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

NCT06921694 | Recruiting

• 1 other identifier: FMHS 279 0423
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain, Chronic

Keywords

chronic non specific low back pain; exercise intervention

Outcome Measures

Primary Outcomes (1)

• VAS pain score

  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

  Baseline, 8 weeks, 12 months

Secondary Outcomes (2)

• Oswestry disability index

  Baseline, 8 weeks, 12 months

• Roland Morris Disability questionnaire

  Baseline, 8 weeks, 12 months

Study Arms (3)

Control Group

NO INTERVENTION

Participants continue with their usual exercise regime.

Runner Group

EXPERIMENTAL

Particpants follow an 8 week intervention including aerobic elements (running), a schedule of gradually intensitfing strengthening exercises and flexibility exercises.

Behavioral: Runner group

Swim/Cycle group

EXPERIMENTAL

Particpants follow an 8 week intervention including aerobic elements (swim/cycle), a schedule of gradually intensitfing strengthening exercises and flexibility exercises.

Behavioral: Swim/Cycle Group

Interventions

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

Runner Group

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

Swim/Cycle group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham, Queen's Medical Centre

Nottingham, Notts, NG7 2UH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Kimberley Edwards

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is not possible to blind/mask the investigators or participants due to the nature of the intervention (i.e. they know what exercise they are doing). However a different person undertakes the randomisation to keep that separate.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Sport Exercise and Nutrition Education

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 10, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-04

Locations

GB (1)