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临床试验/NCT06326632
NCT06326632已完成不适用

Constant-load Versus Graded Aerobic Exercise for Promoting Cardiorespiratory Fitness and Functional Capacity in Obese Children With Bronchial Asthma: a Randomized Comparative Effectiveness Inquiry

Cairo University1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2022年10月30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
78
试验地点
1
主要终点
Peak oxygen uptake

研究概览

简要总结

This study aimed to compare the effect of constant-load aerobic exercise (CL-AE) and graded aerobic exercise (G-AE) on cardiopulmonary fitness, and functional capacity in a cohort of obese children with bronchial asthma (BA).

A total of 78 children with BA were randomly assigned to the CL-AE group (n = 26, who underwent moderate-intensity aerobic training with the training load maintained at the same level throughout the entire program, besides the respiratory re-training program), the G-AE group (n = 26, received an intensity- and duration-graded aerobic training in addition to the respiratory re-training program), or the control group (n = 29, who only engaged in a respiratory re-training program). Interventions were administered three times/week for 12 successive weeks.

The cardiopulmonary fitness and functional capacity were evaluated in the three groups before and after the completion of the assigned interventions.

详细描述

Seventy-eight children with BA were recruited from the Pulmonary Medicine/Critical Care and Allergy-Immunology at King Khalid Hospital and two referral hospitals in Riyadh, Saudi Arabia. The study included children with moderate, clinically stable BA, aged 8-18 years, had a body mass index between 30 to 35 kg/m2, had no abnormalities of the lower limbs or spine, maintained constant medication dosages in the past three months, and did not engage in a regular exercise program (in the past six months). Children were excluded if they had exacerbated asthma symptoms, chronic lung comorbidities, and cardiovascular or musculoskeletal conditions expected to hinder the training.

Outcome measures

Cardiopulmonary fitness: The peak oxygen uptake was assessed through the McMaster cycling protocol.

Functional Capacity: The 6-minute walk test was used to assess the submaximal functional capacity Perceived dyspnea and fatigue: Borg's category ratio scale (CR-10) was used to explore how much dyspnea and fatigue they perceived after the 6-minute walk 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
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
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age of 8-18 years
  • Body mass index ranging from 30 to 35 kg/m2
  • Verified asthma diagnosis per the Global Initiative for Asthma (GINA) criteria
  • Moderate Onset
  • Clinically Stable
  • Maintained medication dosages in the past three months
  • Free of lower limb or spinal deformities
  • Not engaging in regular exercise regimens in the past six months.

排除标准

  • Exacerbated asthma symptoms
  • Chronic lung comorbidities
  • Cardiovascular or musculoskeletal conditions expected to hinder the training.

研究组 & 干预措施

CL-AE group

Experimental

The CL-AE group received a 12-week constant-load aerobic training besides the respiratory retraining program.

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

G-AE group

Experimental

The G-AE group received a 12-week intensity- and duration-graded aerobic training in addition to the respiratory re-training.

干预措施: Graded Aerobic exercise (Other)

Control group

Active Comparator

The control group received the respiratory re-training only for 12 consecutive weeks.

干预措施: Respiratory Re-training (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

  • Dyspnea(3 months)
  • Six-minute walk test(3 months)
  • Fatigue(3 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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