Feasibility and Safety of Walking Football in Patients With Type 2 Diabetes
2019년 8월 20일 업데이트: Romeu Mendes, Universidade do Porto
Our main challenge is to develop a novel physical activity intervention to promote exercise participation sustainability and effective health benefits in type 2 diabetes (T2D) population with minimum health risks.
The relevance of this study is supported by four cornerstones: 1) The Portuguese love football and there seems to be a major potential in the implementation of football practice as part of the prevention and treatment of noncommunicable diseases for the middle-aged and elderly Portuguese population; 2) no studies have assessed the feasibility and safety of a walking football exercise program for middle-age and older patients with T2D; 3) the proposed investigation relies on robust methodology; 4) this intervention can have further sustainability with the enrollment of football clubs and primary health care units.
연구 개요
상세 설명
This work will be a quasi-experimental study where we aim to test the feasibility and safety of walking football in patients with T2D.
The recruitment of participants will be held in primary health care units by Family Medicine medical doctors.
All participants will receive instructions to maintain daily-life routines (lifestyle-related physical activity and dietary pattern), and to continue with usual care (diabetes consultations on primary health care units and pharmacological regimen) along the studies duration.
All participants will receive basic sports material (sports bag, T-shirt, and sports shoes).
Participants will be organized in two teams of 20 players.
Each team will have 60-min walking football exercise sessions three times per week (non-consecutive days), during three months (36 sessions).
Different walking football exercise strategies will be developed according to participants' motor skills and tested with dose-escalated intensity for its safety (acute effects on capillary glycaemia, blood pressure, foot impact, exercise-related injuries and adverse events) and enjoyment.
Exercise intensity will range between light to vigorous.
No submaximal or maximal exercises will be tested.
Cumulative short-term effects will also be analyzed along the three months through pre- and post-study evaluations.
Exercise sessions will be conducted on a sports hall (indoor court) by a football coach and supervised by an exercise physiologist and a nurse.
연구 유형
중재적
등록 (실제)
40
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Porto, 포르투갈, 4050-600
- Instituto de Saude Publica da Universidade do Porto
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
50년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
남성
설명
Inclusion Criteria:
- diagnosis of type 2 diabetes for at least 12 months;
- glycated hemoglobin bellow 10 %;
- not having started insulin therapy in the previous six months;
- not having started therapy with sulfonylureas in the previous six months;
- major complications of diabetes screened and controlled (diabetic retinopathy, diabetic nephropathy and diabetic foot);
- no symptoms of coronary artery disease;
- no cardiovascular, respiratory and musculoskeletal contraindications to exercise;
- not under cancer treatment (radiotherapy or intravenous chemotherapy);
- without limitations in gait or balance;
- independent living in the community;
- not engaged in supervised exercise;
- non-smokers at least for 6 months.
Exclusion Criteria:
- cardiological stress test with cardiac or hemodynamic problems
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Exercise
Walking football exercise program
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Participants will be organized in two teams of 20 players.
Each team will have 60-min walking football exercise sessions three times per week (non-consecutive days), during three months (36 sessions).
Different walking football exercise strategies will be developed according to participants' motor skills and tested with dose-escalated intensity for its safety and enjoyment.
Exercise intensity will range between light to vigorous.
No submaximal or maximal exercises will be tested.
