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

Not Applicable

Not yet recruiting

• Conditions: Low Back Pain, Chronic

• Registration Number: NCT06921694
• Lead Sponsor: University of Nottingham

Brief Summary

This study will recruit from the community otherwise healthy participants with low back pain to take part in an 8 week intervention. There are 3 arms - a control arm of usual exercise; a running intervention group; and a swim/cycle intervention group. The intervention groups undertake 8 weeks of a combined exercise programme including aerobic elements (running or swim/cycle), a schedule of gradually intensifying strengthening exercises and flexibility exercises. There are baseline, 8 week and 1 year questionnaires including validated PROMS to determine pain and function.

Detailed Description

This study will recruit from the community otherwise healthy participants with low back pain to take part in an 8 week intervention. There are 3 arms - a control arm of usual exercise; a running intervention group; and a swim/cycle intervention group. The intervention groups undertake 8 weeks of a combined exercise programme including aerobic elements (running or swim/cycle), a schedule of gradually intensifying strengthening exercises and flexibility exercises. There are baseline, 8 week and 1 year questionnaires including validated PROMS to determine pain and function.

Study Timeline

• Study First Submitted: 2025-03-26
• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Submitted QC: 2025-04-03
• Last Update Submitted: 2025-04-03
• Study First Posted: 2025-04-10
• Last Update Posted: 2025-04-10
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
VAS pain score	Baseline, 8 weeks, 12 months	VAS pain score on 100 point scale
Oswestry disability index	Baseline, 8 weeks, 12 months	Oswestry disability index (PROM questionnaire)
Roland Morris Disability questionnaire	Baseline, 8 weeks, 12 months	Roland Morris Disability questionnaire (PROM questionnaire)

Secondary Outcome Measures

Name	Time	Method
Exercise data	During the 8 week intervention (weekly)	exercise data (type, duration, intensity, frequency of exercises).

Trial Locations

Locations (1)

University of Nottingham, Queen's Medical Centre; 🇬🇧 Nottingham, Notts, United Kingdom