NCT05575102

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

March 22, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2023

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

October 7, 2022

Last Update Submit

April 9, 2024

Conditions

Keywords

DyspneaChronic BreathlessnessFootballWalkingExercisePhysical ActivityPulmonary RehabilitationFeasibilityChronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (4)

  • Recruitment and Consent Rate

    Percentage of eligible participants given an information sheet who consent to participate

    6-Months

  • Completion Rate

    Percentage of participants who complete at least four of the available six sessions

    6-Weeks

  • Methodology and Intervention Acceptability

    Percentage of participants who complete all pre-post outcome measurements, intensity outcome measurements, and partake in an interview.

    10-Weeks

  • Adverse Events

    Number of Serious and Minor Adverse Events recorded

    6-Weeks

Study Arms (1)

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.

Other: Walking Football

Interventions

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.

Walking Football

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tesside University

Middlesbrough, United Kingdom

Location

MeSH Terms

Conditions

DyspneaMotor ActivityPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorLung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic Processes

Study Officials

  • Samantha Harrison

    Teesside University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Respiratory Rehabilitation

Study Record Dates

First Submitted

October 7, 2022

First Posted

October 12, 2022

Study Start

March 22, 2023

Primary Completion

June 29, 2023

Study Completion

December 13, 2023

Last Updated

April 10, 2024

Record last verified: 2024-04

Locations