- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02944370
PlayFit Pilot: Encouraging Social Physical Play in the Community
The investigator is pilot testing the feasibility and impact of a low-cost intervention that uses existing gymnasiums, and therefore has the potential to be replicated across the United States. The intervention, PlayFit, is designed for adults aged 21-50. PlayFit has five key components, intended to overcome the major barriers to physical activity. First, it will assist people in finding others to play with, using the Pick-Up model of designating times to play and making those times known in the community. Second, it will overcome a lack of confidence in physical activity by including games of lower intensity for relatively unfit adults, then building up to moderate and vigorous games. Third, it will require team members of varying ages and genders to encourage intergenerational play. Fourth, it will use modified equipment (e.g., softer, lighter balls) and smaller game space to require less running, so that even relatively unfit people can feel confident participating. Fifth, it will be designed to be led by community volunteers, which will increase its disseminability.
AIM - Understand the optimum design for PlayFit. To meet this aim, the investigators will come up with a list of games to play and pilot the games at a gymnasium. The investigators will observe the participants playing the games and have them complete a brief survey.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Pennsylvania
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Hershey, Pennsylvania, 미국, 17033
- Penn State Hershey Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age 21-50
- Fluently read and speak English
- Current member of Hershey Medical Center's University Fitness Center OR willing to become a member
- Currently exercises < 150 minutes per week
Exclusion Criteria:
- Has been told by a doctor they a heart condition and should only do exercise recommended by a doctor
- Currently pregnant or planning to become pregnant in the next 6 months
- Planning to move out of the area in the next 6 months
- Has pain in chest, neck, jaw, or arms at rest, during daily activities of living
- Has experienced a forceful or rapid heart rate
- Has experience unreasonable breathlessness
- Has experienced dizziness fainting or blackouts
- Has experienced ankle swelling
- Has burning or cramping sensation in lower legs when walking short distances
- Has been told by a health professional not to exercise OR exercise only when supervised by a professional
- Has been diagnosed with diabetes
- Has been told by a doctor, nurse or health professional that they have (1) Weak or failing kidneys, (2) A heart attack/ myocardial infarction, (3) Angina or coronary heart disease, (4) A stroke, or (5) Any other kind of heart condition or heart disease - e.g. heart valve problem/aortic regurgitation (do not include heart murmur)
공부 계획
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 |
---|---|
실험적: PlayFit, Modified exercise games
Subjects will participate in three 60 minute game sessions each week for 12 weeks.
During each game session, subjects will be divided randomly into two teams to play a modified game.
Research staff will review the instructions of the game and if needed, modify the game rules during play to enhance the experience (ie.
keep it fun, keep it to moderate intensity level).
The length of play session between breaks increases each week.
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Play modified games with other adults three times a week for 12 weeks.
Complete a brief survey on the games played and program satisfaction.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Compare exercise intensity, METS (Metabolic Equivalent Task)
기간: 12 weeks
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METS will be measured during each exercise session using an accelerometer (ActiGraph GT3X).
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12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Self-reported weight
기간: 12 weeks
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Self-reported weight will be captured by a research assistant at baseline and follow up (12 week) visits.
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12 weeks
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Self-reported height
기간: 12 weeks
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Self-reported height will be captured by a research assistant at baseline and follow up (12 week) visits.
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12 weeks
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Gender
기간: 12 weeks
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Participants will be asked if they are male or female.
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12 weeks
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Self-reported chronic conditions
기간: 12 weeks
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Participants will be asked 4 questions on which chronic conditions (if any) they may have.
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12 weeks
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Ethnicity
기간: 12 weeks
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Participants will be asked what their ethnicity is.
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12 weeks
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Race
기간: 12 weeks
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Participants will be asked what their race is.
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12 weeks
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Education Level
기간: 12 weeks
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Participants will be asked 1 question on education level.
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12 weeks
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Employment Status
기간: 12 weeks
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Participants will be asked 1 question on employment status.
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12 weeks
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Tobacco Use
기간: 12 weeks
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Participants will be asked 1 question on tobacco use.
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12 weeks
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National Health Interview Survey
기간: 12 weeks
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Participants will be asked 2 questions from this survey on how difficult it is to walk and carry an item.
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12 weeks
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General Self Rated Health
기간: 12 weeks
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Participants will be asked 1 question on their overall health.
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12 weeks
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Three Item Loneliness Scale
기간: 12 weeks
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Participants will be asked 3 questions on feelings of being lonely.
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12 weeks
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Patient Reported Outcomes (PROMIS) - Anxiety
기간: 12 weeks
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Participants will be asked questions 4 questions on anxiety.
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12 weeks
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Patient Reported Outcomes (PROMIS) - Depression
기간: 12 weeks
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Participants will be asked 4 questions on Depression.
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12 weeks
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Patient Reported Outcomes (PROMIS) - Physical Function
기간: 12 weeks
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Participants will be asked 4 questions on physical function.
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12 weeks
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Sport playing status
기간: 12 weeks
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Participants will be asked 2 questions on playing sports previously.
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12 weeks
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Program Intensity Survey
기간: 12 weeks
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Participants will be asked 2 questions after each game session on how physically and technically hard the game was.
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12 weeks
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Program Satisfaction Survey
기간: 12 weeks
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Participants will be asked 2 questions after each game session on what they did and did not like about the game.
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12 weeks
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Net Promoter Score
기간: 12 weeks
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Participants will be asked 1 question on how likely they would recommend the day's activity/game to a friend or family member.
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12 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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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