PulmoSalud: Multimodal Program for Prehabilitation and Early Home Rehabilitation in Patients With Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 主要终点
- FEV1/FVC:
研究概览
简要总结
Lung cancer remains a leading cause of morbidity and mortality, and resective surgery is the treatment of choice in operable stages. However, a significant proportion of patients present with functional impairment prior to surgery and develop postoperative complications, especially respiratory ones. Prehabilitation has become established as a strategy capable of optimizing physical condition before surgery, while early rehabilitation contributes to accelerating recovery after discharge. Nevertheless, its routine implementation is limited by logistical barriers, short waiting times, and difficulties in accessing in-person care.
The PulmoSalud project proposes a multimodal program, consisting of 8 weeks of prehabilitation (strength and endurance exercises, and respiratory physiotherapy) and 4 weeks of early home-based rehabilitation, supported by a specific digital application, in order to facilitate continuity of care without the need for additional travel. The content includes progressive strength training, structured breathing exercises (including inspiratory muscle training), educational guidelines, and digital recording of activity and symptoms. Patients will receive initial in-person training to ensure the correct execution of the exercises, and will subsequently continue independently with remote supervision.
A controlled study will be conducted comparing this program with the center's standard care. Functional variables (aerobic capacity, muscle strength), respiratory parameters, postoperative complications, quality of life, self-efficacy, and healthcare resource utilization will be evaluated. Measurements will be taken at three time points: baseline (T0), immediate pre-surgical (T1), and one month post-surgery (T2).
PulmoSalud aims to improve preoperative preparation, accelerate post-surgical recovery, and reduce the burden on healthcare services by safely integrating a home-based intervention supported by digital technology.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Histological or cytological diagnosis of lung cancer (resectable stage according to the multidisciplinary team).
- •Patients scheduled for lung surgery with curative intent (lobectomy, segmentectomy, pneumonectomy, etc.).
- •Ability to understand and sign informed consent.
- •Clinical condition that allows participation in a supervised exercise program, according to medical evaluation, with an ECOG performance status of 0-2 (Eastern Cooperative Oncology Group Performance Status).
- •Availability to perform the scheduled measurements and follow-ups (preoperative and postoperative).
- •Ability to use the mobile application or have family support to do so.
排除标准
- •1. Absolute medical contraindications to supervised physical exercise, such as unstable angina, recent decompensated heart failure, uncontrolled arrhythmias, or acute cardiovascular events within the last 3 months.
- •2. Very advanced chronic lung disease that prevents participation in the program (e.g., severe COPD with FEV1 < 30% predicted, as determined by the clinical team).
- •3. Distant metastases or metastatic cancer that contraindicate surgery with curative intent.
- •4. Planned palliative surgery or life expectancy < 3 months.
- •5. Home oxygen therapy with severe, uncorrectable hypoxemia, as determined by clinical judgment.
- •6. Moderate-to-severe cognitive, neurological, or psychiatric impairment that prevents understanding of the study or proper use of the mobile application.
- •An insurmountable language barrier that prevents understanding the study information or using the mobile application.
- •8. Pregnancy.
- •9. Participation in another interventional clinical trial that may interfere with the study objectives or its primary outcome.
- •10. Any other condition that, in the opinion of the research team, compromises the participant's safety or adherence to the protocol.
- •Withdrawal Criteria
- •Withdrawal of consent.
- •Adverse events that contraindicate continued exercise (clinical decision).
- •Failure to complete more than 30% of planned sessions (for per-protocol analysis; continue in ITT).
研究组 & 干预措施
intervention group
Prehabilitation and postoperative rehabilitation. The prehabilitation phase, lasting 8 weeks, includes a supervised, in-person program of progressive, individualized physical exercise (strength, endurance, and neuromuscular training), along with specific respiratory training designed to prepare the patient for the postoperative period. During this stage, physiotherapists teach and practice with the patient all the breathing, ventilation, and secretion management techniques that they will later perform independently. After surgery, the rehabilitation phase begins, lasting 4 weeks and conducted entirely at home to facilitate early intervention and avoid travel. In this stage, the patient applies the previously learned breathing exercises, adapted to their clinical progress, while receiving remote monitoring and adjustments from the research team.
干预措施: Individualized pre-operative physical exercise (Other)
intervention group
Prehabilitation and postoperative rehabilitation. The prehabilitation phase, lasting 8 weeks, includes a supervised, in-person program of progressive, individualized physical exercise (strength, endurance, and neuromuscular training), along with specific respiratory training designed to prepare the patient for the postoperative period. During this stage, physiotherapists teach and practice with the patient all the breathing, ventilation, and secretion management techniques that they will later perform independently. After surgery, the rehabilitation phase begins, lasting 4 weeks and conducted entirely at home to facilitate early intervention and avoid travel. In this stage, the patient applies the previously learned breathing exercises, adapted to their clinical progress, while receiving remote monitoring and adjustments from the research team.
