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
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
- Cardiopulmonary fitness: The peak oxygen uptake was assessed through the McMaster cycling protocol.
- 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
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
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
Ragab Kamal Elnaggar
Associate Professor
Cairo University
