DyspneaNCT05575102
Walking Football for People With Chronic Breathlessness
A study testing Walking Football in people with Dyspnea, run by Teesside University at 1 site in United Kingdom.
Trial summary
The objective of this study is to evaluate the feasibility of a walking football intervention for people with chronic breathlessness. Chronic breathlessness refers to breathlessness that persists despite optimal treatment of the underlying pathophysiology. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Dyspnea
- What is being tested?
- Walking Football
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Mar 2023to 13 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of chronic breathlessness via a chronic respiratory condition (through referral to PR)
- Example conditions include; COPD, severe asthma, Pulmonary Fibrosis, Lung Disease (This does not include Long Covid as many patients often make a full recovery over time).
- Be 35 years or over at the point of recruitment
- Scheduled PR programme ends within the recruitment window
- Be able to communicate with good verbal English or use adaptive equipment to communicate
- Respiratory condition is stable (e.g. six weeks clear of exacerbation in COPD)
Who cannot join
- Unstable Angina
- Other conditions that may affect balance (e.g. neurological)
- Recent exacerbation of COPD (within the last six weeks)
- Unable to provide written informed consent
- Unable to speak English or no translation options available
- Any other acute health conditions that would make activity unsafe e.g. acute infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Walking Football for People With Chronic Breathlessness: a Mixed-methods Feasibility Study
The objective of this study is to evaluate the feasibility of a walking football intervention for people with chronic breathlessness. Chronic breathlessness refers to breathlessness that persists despite optimal treatment of the underlying pathophysiology. Roughly 9-13% of the general population will experience chronic breathlessness, with incidence rising with age to 37% for those aged over 60years.
This mixed-methods study will offer patients who have enrolled on to pulmonary rehabilitation (PR) the prospect to partake in walking football once they have completed their scheduled programmes (or voluntarily dropped-out); introducing a potential opportunity for long-term exercise maintenance post PR. Participants will be recruited from North Tees \& Hartlepool Foundation Trust, and South Tees Foundation Trust.
Read more
PR is recommended for all people with chronic breathlessness and has been shown to improve exercise capacity and health-related quality of life. However, PR programmes typically only last for 6-12 weeks, and have little to no impact on long-term physical activity levels. Walking Football has been identified as a potential form of exercise which people with breathlessness could maintain post-PR, thus offering a solution to PRs limited ability to promote exercise maintenance.
Participants will be invited to play walking football for 6-weeks (2-hours weekly) in the Middlesbrough/Stockton area. Before and after weeks 1 and 6, breathlessness-relevant outcomes will be measured including; exercise capacity, lower-limb strength, perceived breathlessness, quality of life, balance confidence, depression, and anxiety.
During a participant's third session, one-time physical intensity outcomes will be calculated during play including heart-rate and perceived intensity. Participants will also be invited to an interview to discuss how feasible they have found the football, any benefits they may have experienced, and how the football programme could be improved.
The study will officially end with a co-production workshop; a focus group with stakeholders (players, physiotherapists, co-ordinators, researchers) after preliminary analysis has been conducted to discuss initial findings.
- Conditions
- Dyspnea
- Being tested
- Walking Football
- Keywords
- Dyspnea, Chronic Breathlessness, Football, Walking, Exercise, Physical Activity, Pulmonary Rehabilitation, Feasibility, Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Dyspnea, Motor Activity, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking FootballOther
Walking Football (Soccer): Typical football rules apply but without running.
Participants will play at a local sports hall for 6-weeks, (2-hour per week). Time will be split between warm-up, football practice drills, and small-sided games.
| Study group | Role | What they receive |
|---|---|---|
| Walking Football | Experimental | Walking football intervention for 6-weeks (2-hour per week) at a local sports hall, supervised by a walking football coach with assistance from CB. Receives: Other: Walking Football |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment and Consent Rate
Percentage of eligible participants given an information sheet who consent to participate
Measured: 6-Months
Completion Rate
Percentage of participants who complete at least four of the available six sessions
Measured: 6-Weeks
Methodology and Intervention Acceptability
Percentage of participants who complete all pre-post outcome measurements, intensity outcome measurements, and partake in an interview.