干预措施: Post-operative rehabilitation physical exercise (Other)
intervention group
Prehabilitation and postoperative rehabilitation. The prehabilitation phase, lasting 8 weeks, includes a supervised, in-person program of progressive, individualized physical exercise (strength, endurance, and neuromuscular training), along with specific respiratory training designed to prepare the patient for the postoperative period. During this stage, physiotherapists teach and practice with the patient all the breathing, ventilation, and secretion management techniques that they will later perform independently. After surgery, the rehabilitation phase begins, lasting 4 weeks and conducted entirely at home to facilitate early intervention and avoid travel. In this stage, the patient applies the previously learned breathing exercises, adapted to their clinical progress, while receiving remote monitoring and adjustments from the research team.
干预措施: Respiratory physiotherapy Prehabilitation (Other)
intervention group
Prehabilitation and postoperative rehabilitation. The prehabilitation phase, lasting 8 weeks, includes a supervised, in-person program of progressive, individualized physical exercise (strength, endurance, and neuromuscular training), along with specific respiratory training designed to prepare the patient for the postoperative period. During this stage, physiotherapists teach and practice with the patient all the breathing, ventilation, and secretion management techniques that they will later perform independently. After surgery, the rehabilitation phase begins, lasting 4 weeks and conducted entirely at home to facilitate early intervention and avoid travel. In this stage, the patient applies the previously learned breathing exercises, adapted to their clinical progress, while receiving remote monitoring and adjustments from the research team.
干预措施: Supporting mobile application (App) (Device)
intervention group
Prehabilitation and postoperative rehabilitation. The prehabilitation phase, lasting 8 weeks, includes a supervised, in-person program of progressive, individualized physical exercise (strength, endurance, and neuromuscular training), along with specific respiratory training designed to prepare the patient for the postoperative period. During this stage, physiotherapists teach and practice with the patient all the breathing, ventilation, and secretion management techniques that they will later perform independently. After surgery, the rehabilitation phase begins, lasting 4 weeks and conducted entirely at home to facilitate early intervention and avoid travel. In this stage, the patient applies the previously learned breathing exercises, adapted to their clinical progress, while receiving remote monitoring and adjustments from the research team.
干预措施: Home-based respiratory physiotherapy (Other)
Control Group
Standard Care
PREHABILITATION:
Participants will receive standard care provided by the center, including the usual clinical recommendations of the thoracic surgery and oncology team. They will remain on the waiting list for lung cancer surgery according to the standard care pathway, without a structured exercise program, scheduled respiratory physiotherapy, or use of the mobile application.
EARLY REHABILITATION Following surgery, participants assigned to the control group will receive standard care provided by the thoracic surgery service, following the center's standard clinical protocols. They will not participate in a structured respiratory physiotherapy program or a supervised exercise plan, and will not have telehealth support or follow-up via a mobile application. Their recovery will proceed according to the standard recommendations of the care team, including pain management.
结局指标
主要结局
FEV1/FVC:
时间窗: From the start of treatment until its completion at 12 weeks.
6 minute walk test (6MWT): continuous quantitative variable (meters).
时间窗: From the start of treatment until its completion at 12 weeks
30-Second Sit-to-Stand Test
时间窗: From the start of treatment until its completion at 12 weeks
FEV1 (L and % predicted)
时间窗: From the start of treatment until its completion at 12 weeks.
FVC (L and % predicted)
时间窗: From the start of treatment until its completion at 12 weeks.
次要结局
- International Physical Activity Questionnaire (IPAQ)(From the start of treatment until its completion at 12 weeks)
- Godin questionnaire(From the start of treatment until its completion at 12 weeks)
- Subjective perception of effort (RPE, scale 0-10)(From the start of treatment until its completion at 12 weeks)
- Submaximal heart rate reached (80%, heart rate monitor)(From the start of treatment until its completion at 12 weeks)
- FAACT-A/CS Questionnaire (anorexia-cachexia)(From the start of treatment until its completion at 12 weeks)
- diet quality(From the start of treatment until its completion at 12 weeks)
- maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)(From the start of treatment until its completion at 12 weeks.)
- Peak Cough Flow (PCF)(From the start of treatment until its completion at 12 weeks.)
- mMRC scale(From the start of treatment until its completion at 12 weeks.)
- modified Borg scale(From the start of treatment until its completion at 12 weeks.)
- Hand grip dynamometry(From the start of treatment until its completion at 12 weeks.)
- Estimated maximum strength 1RM(From the start of treatment until its completion at 12 weeks)
- Bruce's ramp test(From the start of treatment until its completion at 12 weeks)
研究者
FranciscoVeraSerrano
Graduate in Physiotherapy
University of Cadiz