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临床试验/NCT07330141
NCT07330141已完成不适用

Optimizing Post-Chemotherapy Recovery: A Head-to-Head Trial of Graded vs. Constant-Load Aerobic Exercise in Pediatric ALL Survivors

Cairo University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年12月3日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
Peak oxygen uptake

研究概览

简要总结

This study compared the effects of constant-load aerobic exercise (CL-AEx) and graded aerobic exercise (G-AEx) on cardiopulmonary fitness and functional capacity in pediatric survivors of acute lymphoblastic leukemia (ALL).

A cohort of 72 pediatric ALL survivors was randomly assigned to one of three groups: a CL-AEx group (n=24), a G-AEx group (n=24), or a control group (n=24). All groups participated in a structured exercise regimen. The CL-AEx group performed additional moderate-intensity aerobic training at a fixed load, while the G-AEx group performed additional aerobic training with progressive increases in intensity and duration. The control group performed the structured exercise regimen only. Interventions were administered three times per week for 12 consecutive weeks.

Cardiopulmonary fitness and functional capacity were assessed in all three groups at baseline and following the completion of the 12-week intervention.

详细描述

Seventy-two pediatric ALL survivors were recruited from the Pediatric Oncology and Hematology departments of three referral hospitals in the Riyadh region, Saudi Arabia. Inclusion criteria required participants to be aged 10-18 years, have completed chemotherapy, present with secondary sarcopenia, and possess normal cardiac structure and function without lower limb deformities. Participants were also required to be non-regular exercisers. Exclusion criteria included a history of secondary cancers, neurodegenerative impairments affecting memory, attention, or executive function, or any neuromusculoskeletal condition likely to impede training compliance (e.g., recurrent intensive cramps or impaired proprioceptive function).

Outcome Measures

Cardiopulmonary Fitness: Peak oxygen uptake (VO₂ peak) was assessed using the McMaster cycle ergometer protocol.

Functional Capacity: This was evaluated via three performance-based tests: the 6-Minute Walk Test (6MWT), the Timed Up and Down Stairs Test (TUDS), and the 4x10 Meter Shuttle Run Test.

Interventions

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
Double (Care Provider, Outcomes Assessor)

盲法说明

A single-blind protocol was adopted. The researcher who collected the data was blind to the allocation of treatment

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 10 and 18 years old
  • Complete maintenance chemotherapy
  • Normal cardiac structure and function
  • Absence of lower limb deformities
  • Not engaging in regular exercise regimens

排除标准

  • Secondary cancers
  • Neurodegenerative impairments affecting memory, attention, or executive functioning
  • Neuro-musculoskeletal conditions are likely to impede the training.

研究组 & 干预措施

Control group

Active Comparator

The control group received the structured exercise program only for 12 consecutive weeks.

干预措施: Structured Exercise regemin (Other)

CL-AEx group

Experimental

The CL-AEx group received a 12-week constant-load aerobic training besides a structured exercise program.

干预措施: Constant-load Aerobic Exercise (Other)

G-AEx group

Experimental

The G-AEx group received a 12-week intensity- and duration-graded aerobic training in addition to a structured exercise program.

干预措施: Graded Aerobic exercise (Other)

结局指标

主要结局

Peak oxygen uptake

时间窗: 2 months

The peak oxygen uptake (mL/kg/min) was assessed through a symptom-free exercise tolerance test (i.e., the McMaster cycling protocol).

次要结局

  • Six-minute walk test(2 months)
  • 4x10 meter Shuttle Run test(2 months)
  • Timed up and down stairs test(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ragab Kamal Elnaggar

Professor

Cairo University

研究点 (1)

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