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临床试验/NCT06777394
NCT06777394招募中不适用

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

Riphah International University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Four square balance test

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Single (Participants) Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment.

入排标准

年龄范围
3 Years 至 14 Years(Child)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •Any neurological condition
  • •History of dementia

研究组 & 干预措施

Experimental group

Experimental

task oriented training, group A perform high intensity interval training in addition to routine physical therapy routine exercise giving short burst of intense work for 15 second to 4 mins

干预措施: High intensity interval training (Other)

control group

Other

Routine treatment , streching and normal range of motion exercise should be taught to the patients. low intensity and aerobic exercise perform

干预措施: Routine treatmet (Other)

结局指标

主要结局

Four square balance test

时间窗: 6 weeks

a tool having dynamic balance and coordination. its ability to step over low objects, forward , sideways and backward

次要结局

  • 6 minutes walk test for endurance(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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