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

Sponsor: University of Nottingham

NCT ID: NCT06921694

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Runner group (behavioural), Swim/Cycle Group (behavioural)
How long the study runs
Study runs about 17 months (dates as stated)
About the drug or intervention
Runner group — behavioural: 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 — behavioural: 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
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 45 Years
Who
All
Number of participants
88
Started
2025-04-01
Last checked
2025-04

Plain English Summary

What is this study?

  • • Testing a new treatment for low back pain, chronic
  • • NA - 88 participants
  • • This randomised controlled trial will evaluate the effectiveness of different exercise modalities for individuals with low back pain

Who can take part?

  • • Ages 18 Years to 45 Years
  • • Diagnosed with low back pain, chronic

Where?

  • • Nottingham - University of Nottingham, Queen's Medical Centre

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Low Back Pain, Chronic

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 45 Years
  • Who can join: All genders

What the study is looking for

  • ✓Aged 18-45 years
  • ✓Participant is willing and able to give agreement to take part for participation in the study
  • ✓Suffering from chronic NSLBP (more than 3 months, localised below the costal margin and above the gluteal folds)
  • ✓Able to exercise

Who cannot take part

  • ✗Radiating pain to leg / sciatica / acute radiculopathy
  • ✗Specific diagnosis/condition for LBP (e.g. herniated disk, degenerative disk disease, spondylolysis, spinal...
  • ✗History of osteoporosis , arthritis, scoliosis, or kyphosis.
  • ✗Current spinal infection, cancer or a current fracture (any bone).
  • ✗History of spinal/back surgery
See the full criteria
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

Where Is This Study? (1 UK site)

University of Nottingham, Queen's Medical Centre

Nottingham NG7 2UH, United Kingdom

Recruiting
Site contact (verified)
Professor Sport Exercise and Nutrition Education+44 1157486500kimberley.edwards@nottingham.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-04