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临床试验/NCT07440407
NCT07440407已完成不适用

Aerobic Reconditioning in Post-Cardiac Surgery Patients: A Pragmatic Real-World Application of a Predictive Equation for Exercise Prescription

Istituti Clinici Scientifici Maugeri SpA1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2022年3月30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
118
试验地点
1
主要终点
Functional Capacity (6-Minute Walk Test)

研究概览

简要总结

Brief Summary

After heart surgery, aerobic exercise is essential for recovery. Traditional exercise planning uses a cardiopulmonary exercise test (CPET), which may be unavailable early after surgery. This study tested a six-minute walk test (6MWT)-based method.

Patients aged 30-65 were randomized to either 6MWT-guided or symptom-guided exercise. They completed 14 supervised cycling sessions over two weeks. Safety, exercise progression, training volume, functional capacity, physical performance, and quality of life were measured.

Out of 118 patients, 109 completed the program with no serious exercise-related events. The 6MWT group started at higher intensity and achieved greater training volume. Both groups improved similarly in functional and quality-of-life measures, showing the 6MWT method is safe, feasible, and non-inferior to the traditional approach.

详细描述

Aerobic exercise is essential in early cardiac rehabilitation after cardiac surgery. While cardiopulmonary exercise testing (CPET) is the reference standard, it is often impractical in the early postoperative phase. This single-center randomized controlled trial evaluated a six-minute walk test (6MWT)-derived predictive equation for exercise prescription versus a traditional symptoms-based approach (Borg CR10 scale).

Patients aged 30-65 years, admitted to inpatient rehabilitation one week after cardiac surgery (CABG, valve, or combined), were randomized 1:1 to 14 supervised cycling sessions over two weeks. Outcomes included feasibility, safety, workload progression, functional capacity (6MWT), physical performance (SPPB), and quality of life (EQ-5D).

Of 118 enrolled patients, 109 completed the program. No serious exercise-related adverse events occurred. The 6MWT-based group started at higher workloads and achieved greater cumulative training volume. Both groups improved in functional capacity, physical performance, and quality of life, demonstrating non-inferiority of the 6MWT method.

The 6MWT-derived predictive equation provides a safe, feasible, and effective alternative for aerobic exercise prescription when CPET is unavailable.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (≥18 years- 65 years) admitted to cardiac rehabilitation following cardiac surgery
  • Clinically stable condition at the time of enrollment
  • Ability to understand and sign informed consent
  • ability to perform a six-minute walking test (6MWT) without assistive devices

排除标准

  • Severe cognitive impairment preventing participation
  • Unstable clinical conditions or acute complications
  • Severe comorbidities limiting participation in rehabilitation
  • Refusal or inability to provide informed consent

研究组 & 干预措施

Equation-Based Prescription

Experimental

Participants in this group receive an aerobic exercise program based on a predictive equation derived from the six-minute walk test (6MWT). The maximal workload is estimated from 6MWT performance, and participants complete 14 supervised cycling sessions over two weeks. Exercise intensity is individually tailored and progressively increased according to the predictive equation.

干预措施: Equation-Based Aerobic Exercise Prescription (Other)

Symptoms-Based Prescription

Experimental

Participants in this group receive an aerobic exercise program guided by perceived exertion, using the Borg CR10 scale (target 4-6). They complete 14 supervised cycling sessions over two weeks, with exercise intensity adjusted according to symptom feedback during each session.

干预措施: Symptoms-Based Aerobic Exercise Prescription (Other)

结局指标

主要结局

Functional Capacity (6-Minute Walk Test)

时间窗: Baseline to 2 weeks (end of intervention)

Distance covered during the 6-minute walk test (6MWT) to assess improvements in functional capacity following aerobic exercise prescription after cardiac surgery.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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