Skip to main content
OpenTrials
Completed

NCT Number: NCT07787598

High-Intensity Interval Training in Young Women With Mechanical Low Back Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MTI university

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

**Inclusion Criteria:**

  • Female participants aged 20 to 38 years.
  • Mild to moderate nonspecific low back pain persisting for more than 3 months.
  • Low back pain without an identifiable specific pathological cause.
  • Body mass index (BMI) between 18.5 and 34.9 kg/m².
  • Able to participate safely in the prescribed cycling exercise intervention.

**Exclusion Criteria:**

  • Pregnancy or lactation.
  • Recent surgery.
  • Any chronic medical condition that restricts physical activity or exercise participation.
  • Secondary causes of low back pain.
  • Osteoporosis.
  • Osteoarthritis.
  • Sciatica.
  • Generalized neuromuscular disorders.
  • Structural spinal deformities.
  • Vertebral or other relevant fractures.
  • Reliance on assistive walking devices.
  • Cardiovascular disease that could compromise safe participation in cycling exercise.
  • Respiratory disease that could compromise safe participation in cycling exercise.
  • Autonomic dysfunction, including diabetes mellitus.
  • Current use of medications known to affect heart rate variability, including beta-blockers or calcium channel blockers.

Treatment and study plan

HIIT

Other

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).

Low Intensity Training

Other

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.

Primary outcomes

  1. Oswestry Disability Index (ODI)

    Time frame: Baseline (pre-intervention) and immediately post-intervention at 4 weeks

    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.

  2. Visual Analog Scale (VAS)

    Time frame: Baseline (pre-intervention) and immediately post-intervention at 4 weeks

    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.

  3. Body Composition Parameters

    Time frame: Baseline (pre-intervention) and immediately post-intervention at 4 weeks

    Body composition was assessed using bioelectrical impedance analysis with the InBody 700 system. The assessed parameters included percentage body fat and skeletal muscle mass.

  4. Maximal Oxygen Uptake (VO₂ max)

    Time frame: Baseline (pre-intervention) and immediately post-intervention at 4 weeks

    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.

  5. Quality of Life Scale (QOLS)

    Time frame: Baseline (pre-intervention) and immediately post-intervention at 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

MTI University

Other

Registry information

Official study title

Effect of High-Intensity Interval Training on Pain, Functional Ability, and Body Composition in Young Women With Mechanical Low Back Pain

Acronym: HIIT-LBP

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.