Pulmonary Rehabilitation After Minimal Invasive Surgery in Lung Cancer

Not Applicable

• Conditions: Lung Cancer; Surgery
• Interventions: Behavioral: Pulmonary rehabilitation

• Registration Number: NCT05136300
• Lead Sponsor: Isala

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2021-11-17
• Study First Submitted QC: 2021-11-17
• Study First Posted: 2021-11-29
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Pulmonary rehabilitation	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

Primary Outcome Measures

Name	Time	Method
Quality of life (SF-36)	12 months	effects of an integrated multidisciplinary rehabilitation program on general quality of life

Secondary Outcome Measures

Name	Time	Method
VAS	12 months	post-operative pain
international physical activity questionnaire, iPAQ	12 months	physical activity
SGRQ	12 months	health-related quality of life
WHO-PS	12 months	performance score
6 minute walking distance	12 months	exercise tolerance

Trial Locations

Locations (1)

Isala; 🇳🇱 Zwolle, Netherlands