of observed differences, and statistical significance was assessed using a two-sided p-value threshold of \<0.05.
**Inclusion Criteria:**
**Exclusion Criteria:**
participated in supervised cycling sessions lasting 30-40 minutes, three times per week, performed at intensities ranging from 80% to 90% of maximum heart rate (HRmax).
Other: HIIT
performed supervised moderate- to low-intensity exercises, including stretching and treadmill walking at 40-60% HRmax, for 30-40 minutes, with heart rate monitoring to regulate exercise intensity.
Other: low intensity training
participated in supervised cycling sessions lasting 30-40 minutes, three times per week, performed at intensities ranging from 80% to 90% of maximum heart rate (HRmax).
performed supervised moderate- to low-intensity exercises, including stretching and treadmill walking at 40-60% HRmax, for 30-40 minutes, with heart rate monitoring to regulate exercise intensity.
Oswestry Disability Index (ODI)
Functional disability was assessed using the Oswestry Disability Index (ODI), a validated self-reported questionnaire for assessing disability related to low back pain. Total scores range from 0 to 100, with higher scores indicating greater disability.
Time frame: Baseline (pre-intervention) and immediately post-intervention at 4 weeks
Visual Analog Scale (VAS)
Pain intensity was assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Time frame: Baseline (pre-intervention) and immediately post-intervention at 4 weeks
Body Composition Parameters
Body composition was assessed using bioelectrical impedance analysis with the InBody 700 system. The assessed parameters included percentage body fat and skeletal muscle mass.
Time frame: Baseline (pre-intervention) and immediately post-intervention at 4 weeks
Maximal Oxygen Uptake (VO₂ max)
Cardiorespiratory fitness was assessed by measuring maximal oxygen uptake (VO₂ max) using the COSMED Quark CPET system during a graded exercise test. VO₂ max was expressed in mL/kg/min, with higher values indicating better cardiorespiratory fitness.
Time frame: Baseline (pre-intervention) and immediately post-intervention at 4 weeks
Quality of Life Scale (QOLS)
Quality of life was assessed using the Quality of Life Scale (QOLS), a multidimensional instrument assessing physical, social, and psychological aspects of quality of life. Total scores range from 16 to 112, with higher scores indicating better quality of life.
Time frame: Baseline (pre-intervention) and immediately post-intervention at 4 weeks
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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