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临床试验/NCT06338020
NCT06338020已完成不适用

Effects of Adaptive Variable-resistance Training on Chemotherapy-induced Sarcopenia, Fatigue, and Functional Restriction in Pediatric Survivors of Acute Lymphoblastic Leukemia: A Large-scale Randomized Controlled Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2022年12月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
1
主要终点
Muscle strength

研究概览

简要总结

This study was designed to investigate the effect of eight weeks of adaptive variable-resistance training (Adaptive-VRT) on chemotherapy-induced sarcopenia, fatigue, and functional restrictions in a convenience sample of pediatric survivors of acute lymphoblastic leukemia (ALL). Sixty-two pediatric survivors of ALL were randomly allocated to the experimental group (n = 31, received the adaptive variable-resistance training) or the Control group (n = 31, received standard physical therapy care). Both groups were assessed for muscle mass, strength, fatigue, and functional capacity before and after treatment.

详细描述

Sixty-two pediatric survivors of ALL participated in the study. They were recruited from the Pediatric Oncology/Hematology departments of three referral hospitals in Riyadh region, Saudi Arabia. They were between 12 and 18 years old, completed chemotherapy, had secondary sarcopenia, had normal cardiac structure and function, had no lower limb deformities, and did not engage in regular exercise regimens. They were excluded if they had secondary cancers, neurodegenerative impairments affecting memory, attention, or executive functioning, or neuro-musculoskeletal conditions likely to impede the training like recurrent intensive cramps or impaired proprioceptive functions.

Outcome measures

  1. Muscle thickness: the thigh muscle thickness was assessed using a standard high-resolution ultrasound imaging system.
  2. Muscle strength: The peak concentric torque of the right and left quadriceps was measured through an isokinetic dynamometer.
  3. Fatigue: the general fatigue perception was evaluated using the Pediatric Quality of Life Inventory-Multidimensional Fatigue Scale.
  4. Functional capacity: Three tests were used; the 6-minute walk test, the timed up and down stairs test, and the 4x10 meter Shuttle Run test.

The experimental group received an adaptive-VRT program, three times a week, for six consecutive weeks, in conformity with the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The training protocol included maximum voluntary concentric knee flexor/extensor actions through a motion range between 10 and 90 degrees. Three sets of five to 10 repetitions at angular speeds of 240, 180, and 120 degrees/second were performed. The training started with a warm-up for 10 minutes and ended with a cool-down for 5 minutes.

The control group received the standard exercise program, 45 minutes per session, three times a week, for eight consecutive weeks. The program consisted of flexibility exercise, manual/mechanical strength training, and moderate-intensity aerobic exercises on a treadmill or bicycle ergometer.

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

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

入排标准

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

入选标准

  • Age between 12 and 18 years old
  • Complete maintenance chemotherapy
  • Secondary sarcopenia
  • 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.

结局指标

主要结局

Muscle strength

时间窗: 2 months

Muscle strength was indicated by the peak concentric torque of the knee extensors (Nm). It was measured using an Isokinetic Dynamometer.

Thigh muscle thickness

时间窗: 2 months

The distance between the anterior fascia of the rectus femoris muscle and the posterior fascia of the vastus intermedius muscle. It was measured using a high-resolution ultrasound imaging system.

次要结局

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