COPD (Chronic Obstructive Pulmonary Disease)B-PuReNCT07750821
Balance Training Following Pulmonary Rehabilitation on Balance in People With Chronic Obstructive Pulmonary Disease (COPD)
A study testing Sport4Steadiness in people with COPD (Chronic Obstructive Pulmonary Disease) and COPD, run by Samantha Harrison at 3 sites in United Kingdom.
Trial summary
This study aims to see if a co-designed balance training programme called Sport4Steadiness (S4S), is acceptable to people with COPD and if the study procedures, including recruitment and the collection of outcomes, is feasible. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), COPD, Balance Exercise
- What is being tested?
- Sport4Steadiness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 27 Jan 2026to 1 May 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults with spirometry confirmed diagnosis of COPD as per GOLD guidelines (FEV1/FVC ratio below 0.7) or physician confirmed COPD diagnosis
- Answers yes to one or more of the Three Key Questions* or Timed up and Go Test result > 11 seconds
- An ability and capacity to provide consent to the trial
- Q1. Have you fallen in the past year? Q2. Do you feel unsteady when standing or walking? Q3. Do you have worries about falling?
Who cannot join
- Any neurological, musculoskeletal, chronic pain or other diagnoses that, in the opinion of the investigator, would interfere with the ability of the participant to safely complete PR and balance training
- Unable to comprehend instruction given verbally in English language
- Where there is concern that the primary cause of balance issues could be due to problems with visual function, vestibular disturbance or peripheral neuropathy
- Diagnosis of, or patient-reported symptoms of, vasovagal syncope
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom3 sites, 3 recruiting
- Recruiting
Teesside University
Middlesbrough, TS1 3BX
Samantha Harrison, Professor, +1642738512, s.l.harrison@tees.ac.uk
Alexandra Carne-Watson, Dr, alex.carne-watson@nhs.net
- Recruiting
South Tees Hospital Trust
Northallerton, DL6 1JG
Kirsti Loughran, Dr, +7385086743, k.loughran@tees.ac.uk
Alexandra Carne-Watson, Dr, a.carne-watson@nhs.net
- Recruiting
North Tees and Hartlepool NHS Foundation Trust
Stockton-on-Tees, TS198PE
Kirsti Loughran, Dr, +7385086743, k.loughran@tees.ac.uk
Alexandra Carne-Watson, Dr, +7983536310, a.carne-watson@nhs.net
About this study
Official title: A Pilot Feasibility, Multi-centre, Randomised Controlled Trial of Balance Training Following Pulmonary Rehabilitation on Balance in People With Chronic Obstructive Pulmonary Disease (COPD)
This study aims to see if a co-designed balance training programme called Sport4Steadiness (S4S), is acceptable to people with COPD and if the study procedures, including recruitment and the collection of outcomes, is feasible.
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), COPD, Balance Exercise, Falls, Intervention, Balance Training, Pulmonary Rehabilitation
- Being tested
- Sport4Steadiness
- Keywords
- B-PuRe, Balance, Pulmonary rehabilitation, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sport4SteadinessOther
Sport4Steadiness (S4S), is a group, exercise based, balance training programme. It was designed by researchers interested in balance in people with COPD and patients and members of the public who have, or care for someone with, COPD or other lung conditions. It adapts parts of different sports, games and activities to train balance and have fun. S4S sessions take place twice a week for 6 weeks, 12 sessions in total. Each session lasts for 2 hours with 1 hour of activity and 1 hour of socialisation
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Participants randomised to this arm will continue with their home based exercise programme provided by pulmonary rehabilitation as part of usual care |
| Sport4Steadiness Programme | Experimental | A balance training programme post pulmonary rehabilitation Receives: Other: Sport4Steadiness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of study procedures and the delivery of S4S.
The primary feasibility outcomes include participant recruitment rates per site, participants' willingness to be randomised, participant attrition rates, and participant adherence rates.
Measured: Outcomes are assessed at the end of recruitment, post-randomisation, and approximately 12 weeks after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start27 Jan 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pilot feasibility, multi-centre, randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samantha Harrison
- Sponsor type
- University, hospital or other
- Collaborators
- North Tees and Hartlepool NHS Foundation Trust, South Tees Hospitals NHS Foundation Trust
- Responsible party
- Sponsor-investigator, Samantha Harrison, Teesside University
- Investigators
- Samantha Harrison, Professor, Principal investigator, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750821
- Sponsor's protocol ID
- 358711
- Other IDs
- 26932
- Acronym
- B-PuRe
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility, Multi-centre, Randomised Controlled Trial of Balance Training Following Pulmonary Rehabilitation on Balance in People With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT07750821
- Acronym / sponsor ID
- B-PuRe / 358711
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), COPD, Balance Exercise, Falls, Intervention, Balance Training, Pulmonary Rehabilitation
- Keywords
- B-PuRe, Balance, Pulmonary rehabilitation, COPD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Samantha HarrisonUniversity, hospital or other
- Collaborators
- North Tees and Hartlepool NHS Foundation Trust, South Tees Hospitals NHS Foundation Trust
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 6 Aug 2026 (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 study aims to see if a co-designed balance training programme called Sport4Steadiness (S4S), is acceptable to people with COPD and if the study procedures, including recruitment and the collection of outcomes, is feasible.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A pilot feasibility, multi-centre, randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Participants randomised to this arm will continue with their home based exercise programme provided by pulmonary rehabilitation as part of usual care |
| Sport4Steadiness Programme | Experimental | Other: Sport4SteadinessA balance training programme post pulmonary rehabilitation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Adults with spirometry confirmed diagnosis of COPD as per GOLD guidelines (FEV1/FVC ratio below 0.7) or physician confirmed COPD diagnosis
- Answers yes to one or more of the Three Key Questions* or Timed up and Go Test result > 11 seconds
- An ability and capacity to provide consent to the trial
Key exclusion criteria (4 listed)
- Any neurological, musculoskeletal, chronic pain or other diagnoses that, in the opinion of the investigator, would interfere with the ability of the participant to safely complete PR and balance training
- Unable to comprehend instruction given verbally in English language
- Where there is concern that the primary cause of balance issues could be due to problems with visual function, vestibular disturbance or peripheral neuropathy
- Diagnosis of, or patient-reported symptoms of, vasovagal syncope
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 |
|---|---|---|
| Sport4SteadinessSport4Steadiness (S4S), is a group, exercise based, balance training programme. It was designed by researchers interested in balance in people with COPD and patients and members of the public who have, or care for someone with, COPD or other lung conditions. It adapts parts of different sports, games and activities to train balance and have fun. S4S sessions take place twice a week for 6 weeks, 12 sessions in total. Each session lasts for 2 hours with 1 hour of activity and 1 hour of socialisation | Other | Sport4Steadiness Programme |
Primary outcome
Feasibility of study procedures and the delivery of S4S.
Time frame: Outcomes are assessed at the end of recruitment, post-randomisation, and approximately 12 weeks after baseline assessment
The primary feasibility outcomes include participant recruitment rates per site, participants' willingness to be randomised, participant attrition rates, and participant adherence rates.
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 14 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Samantha Harrison, Professor principal investigator
Teesside University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sport4Steadiness in people with COPD (Chronic Obstructive Pulmonary Disease) and COPD, run by Samantha Harrison at 3 sites 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 4 inclusion and 4 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 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Contact Samantha Harrison, Professor (+1642738512, s.l.harrison@tees.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of study procedures and the delivery of S4S. (time frame: Outcomes are assessed at the end of recruitment, post-randomisation, and approximately 12 weeks after baseline assessment). 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 14 Aug 2026.