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临床试验/NCT05679817
NCT05679817已完成不适用

Effectiveness of a Dose-graded Aerobic Exercise Regimen on Cardiopulmonary Fitness and Physical Performance in Children Survivors of Acute Lymphoblastic Leukemia: A Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2021年10月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
1
主要终点
Peak oxygen uptake

研究概览

简要总结

The purpose of this study was to evaluate the impact of a 12-week dose-graded aerobic exercise program (D-GAE) on cardiopulmonary fitness and physical performance in children survivors of acute lymphoblastic leukemia (ALL). A total of 58 ALL survivors were randomly assigned to the D-GAE group (n = 29, who underwent a combination of traditional physical rehabilitation and intensity- and duration-graded aerobic training three times per week for 12 weeks) or the control group (n = 29, who underwent only traditional physical rehabilitation).

Cardiopulmonary fitness and physical performance were evaluated in both groups before and after treatment.

详细描述

Fifty-eight survivors of ALL were recruited from the hematology-oncology polyclinic at King Khalid Hospital and two referral pediatric hospitals in Riyadh, Saudi Arabia. The study included survivors aged 10-18 years, who completed maintenance therapy, had no abnormalities of the lower limbs or spine and did not participate in a regular exercise program (in the past six months). survivors who had secondary malignancies, significant musculoskeletal/neurological issues affecting the capacity to participate in exercises or neurocognitive impairments were excluded.

Outcome measures

  1. Cardiopulmonary fitness: The peak oxygen uptake was assessed through the McMaster cycling protocol.
  2. Physical Performance: Three tests were used; the 6-minute walk test, the timed up and down stairs test, and the 4x10 meter Shuttle Run test.

Interventions

The D-GAE group received a 12-week aerobic training, three times in addition to the traditional physical rehabilitation. The D-GAE program commenced with a training intensity corresponding to 50% of the maximum age-predicted heart rate for 25 minutes in the first two weeks, which progressed on a two-week basis, and ended up with a training intensity corresponding to 75% of the maximum age-predicted heart rate for 50 minutes in the last two weeks. The D-GAE program included a warm-up for 5 minutes and a cool-down for 5 minutes. The control group received the traditional physical rehabilitation only, 45 minutes per session, three times a week for 12 consecutive weeks. The program consisted of flexibility exercises, strengthening exercises, balance training, and general conditioning exercises.

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 (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
否

入选标准

  • •Survivors of childhood ALL
  • •Age of 10-18 years
  • •Completion of maintenance therapy
  • •Free of lower limb or spinal deformities
  • •Not participating in regular exercise regimens in the past six months

排除标准

  • •Secondary malignancies
  • •Significant musculoskeletal/neurological issues
  • •Neurocognitive impairments

研究组 & 干预措施

D-GAE group

Experimental

This group received a 12-week aerobic training in addition to the traditional physical rehabilitation.

干预措施: Dose-graded aerobic exercises (Other)

Control group

Active Comparator

This group received the traditional physical rehabilitation only

干预措施: Traditional physical rehabilitation (Other)

结局指标

主要结局

Peak oxygen uptake

时间窗: 3 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

  • 4x10 meter Shuttle Run test(3 months)
  • Six-minute walk test.(3 months)
  • Timed up and down stairs test(3 months)

研究者

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

Ragab Kamal Elnaggar

Associate Professor

Cairo University

研究点 (1)

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