NCT07787598

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Nov 2024

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 26, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 26, 2026

Completed
Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

July 21, 2026

Last Update Submit

August 21, 2026

Conditions

Keywords

mechanical low back painHIITfunctional abilitybody compositionVO₂ max

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

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

Study Arms (2)

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).

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.

Other: low intensity training

Interventions

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).

The HIIT group

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.

The control group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale participants aged 20 to 38 years.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MTI university

Cairo, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trial with two parallel groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Department of woman and Child Health, Faculty of Physical Therapy, Beni Suef University

Study Record Dates

First Submitted

July 21, 2026

First Posted

August 26, 2026

Study Start

November 26, 2024

Primary Completion

November 26, 2025

Study Completion

July 22, 2026

Last Updated

August 26, 2026

Record last verified: 2026-08

Locations