Low Back PainHIIT-LBPNCT07787598
High-Intensity Interval Training in Young Women With Mechanical Low Back Pain
A study testing HIIT and low intensity training in people with Low Back Pain, run by MTI University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Low Back Pain
- What is being tested?
- HIIT and low intensity training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Nov 2024to 22 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy or lactation.
- Recent surgery.
- Any chronic medical condition that restricts physical activity or exercise participation.
- Secondary causes of low back pain.
- Osteoporosis.
- Osteoarthritis.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of High-Intensity Interval Training on Pain, Functional Ability, and Body Composition 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.
Read the detailed description
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.
- Conditions
- Low Back Pain
- Being tested
- HIIT, low intensity training
- Keywords
- mechanical low back pain, HIIT, functional ability, body composition, VO₂ max
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIITOther
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 trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| The HIIT group | Experimental | 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). Receives: Other: HIIT |
| The control group | Active comparator | 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. Receives: Other: low intensity training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (pre-intervention) and immediately post-intervention at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start26 Nov 2024
- Primary completion26 Nov 2025
- Study completion22 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial with two parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Mohammed, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787598
- Sponsor's protocol ID
- REC/2111/MTI.PT/2411261
- Acronym
- HIIT-LBP
- Status last verified
- Aug 2026
- First submitted
- 21 Jul 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-Intensity Interval Training on Pain, Functional Ability, and Body Composition in Young Women With Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT07787598
- Acronym / sponsor ID
- HIIT-LBP / REC/2111/MTI.PT/2411261
- Conditions
- Low Back Pain
- Keywords
- mechanical low back pain, HIIT, functional ability, body composition, VO₂ max
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 22 Jul 2026 (actual)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial with two parallel groups
| Arm | Type | Receives |
|---|---|---|
| The HIIT group | Experimental | Other: HIITparticipated 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). |
| The control group | Active comparator | Other: low intensity trainingperformed 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- Pregnancy or lactation.
- Recent surgery.
- Any chronic medical condition that restricts physical activity or exercise participation.
- Secondary causes of low back pain.
- Osteoporosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIITparticipated 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 | The HIIT group |
| low intensity trainingperformed 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 | The control group |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT and low intensity training in people with Low Back Pain, run by MTI University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (ODI) (time frame: Baseline (pre-intervention) and immediately post-intervention at 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.