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

December 4, 2025 updated by: Kimberley Edwards, University of Nottingham

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Notts
      • Nottingham, Notts, United Kingdom, NG7 2UH
        • Recruiting
        • University of Nottingham, Queen's Medical Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
VAS pain score
Time Frame: Baseline, 8 weeks, 12 months

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Oswestry disability index
Time Frame: Baseline, 8 weeks, 12 months

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
Time Frame: Baseline, 8 weeks, 12 months

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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: During the 8 week intervention (weekly)
Use the exercise data to assess adherence to the allocated exercise programme.
During the 8 week intervention (weekly)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nottingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kimberley Edwards, University of Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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