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NCT Number: NCT06921694

A Combined Exercise Programme Involving Strengthening, Flexibility and Aerobic Exercise for Lower Back Pain

This randomised controlled trial will evaluate the effectiveness of different exercise modalities for individuals with low back pain. Participants will be allocated to one of three groups: a control arm (usual exercise), a running-based intervention, or a swimming/cycling-based intervention. Outcomes related to pain and function will be measured at baseline, 8 weeks, and 12 months.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nottingham, Queen's Medical Centre

Nottingham, Notts, NG7 2UH, United Kingdom

Location status: Recruiting

Location contact

Professor Sport Exercise and Nutrition Education

CONTACT

[email protected]

+44 1157486500

About this study

This study is designed to assess the impact of structured exercise interventions on pain and functional outcomes in otherwise healthy adults with low back pain. Eligible participants recruited from the community will be randomised into one of three arms: (1) control group, continuing their usual exercise activities; (2) running intervention group; or (3) swimming/cycling intervention group.

The two intervention arms will complete an 8-week combined exercise programme consisting of aerobic training (running or swimming/cycling, depending on group assignment), progressive resistance training, and prescribed flexibility exercises. The programme is structured to gradually increase in intensity over the 8-week period to enhance adherence and minimize risk of injury.

Efficacy will be evaluated using validated patient-reported outcome measures (PROMs) capturing pain intensity and functional capacity. These assessments will be administered at three time points: baseline (prior to the intervention), post-intervention (8 weeks), and long-term follow-up (12 months). This design will enable analysis of both the short-term and sustained effects of exercise modality on low back pain management.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 18-45 years
  • Participant is willing and able to give informed consent for participation in the study
  • Suffering from chronic NSLBP (more than 3 months, localised below the costal margin and above the gluteal folds)
  • Suffers from pain or functional limitations as a result of their LBP (minimum VAS (back) score of 3/10 or ODI score of at least 5/50 or RMD score of at least 5/24 (note, unlike ODI, RMD does not describe specific cuts offs for different levels of disability)
  • Able to exercise

Exclusion criteria

  • Radiating pain to leg / sciatica / acute radiculopathy
  • Specific diagnosis/condition for LBP (e.g. herniated disk, degenerative disk disease, spondylolysis, spinal stenosis, spinal tumour, facet joint damage)
  • History of osteoporosis , arthritis, scoliosis, or kyphosis.
  • Current spinal infection, cancer or a current fracture (any bone).
  • History of spinal/back surgery
  • Unable to participate in physical activity and exercise
  • Pregnant or breast feeding
  • History of substance abuse
  • History of psychiatric illness (eg. depression, dementia, schizophrenia) for which currently taking medication
  • History or current neurological condition (e.g. epilepsy)
  • Not in possession or have access to adapted equipment (phone, computer, functioning WIFI)
  • Unable to understand and communicate in English
  • Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance

Treatment and study plan

Runner group

Behavioral

The intervention groups undertake 8 weeks of a combined exercise programme including aerobic elements (running), a schedule of gradually intensifying strengthening exercises and flexibility exercises

Swim/Cycle Group

Behavioral

The intervention groups undertake 8 weeks of a combined exercise programme including aerobic elements (swim/cycle), a schedule of gradually intensitfing strengthening exercises and flexibility exercises

Primary outcomes

  1. VAS pain score

    Time frame: Baseline, 8 weeks, 12 months

    VAS pain score on 100 point scale

    • Range: 0 to 100
    • Anchors: 0 = no pain, 100 = worst imaginable pain
    • Interpretation: Higher scores indicate worse pain

Secondary outcomes

  1. Oswestry disability index

    Time frame: Baseline, 8 weeks, 12 months

    Oswestry disability index (PROM questionnaire)

    • Range: 0 to 100 (expressed as a percentage)
    • Anchors: 0 = no disability, 100 = maximum disability
    • Interpretation: Higher scores indicate greater disability
  2. Roland Morris Disability questionnaire

    Time frame: Baseline, 8 weeks, 12 months

    Roland Morris Disability questionnaire (PROM questionnaire)

    • Range: 0 to 24 (some versions extend to 0-23 or 0-25 depending on adaptation, but 0-24 is most common)
    • Anchors: 0 = no disability, 24 = maximum disability
    • Interpretation: Higher scores indicate greater disability

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

A Combined Exercise Programme Involving Strengthening, Flexibility and Aerobic Exercise for Lower Back Pain: a Randomised-controlled Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 10, 2025
Registry last updated
Dec 12, 2025

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.

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