Measured: 10-Weeks
Adverse Events
Number of Serious and Minor Adverse Events recorded
Measured: 6-Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start22 Mar 2023
- Primary completion29 Jun 2023
- Study completion13 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samantha Harrison, Teesside University
- Investigators
- Samantha Harrison, Principal investigator, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575102
- Sponsor's protocol ID
- 10814
- Status last verified
- Apr 2024
- First submitted
- 7 Oct 2022
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walking Football for People With Chronic Breathlessness: a Mixed-methods Feasibility Study
- ClinicalTrials.gov ID
- NCT05575102
- Acronym / sponsor ID
- 10814
- Conditions
- Dyspnea
- Keywords
- Dyspnea, Chronic Breathlessness, Football, Walking, Exercise, Physical Activity, Pulmonary Rehabilitation, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 12 Oct 2022 (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.
The objective of this study is to evaluate the feasibility of a walking football intervention for people with chronic breathlessness. Chronic breathlessness refers to breathlessness that persists despite optimal treatment of the underlying pathophysiology. Roughly 9-13% of the general population will experience chronic breathlessness, with incidence rising with age to 37% for those aged over 60years.
This mixed-methods study will offer patients who have enrolled on to pulmonary rehabilitation (PR) the prospect to partake in walking football once they have completed their scheduled programmes (or voluntarily dropped-out); introducing a potential opportunity for long-term exercise maintenance post PR. Participants will be recruited from North Tees \& Hartlepool Foundation Trust, and South Tees Foundation Trust.
PR is recommended for all people with chronic breathlessness and has been shown to improve exercise capacity and health-related quality of life. However, PR programmes typically only last for 6-12 weeks, and have little to no impact on long-term physical activity levels. Walking Football has been identified as a potential form of exercise which people with breathlessness could maintain post-PR, thus offering a solution to PRs limited ability to promote exercise maintenance.
Participants will be invited to play walking football for 6-weeks (2-hours weekly) in the Middlesbrough/Stockton area. Before and after weeks 1 and 6, breathlessness-relevant outcomes will be measured including; exercise capacity, lower-limb strength, perceived breathlessness, quality of life, balance confidence, depression, and anxiety.
During a participant's third session, one-time physical intensity outcomes will be calculated during play including heart-rate and perceived intensity. Participants will also be invited to an interview to discuss how feasible they have found the football, any benefits they may have experienced, and how the football programme could be improved.
The study will officially end with a co-production workshop; a focus group with stakeholders (players, physiotherapists, co-ordinators, researchers) after preliminary analysis has been conducted to discuss initial findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Walking Football | Experimental | Other: Walking FootballWalking football intervention for 6-weeks (2-hour per week) at a local sports hall, supervised by a walking football coach with assistance from CB. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed diagnosis of chronic breathlessness via a chronic respiratory condition (through referral to PR)
- Be 35 years or over at the point of recruitment
- Scheduled PR programme ends within the recruitment window
- Be able to communicate with good verbal English or use adaptive equipment to communicate
- Respiratory condition is stable (e.g. six weeks clear of exacerbation in COPD)
Key exclusion criteria (6 listed)
- Unstable Angina
- Other conditions that may affect balance (e.g. neurological)
- Recent exacerbation of COPD (within the last six weeks)
- Unable to provide written informed consent
- Unable to speak English or no translation options available
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 |
|---|---|---|
| Walking FootballWalking Football (Soccer): Typical football rules apply but without running. Participants will play at a local sports hall for 6-weeks, (2-hour per week). Time will be split between warm-up, football practice drills, and small-sided games. | Other | Walking Football |
Primary outcome
Recruitment and Consent Rate
Time frame: 6-Months
Percentage of eligible participants given an information sheet who consent to participate
Completion Rate
Time frame: 6-Weeks
Percentage of participants who complete at least four of the available six sessions
Methodology and Intervention Acceptability
Time frame: 10-Weeks
Percentage of participants who complete all pre-post outcome measurements, intensity outcome measurements, and partake in an interview.
Adverse Events
Time frame: 6-Weeks
Number of Serious and Minor Adverse Events recorded
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
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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. This study is not recruiting at the moment.
Samantha Harrison principal investigator
Teesside University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking Football in people with Dyspnea, run by Teesside University 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 10 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and Consent Rate (time frame: 6-Months). The study lists 4 primary outcomes in all. 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 10 Apr 2024.