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Идёт набор NCT06777394

Effects of High Intensity Interval Training in Down Syndrome

Без фазы С лечением Down Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: High intensity interval training, Routine treatmet.
Кому может быть актуально
Состояния в реестре: Down Syndrome. Базовые параметры: 3 лет — 14 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Пакистан
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effects of High Intensity Interval Training on Endurance and Trunk Stability in Children With Down Syndrome

Обзор

Down Syndrome (DS), a genetic condition marked by the presence of an extra chromosome 21, is associated with various cognitive and physical challenges. Children with DS often experience motor development issues, including reduced endurance and decreased trunk stability, which underscores the need for targeted interventions. Common impairments in individuals with DS include hypotonia, ligament laxity, reduced muscle strength, limited muscle co-contraction, poor postural control, and impaired proprioception. This study is driven by a lack of research on the effects of High-Intensity Interval Training (HIIT) in this population, despite its documented benefits in enhancing cardiovascular fitness across other groups. Existing literature supports the benefits of exercise interventions for people with DS, but the application and advantages of HIIT-particularly concerning endurance and trunk stability-are underexplored.

Подробное описание

The study aims to evaluate the impact of a structured HIIT program on endurance and trunk stability in children with DS. Conducted as a randomized controlled trial (RCT) at Khuwaja Arshad Hospital, Sargodha, the study will include 30 participants divided equally and randomly assigned to two groups. The inclusion criteria include children with a confirmed DS diagnosis, aged 3 to 14, with the ability to understand instructions, stand, and walk independently, and of any gender. Exclusion criteria include mobility impairments, signs of atlantoaxial joint instability, and neurological conditions. Group A will participate in a HIIT program, while Group B will receive routine physical therapy. Pre- and post-intervention assessments will use validated tools to measure endurance (6-Minute Walk Test) and trunk stability (Functional Reach Test). Additionally, the feasibility and acceptability of the HIIT program will be qualitatively evaluated. Data will be collected at baseline and post-intervention and analyzed using SPSS version 23.Data analysis will be conducted using SPSS software. Quantitative data will be reported as mean and standard deviation and visualized with histograms, while qualitative data will be summarized as frequency and percentage and displayed using bar charts. Statistical techniques will be applied to compare baseline characteristics between groups and to assess normal distribution through the Four Square Step Test, the Six-Minute Walk Test for endurance, and the Functional Reach Test for trunk stability. If data follow a normal distribution, within-group differences will be analyzed using a paired sample t-test; otherwise, the Wilcoxon Signed Rank test, a non-parametric alternative, will be applied. For between-group differences, an independent sample t-test will be used for normally distributed data, while the Mann-Whitney U test will be used for non-normally distributed data. A 95% confidence interval and a significance level of p \< 0.05 will be considered significant.

Вмешательства

  • Другое High intensity interval training
    The HIIT program begins with a warm-up, followed by high-intensity repetitions separated by moderate-intensity recovery intervals. High-intensity exercises are performed near maximum effort, while moderate-intensity periods are maintained at 50% effort. HIIT exercises, involving low-skill movements in short bursts, enhance blood sugar regulation and fat-burning capacity. The HIIT protocol has four phases: Warm-Up: 10 minutes, gradually increasing to about 60% of maximum heart rate. Intervals:
  • Другое Routine treatmet
    outine physical therapy includes stretching exercises, exercises to maintain a normal range of motion, and low-intensity and aerobic exercises for the patients. Low-Intensity Exercise: The effects of low-intensity exercise become noticeable after about 20 minutes, providing a metabolic boost during the activity. Generally, a longer exercise duration further enhances metabolism.

Первичные конечные точки

  • Four square balance test [Срок оценки: 6 weeks]
Вторичные конечные точки (1)
  • 6 minutes walk test for endurance [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

  • Age group between 3 to 14 years
  • clinically diagnose in children with down syndrome

Критерии исключения

  • Any neurological condition
  • History of dementia

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Пакистан · 1 центр
  • Riphah international University — Lahore

Публикации

  • Antonarakis SE, Skotko BG, Rafii MS, Strydom A, Pape SE, Bianchi DW, Sherman SL, Reeves RH. Down syndrome. Nat Rev Dis Primers. 2020 Feb 6;6(1):9. doi: 10.1038/s41572-019-0143-7. PMID 32029743

Идентификаторы

NCT: NCT06777394 · REC/RCR & AHS/24/0718

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