Impact of a Telerehabilitation-based Therapeutic Exercise Program on Postoperative Recovery in Patients With Lung Cancer: A Randomized Controlled Trial.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Seville

About this trial

Lung cancer is one of the leading causes of cancer-related morbidity and mortality worldwide. Thoracic surgery remains the treatment of choice for patients with early-stage disease; however, postoperative recovery is frequently associated with reduced functional capacity, decreased physical activity levels, pulmonary complications, dyspnea, and impaired quality of life. Early physiotherapy interventions are recommended to minimize these adverse outcomes, although access to postoperative rehabilitation services remains limited in many healthcare settings, including the Andalusian Public Health System.

Telerehabilitation has emerged as a promising strategy to improve access to rehabilitation services by delivering therapeutic exercise and clinical follow-up remotely. Previous studies have demonstrated that telerehabilitation is safe, effective, and cost-efficient across different clinical populations. However, evidence regarding its effectiveness in patients recovering from lung cancer surgery remains limited.

This single-blind randomized controlled trial aims to compare the effects of an eight-week telerehabilitation program based on therapeutic exercise with usual postoperative care in patients with lung cancer undergoing thoracic surgery. Participants allocated to the intervention group will receive 24 therapeutic exercise sessions and 8 online clinical follow-up sessions delivered through the Rehbody platform over an 8-week period. Outcomes will include functional capacity, dyspnea, physical activity level, postoperative pulmonary complications, and health-related quality of life.

The study is designed to address the following research question: In adults with lung cancer undergoing thoracic surgery (Population), does an eight-week therapeutic exercise-based telerehabilitation program (Intervention), compared with usual postoperative care (Comparison), improve postoperative recovery as measured by functional capacity, dyspnea, physical activity level, postoperative pulmonary complications, and quality of life (Outcomes)?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 to 80 years.

Histologically confirmed primary lung cancer (stage 0 to IIIB).

Patients who have undergone thoracic surgery for lung cancer.

Medical clearance to participate in an exercise-based rehabilitation program.

Disqualifiers

Any medical condition or comorbidity that contraindicates participation in an exercise program.

Current psychiatric disorder that may interfere with study participation.

Inability to provide written informed consent.

Previous thoracic surgery.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Therapeutic Exercise-Based Telerehabilitation

    Behavioral

    Participants will receive an 8-week telerehabilitation program delivered through the RehBody platform. The intervention includes 24 supervised therapeutic exercise sessions and 8 online clinical follow-up sessions. Exercise sessions incorporate aerobic training, strength exercises, respiratory muscle training, individualized progression, symptom monitoring, and adherence support. Participants will also receive usual postoperative care.

  • Usual Postoperative Care

    Other intervention

    Participants assigned to the control group will receive usual postoperative care routinely provided after thoracic surgery for lung cancer. This includes early mobilization, progressive ambulation according to individual tolerance, deep breathing exercises, active upper-limb and trunk mobility exercises, cough training with wound protection, and discharge recommendations for home-based recovery. No structured telerehabilitation or supervised exercise program will be provided after hospital discharge.

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Telerehabilitation + Usual CareActive comparator 1 intervention
Group B: Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Functional Capacity

Functional capacity will be assessed using the One-Minute Sit-to-Stand Test (1MSTS). Participants will be instructed to stand up and sit down from a standardized chair as many times as possible within one minute. The total number of completed repetitions will be recorded, with higher scores indicating better functional capacity.

Time frame
Baseline (pre-surgery), 8 weeks (post-intervention), and 12 weeks (4-week follow-up)

Secondary outcomes

1

Dyspnea

Dyspnea will be assessed using the Modified Medical Research Council (mMRC) scale. This is a 5-point ordinal scale (0-4) where higher scores indicate greater breathlessness and functional limitation due to dyspnea.

Time frame
Baseline, 8 weeks, and 12 weeks
2

Physical Activity Level

Physical activity will be assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). Results will be expressed in MET-minutes/week and categorized into low, moderate, or high physical activity levels according to standardized scoring protocols.

Time frame
Baseline, 8 weeks, and 12 weeks
3

Postoperative Pulmonary Complications

Postoperative pulmonary complications will be collected from clinical records and defined according to EPCO (European Perioperative Clinical Outcome) criteria. Complications will be recorded from hospital discharge until the end of the intervention and follow-up period.

Time frame
Post-surgery to 12-week follow-up
4

Health-Related Quality of Life

Health-related quality of life will be assessed using the EQ-5D-5L questionnaire, including the descriptive system (five dimensions with five levels each) and the EQ visual analogue scale (EQ-VAS, 0-100). Higher scores indicate better perceived health status.

Time frame
Baseline, 8 weeks, and 12 weeks

Other outcomes

Sponsors and contacts

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University of Seville

Lead sponsor

Hospital Universitario Virgen Macarena

Collaborator

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