Walking Football for People With Chronic Breathlessness
Primary Purpose
Dyspnea
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Walking Football
Sponsored by
About this trial
This is an interventional basic science trial for Dyspnea focused on measuring Dyspnea, Chronic Breathlessness, Football, Walking, Exercise, Physical Activity, Pulmonary Rehabilitation, Feasibility, Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
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 18 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)
Exclusion Criteria:
- 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
Sites / Locations
- Tesside UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Walking Football
Arm Description
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.
Outcomes
Primary Outcome Measures
Recruitment and Consent Rate
Percentage of eligible participants given an information sheet who consent to participate
Completion Rate
Percentage of participants who complete at least four of the available six sessions
Methodology and Intervention Acceptability
Percentage of participants who complete all pre-post outcome measurements, intensity outcome measurements, and partake in an interview.
Adverse Events
Number of Serious and Minor Adverse Events recorded
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05575102
Brief Title
Walking Football for People With Chronic Breathlessness
Official Title
Walking Football for People With Chronic Breathlessness: a Mixed-methods Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Teesside University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea
Keywords
Dyspnea, Chronic Breathlessness, Football, Walking, Exercise, Physical Activity, Pulmonary Rehabilitation, Feasibility, Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Walking Football
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Walking Football
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment and Consent Rate
Description
Percentage of eligible participants given an information sheet who consent to participate
Time Frame
6-Months
Title
Completion Rate
Description
Percentage of participants who complete at least four of the available six sessions
Time Frame
6-Weeks
Title
Methodology and Intervention Acceptability
Description
Percentage of participants who complete all pre-post outcome measurements, intensity outcome measurements, and partake in an interview.
Time Frame
10-Weeks
Title
Adverse Events
Description
Number of Serious and Minor Adverse Events recorded
Time Frame
6-Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samantha Harrison
Phone
01325 738412
Email
S.L.Harrison@tees.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Callum Bradford
Phone
01325 738412
Email
c.bradford@tees.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samantha Harrison
Organizational Affiliation
Teesside University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tesside University
City
Middlesbrough
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Callum Bradford
Email
c.bradford@tees.ac.uk
12. IPD Sharing Statement
Learn more about this trial
Walking Football for People With Chronic Breathlessness
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