- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Pennsylvania
-
Hershey, Pennsylvania, Förenta staterna, 17033
- Penn State Hershey Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
Play modified games with other adults three times a week for 12 weeks.
Complete a brief survey on the games played and program satisfaction.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Compare exercise intensity, METS (Metabolic Equivalent Task)
Tidsram: 12 weeks
|
METS will be measured during each exercise session using an accelerometer (ActiGraph GT3X).
|
12 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Self-reported weight
Tidsram: 12 weeks
|
Self-reported weight will be captured by a research assistant at baseline and follow up (12 week) visits.
|
12 weeks
|
Self-reported height
Tidsram: 12 weeks
|
Self-reported height will be captured by a research assistant at baseline and follow up (12 week) visits.
|
12 weeks
|
Gender
Tidsram: 12 weeks
|
Participants will be asked if they are male or female.
|
12 weeks
|
Self-reported chronic conditions
Tidsram: 12 weeks
|
Participants will be asked 4 questions on which chronic conditions (if any) they may have.
|
12 weeks
|
Ethnicity
Tidsram: 12 weeks
|
Participants will be asked what their ethnicity is.
|
12 weeks
|
Race
Tidsram: 12 weeks
|
Participants will be asked what their race is.
|
12 weeks
|
Education Level
Tidsram: 12 weeks
|
Participants will be asked 1 question on education level.
|
12 weeks
|
Employment Status
Tidsram: 12 weeks
|
Participants will be asked 1 question on employment status.
|
12 weeks
|
Tobacco Use
Tidsram: 12 weeks
|
Participants will be asked 1 question on tobacco use.
|
12 weeks
|
National Health Interview Survey
Tidsram: 12 weeks
|
Participants will be asked 2 questions from this survey on how difficult it is to walk and carry an item.
|
12 weeks
|
General Self Rated Health
Tidsram: 12 weeks
|
Participants will be asked 1 question on their overall health.
|
12 weeks
|
Three Item Loneliness Scale
Tidsram: 12 weeks
|
Participants will be asked 3 questions on feelings of being lonely.
|
12 weeks
|
Patient Reported Outcomes (PROMIS) - Anxiety
Tidsram: 12 weeks
|
Participants will be asked questions 4 questions on anxiety.
|
12 weeks
|
Patient Reported Outcomes (PROMIS) - Depression
Tidsram: 12 weeks
|
Participants will be asked 4 questions on Depression.
|
12 weeks
|
Patient Reported Outcomes (PROMIS) - Physical Function
Tidsram: 12 weeks
|
Participants will be asked 4 questions on physical function.
|
12 weeks
|
Sport playing status
Tidsram: 12 weeks
|
Participants will be asked 2 questions on playing sports previously.
|
12 weeks
|
Program Intensity Survey
Tidsram: 12 weeks
|
Participants will be asked 2 questions after each game session on how physically and technically hard the game was.
|
12 weeks
|
Program Satisfaction Survey
Tidsram: 12 weeks
|
Participants will be asked 2 questions after each game session on what they did and did not like about the game.
|
12 weeks
|
Net Promoter Score
Tidsram: 12 weeks
|
Participants will be asked 1 question on how likely they would recommend the day's activity/game to a friend or family member.
|
12 weeks
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 4785
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