Low Back Pain, ChronicNCT06921694
A Combined Exercise Programme Involving Strengthening, Flexibility and Aerobic Exercise for Lower Back Pain
A study testing Runner group and Swim/Cycle Group in people with Low Back Pain, Chronic, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Chronic
- What is being tested?
- Runner group and Swim/Cycle Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Nottingham, Queen's Medical Centre
Nottingham, Notts, NG7 2UH
Professor Sport Exercise and Nutrition Education, +44 1157486500, kimberley.edwards@nottingham.ac.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Back Pain, Chronic
- Being tested
- Runner group, Swim/Cycle Group
- Keywords
- chronic non specific low back pain, exercise intervention
- Medical subject headings
- Low Back Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Runner groupBehavioural
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
Swim/Cycle GroupBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Swim/Cycle Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 8 weeks, 12 months
Secondary outcomes (2)
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
Measured: 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
Measured: Baseline, 8 weeks, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Apr 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, ChronicStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberley Edwards, University of Nottingham
- Investigators
- Kimberley Edwards, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921694
- Sponsor's protocol ID
- FMHS 279 0423
- Status last verified
- Apr 2025
- First submitted
- 26 Mar 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is a small study with limited administrative support.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined Exercise Programme Involving Strengthening, Flexibility and Aerobic Exercise for Lower Back Pain: a Randomised-controlled Study
- ClinicalTrials.gov ID
- NCT06921694
- Acronym / sponsor ID
- FMHS 279 0423
- Conditions
- Low Back Pain, Chronic
- Keywords
- chronic non specific low back pain, exercise intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants continue with their usual exercise regime. |
| Runner Group | Experimental | Behavioral: Runner groupParticpants follow an 8 week intervention including aerobic elements (running), a schedule of gradually intensitfing strengthening exercises and flexibility exercises. |
| Swim/Cycle group | Experimental | Behavioral: Swim/Cycle GroupParticpants follow an 8 week intervention including aerobic elements (swim/cycle), a schedule of gradually intensitfing strengthening exercises and flexibility exercises. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Runner groupThe intervention groups undertake 8 weeks of a combined exercise programme including aerobic elements (running), a schedule of gradually intensifying strengthening exercises and flexibility exercises | Behavioural | Runner Group |
| Swim/Cycle GroupThe 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 | Behavioural | Swim/Cycle group |
Primary outcome
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
2 secondary outcomes
Oswestry disability index
Time frame: Baseline, 8 weeks, 12 months
Roland Morris Disability questionnaire
Time frame: Baseline, 8 weeks, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Undecided. This is a small study with limited administrative support.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University of Nottingham, Queen's Medical Centre
Nottingham, United Kingdom
Kimberley Edwards principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Runner group and Swim/Cycle Group in people with Low Back Pain, Chronic, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS pain score (time frame: Baseline, 8 weeks, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.