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临床试验/NCT05473052
NCT05473052已完成不适用

Home-based Preoperative Exercise Training for Lung Cancer Patients Undergoing Surgery: A Feasibility Trial

Instituto Politécnico de Leiria2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年2月1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
15
试验地点
2
主要终点
Retention rate

研究概览

简要总结

Surgical resection is the only curative treatment in patients diagnosed with lung cancer, the most mortal type of malignancy globally. However, following lung cancer resection, patients experience a substantial deterioration in health-related quality of life and have an increased risk of developing pulmonary complications.

Although current clinical guidelines strongly recommend preoperative exercise training to improve clinical outcomes after lung cancer surgery, inaccessibility to facility-based exercise programs is a major barrier to routine participation, with patients indicating a strong preference to exercise in a home-based environment.

The primary purpose of the present study was to evaluate the feasibility of a home-based exercise program (HBEP) in lung cancer patients awaiting surgical treatment. The secondary purposes were to evaluate the safety of the HBEP and to explore exercise effects on patients' HRQOL and physical performance, either pre-and post-surgery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Scheduled for surgical treatment of suspected or confirmed lung cancer (clinical stage IIIA or less)
  • Waiting time for surgery of at least two weeks from baseline assessment
  • Medical clearance to exercise.
  • Signed informed consent prior to initiation of study-related procedures.

排除标准

  • Metastatic cancer
  • Presence of physical or mental disabilities that contraindicated exercise training or physical testing
  • Unable to communicate in Portuguese or English
  • Performing combined aerobic plus resistance training over the past month (self-reported ≥2 days a week, ≥30 minutes each session).

结局指标

主要结局

Retention rate

时间窗: Baseline to 4-5 weeks after surgery

Defined as the ratio of patients who completed the study to those who were recruited, expressed as a percentage

Exercise attendance rate

时间窗: Baseline to 2-3 days before surgery

Attendance rate will be defined as the ratio of total completed to planned exercise sessions, expressed as a percentage.

Recruitment rate

时间窗: Baseline

Defined as the ratio of recruited patients to those who were eligible, expressed as a percentage.

Exercise compliance rate

时间窗: Baseline to 2-3 days before surgery

Compliance rate will be defined as the ratio of total completed to planned training volume, expressed as a percentage.

次要结局

  • Adverse events(Baseline to 2-3 days before surgery)
  • Changes in health-related quality of life(Baseline to 4-5 weeks after surgery)
  • Changes in exercise capacity(Baseline to 4-5 weeks after surgery.)
  • Changes in handgrip strength(Baseline to 4-5 weeks after surgery)
  • Changes in five times sit to stand test(Baseline to 4-5 weeks after surgery)

研究者

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

Pedro Machado

Principal Investigator

Instituto Politécnico de Leiria

研究点 (2)

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