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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain, Chronic
• Intervention / Treatment: Behavioral: Runner group; Behavioral: Swim/Cycle Group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Notts
    • Nottingham, Notts, United Kingdom, NG7 2UH
      • Recruiting
      • University of Nottingham, Queen's Medical Centre
      • Contact: Professor Sport Exercise and Nutrition Education; Phone Number: +44 1157486500; Email: kimberley.edwards@nottingham.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Participants continue with their usual exercise regime.
Experimental: Runner Group; Particpants follow an 8 week intervention including aerobic elements (running), a schedule of gradually intensitfing strengthening exercises and flexibility exercises.	Behavioral: Runner group; 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
Experimental: Swim/Cycle group; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry disability index	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	Baseline, 8 weeks, 12 months
Roland Morris Disability questionnaire	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	Baseline, 8 weeks, 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	Use the exercise data to assess adherence to the allocated exercise programme.	During the 8 week intervention (weekly)

Collaborators and Investigators

• Sponsor: University of Nottingham
• Investigators: Principal Investigator: Kimberley Edwards, University of Nottingham

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: exercise intervention; chronic non specific low back pain
• Additional Relevant MeSH Terms: Organizing Pneumonia; Pain; Neurologic Manifestations; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Back Pain; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Graft vs Host Disease; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Bronchiolitis Obliterans Syndrome; Low Back Pain
• Other Study ID Numbers: FMHS 279 0423

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This is a small study with limited administrative support.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No