Pulmonary Rehabilitation After Minimal Invasive Surgery in Lung Cancer (PROMISE)

Isala

Status: Enrolling

Conditions: Surgery; Lung Cancer

Treatments: Behavioral: Pulmonary rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05136300

ABR 63724

Details and patient eligibility

About

Morbidity in the post-operative phase of pulmonary surgery is characterised by impairment due to pain, dyspnoea and loss of exercise tolerance. We demonstrated previously that rehabilitation after thoracotomy is limited due to pain. Since minimal invasive surgery is the new standard in lung cancer, resulting in a reduction of postoperative pain, we believe there are new possibilities for post-operative integrated multidisciplinary rehabilitation in lung cancer.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients undergoing elective, minimal invasive surgery with intention to cure.
2. Age between 18 and 80 years.
3. ECOG 0 - 2 post-surgery.

Exclusion criteria

1. Patients with chronic pain

2. Previous pulmonary surgery

3. Comorbidity limiting rehabilitation

   1. Rheumatoid arthritis
   2. Severe ischaemic heart disease or myocardial failure; EF ≤ 35 %.
   3. Muscle disease
   4. Fibromyalgia
   5. Neurologic disorders (Parkinson disease, CVA and lesions of the spinal cord)
   6. Psychiatric disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Intervention

Experimental group

Description:

An integrated multidisciplinary rehabilitation program on general quality of life (short form 36, SF-36, subdomain general health) in the 12 months postoperative period in patients undergoing elective minimal invasive surgery in lung cancer

Treatment:

Behavioral: Pulmonary rehabilitation

Control

No Intervention group

Description:

Standard of care