A Feasibility Study of Physical Activity After Surgical or Catheterization Intervention
A legfontosabb adatok
- Ki végzi
- Children's Hospital of Eastern Ontario
- Hol
- Kanada1 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Befejeződött
- Résztvevők
- 43 fő vett részt
- Kezdés
- 2020. nov. 1.
- Befejezés
- 2025. okt. 31.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoport
- A vizsgált kezelések
- Individualized Home and Play-Based Physical Activity Plans
- A regiszteradat frissítve
- 2026. március 17.
Ki vehet részt
- Életkor
- 3 hónap – 72 hónap
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 6 feltétel megnézéseKevesebb
Ki vehet részt
- Female or male at least 3 months of age but not more than 72 months of age (upper age limit for valid Peabody Motor Development Scales-2 assessment)
- Receiving elective treatment via cardiac surgery or catheterization intervention for CHD at the Children's Hospital of Eastern Ontario
Ki nem vehet részt
- Genetic conditions or physical disabilities impacting motor development (e.g., Down syndrome)
- Emergency treatment for child in critical condition
- Medical care not compatible with study assessments
- No independent limb movement
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A vizsgálatról
Mit akar kideríteni a vizsgálat
This feasibility study will assess whether a 6-month, home-based, parent-led physical activity program, completed after surgical or catheterization treatment, enables young children with congenital heart defects (CHD) to achieve the recommended 180 minutes of daily physical activity. This study includes comprehensive measures of motor skill and physical activity, intervening at a very young age, and targeting the high risk status for sedentary lifestyles of children with CHD. This study will provide essential data on patient recruitment, data collection procedures, the proposed physical activity intervention and resources required to enable the design of a randomized controlled trial (RCT) to evaluate play-based, parent-delivered interventions optimized to support age-appropriate physical activity and motor skills among young children with CHD.
A vizsgálat 2 csoportja
- Intervention GroupA vizsgált kezelés
All children enrolled in the study will complete five study visits. All participants will complete all outcome measures (including surveys, questionnaires, and motor skill assessments) at or after each 1-hour assessment visit. Children will be given an omni-directional accelerometer to wear on a waist-worn belt for 7 days after each visit to assess daily physical activity. The intervention group will complete individualized, parent-led, home and play-based activity plans for 6 months, beginning as soon as the child returns to the inpatient unit. The activities in the plan will be tailored to each phase of treatment (in hospital, discharge to week 7, week 8 to 6 months), follow a standardized format and provide content individualized to each child's age and previous visit assessments.
Kezelés: Individualized Home and Play-Based Physical Activity Plans
- Wait List Control GroupA vizsgált kezelés
All children enrolled in the study will complete five study visits. After the first visit is complete, children will be randomized to either the intervention or wait-list control study group. Control participants will follow the same schedule of assessments at each visit, but the intervention will be provided between the 12-month and 16-month assessments. All participants will complete all outcome measures (including surveys, questionnaires, and motor skill assessments) at or after each 1-hour assessment visit. Children will be given an omni-directional accelerometer to wear on a waist-worn belt for 7 days after each visit to assess daily physical activity.
Kezelés: Individualized Home and Play-Based Physical Activity Plans
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Preventing Sedentary Lifestyles Among Children Born With Congenital Heart Defects; A Feasibility Study of Physical Activity After Surgical or Catheterization Intervention
- Publikációk
- A regiszteradat frissítve
- 2026. március 17.