Exercise sessions will be conducted on a sports hall (indoor court) by a football coach and supervised by an exercise physiologist and a nurse.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Exercise intensity - subjective internal load
기간: Through 3 months
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OMNI rating of perceived exertion scale during exercise (0 [lowest] to 10 [highest] points)
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Through 3 months
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Exercise intensity - objective internal load
기간: Through 3 months
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Heart rate during exercise
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Through 3 months
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Exercise intensity - external load
기간: Through 3 months
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Distance (km) assessed using GPS tracking during exercise
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Through 3 months
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Acute glycemic effect
기간: Change between before and immediately after each exercise session
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Acute change in capillary blood glucose with exercise sessions
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Change between before and immediately after each exercise session
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Acute systolic blood pressure effect
기간: Change between before and immediately after each exercise session
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Acute change in systolic blood pressure with exercise sessions
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Change between before and immediately after each exercise session
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Acute diastolic blood pressure effect
기간: Change between before and immediately after each exercise session
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Acute change in diastolic blood pressure with exercise sessions
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Change between before and immediately after each exercise session
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Incidence of falls
기간: Through 3 months
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Number of falls during the exercise program
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Through 3 months
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Incidence of foot injuries
기간: Through 3 months
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Number of reported foot injuries during the exercise program
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Through 3 months
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Incidence of musculoskeletal injuries
기간: Through 3 months
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Number of reported musculoskeletal injuries during the exercise program
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Through 3 months
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Rate of Enjoyment
기간: Through 3 months
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Self-reported exercise sessions' enjoyment on a likert scale (1 [lowest] to 5 [highest] points)
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Through 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Glycemic control
기간: Change from baseline to 3 months
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Glycated hemoglobin (venous blood analysis)
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Change from baseline to 3 months
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Blood lipid profile
기간: Change from baseline to 3 months
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Total cholesterol (venous blood analysis)
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Change from baseline to 3 months
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Clinical systolic blood pressure
기간: Change from baseline to 3 months
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Resting systolic blood pressure
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Change from baseline to 3 months
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Clinical diastolic blood pressure
기간: Change from baseline to 3 months
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Resting diastolic blood pressure
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Change from baseline to 3 months
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Body mass index
기간: Change from baseline to 3 months
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Body mass index
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Change from baseline to 3 months
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Waist circumference
기간: Change from baseline to 3 months
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Waist circumference
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Change from baseline to 3 months
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Body fat
기간: Change from baseline to 3 months
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Body fat (bioelectrical impedance analysis)
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Change from baseline to 3 months
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Body lean mass
기간: Change from baseline to 3 months
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Body lean mass (bioelectrical impedance analysis)
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Change from baseline to 3 months
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Agility/balance
기간: Change from baseline to 3 months
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Timed Up and Go Test
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Change from baseline to 3 months
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Habitual physical activity
기간: Change from baseline to 3 months
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Global Physical Activity Questionnaire
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Change from baseline to 3 months
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Food pattern
기간: Change from baseline to 3 months
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24h-food recall analysis
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Change from baseline to 3 months
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Cognitive state
기간: Change from baseline to 3 months
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Montreal Cognitive Assessment score (0 [lowest] to 30 [highest] points)
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Change from baseline to 3 months
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Health-related quality of life
기간: Change from baseline to 3 months
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EQ-5D-5L questionnaire score (0 [lowest] to 100 [highest] points)
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Change from baseline to 3 months
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Medication
기간: Change from baseline to 3 months
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Number of medications
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Change from baseline to 3 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Romeu Mendes, MD, PhD, EPIUnit - Instituto de Saúde Pública, Universidade do Porto
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Barbosa A, Brito J, Costa J, Ramos E, Firmino-Machado J, Seabra A, Figueiredo P, Sá MJ, Lunet N, Mendes R. SWEET-FOOTBALL: Development of an evidence-based walking football program for middle-aged and older patients with type 2 diabetes. Football is Medicine Conference 2019 - Programme and Abstracts. Odense: University of Southern Denmark; 2019. p. 32.
- Barbosa A, Brito J, Sá MJ, Puga F, Firmino-Machado J, Seabra A, Figueiredo P, Ramos E, Lunet N, Mendes R. Adherence and enjoyment of a walking-football program for patients with type 2 diabetes: SWEET-FOOTBALL Project. In: Bunc V, Tsolakidis E, editors. Book of Abstracts of the 24th Annual Congress of the European College of Sport Science. Prague: ECSS; 2019. p. 120-1.
- Rago V, Brito J, Costa J, Barbosa A, Figueiredo P, Seabra A, Travassos B, Mendes R. Activity profile during walking football training sessions in patients with type 2 diabetes. Football is Medicine Conference 2019 - Programme and Abstracts. Odense: University of Southern University; 2019. p. 41.
- Costa J, Brito J, Barbosa A, Figueiredo P, Seabra A, Sá MJ, Firmino-Machado J, Ramos E, Mendes R. Nocturnal cardiac autonomic activity in patients with type 2 diabetes engaged in a walking football programme. Football is Medicine Conference 2019 - Programme and Abstracts. Odense: University of Southern Denmark; 2019. p. 39.
- Barbosa A, Brito J, Costa J, Figueiredo P, Seabra A, Mendes R. Feasibility and safety of a walking football program in middle-aged and older men with type 2 diabetes. Prog Cardiovasc Dis. 2020 Nov-Dec;63(6):786-791. doi: 10.1016/j.pcad.2020.06.014. Epub 2020 Jul 4.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 9월 17일
기본 완료 (실제)
2019년 1월 31일
연구 완료 (실제)
2019년 6월 30일
연구 등록 날짜
최초 제출
2019년 1월 10일
QC 기준을 충족하는 최초 제출
2019년 1월 16일
처음 게시됨 (실제)
2019년 1월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 8월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 8월 20일
마지막으로 확인됨
2019년 8월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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