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

University of Nottingham

Status: Enrolling

Conditions: Low Back Pain, Chronic

Treatments: Behavioral: Runner group; Behavioral: Swim/Cycle Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06921694

FMHS 279 0423

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 3 patient groups

Control Group

No Intervention group

Description:

Participants continue with their usual exercise regime.

Runner Group

Experimental group

Description:

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

Treatment:

Behavioral: Runner group

Swim/Cycle group

Experimental group

Description:

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

Treatment:

Behavioral: Swim/Cycle Group