Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT05575102
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2022-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Walking Football for People With Chronic Breathlessness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-09', 'studyFirstSubmitDate': '2022-10-07', 'studyFirstSubmitQcDate': '2022-10-07', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment and Consent Rate', 'timeFrame': '6-Months', 'description': 'Percentage of eligible participants given an information sheet who consent to participate'}, {'measure': 'Completion Rate', 'timeFrame': '6-Weeks', 'description': 'Percentage of participants who complete at least four of the available six sessions'}, {'measure': 'Methodology and Intervention Acceptability', 'timeFrame': '10-Weeks', 'description': 'Percentage of participants who complete all pre-post outcome measurements, intensity outcome measurements, and partake in an interview.'}, {'measure': 'Adverse Events', 'timeFrame': '6-Weeks', 'description': 'Number of Serious and Minor Adverse Events recorded'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dyspnea', 'Chronic Breathlessness', 'Football', 'Walking', 'Exercise', 'Physical Activity', 'Pulmonary Rehabilitation', 'Feasibility', 'Chronic Obstructive Pulmonary Disease'], 'conditions': ['Dyspnea']}, 'descriptionModule': {'briefSummary': "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.\n\nThis 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.\n\nPR 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.\n\nParticipants 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.\n\nDuring 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of chronic breathlessness via a chronic respiratory condition (through referral to PR)\n\n * 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).\n* Be 35 years or over at the point of recruitment\n* Scheduled PR programme ends within the recruitment window\n* Be able to communicate with good verbal English or use adaptive equipment to communicate\n* Respiratory condition is stable (e.g. six weeks clear of exacerbation in COPD)\n\nExclusion Criteria:\n\n* Unstable Angina\n* Other conditions that may affect balance (e.g. neurological)\n* Recent exacerbation of COPD (within the last six weeks)\n* Unable to provide written informed consent\n* Unable to speak English or no translation options available\n* Any other acute health conditions that would make activity unsafe e.g. acute infection'}, 'identificationModule': {'nctId': 'NCT05575102', 'briefTitle': 'Walking Football for People With Chronic Breathlessness', 'organization': {'class': 'OTHER', 'fullName': 'Teesside University'}, 'officialTitle': 'Walking Football for People With Chronic Breathlessness: a Mixed-methods Feasibility Study', 'orgStudyIdInfo': {'id': '10814'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Walking Football', '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.', 'interventionNames': ['Other: Walking Football']}], 'interventions': [{'name': 'Walking Football', 'type': 'OTHER', 'description': 'Walking Football (Soccer): Typical football rules apply but without running.\n\nParticipants 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.', 'armGroupLabels': ['Walking Football']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Middlesbrough', 'country': 'United Kingdom', 'facility': 'Tesside University', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}], 'overallOfficials': [{'name': 'Samantha Harrison', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Teesside University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teesside University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Respiratory Rehabilitation', 'investigatorFullName': 'Samantha Harrison', 'investigatorAffiliation': 'Teesside University'}}}}