Pulmonary Rehabilitation After Minimal Invasive Surgery in Lung Cancer

Lung Cancer Clinical Trial

— PROMISE  

Official title:

Pulmonary Rehabilitation After Minimal Invasive Surgery in Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05136300
• Other study ID #: ABR 63724
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: July 1, 2023

Study information

• Verified date: August 2022
• Source: Isala
• Contact: Lars Dinjens
• Phone: 0384244597
• Email: ldinjens[@]isala.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Surgery

Intervention

Behavioral:
• Pulmonary rehabilitation
Patients in the intervention group will receive physical therapy, scheduled pain monitoring and coaching by a social worker. The intensity of the rehabilitation training program will be determined separately for each patient by a steepramp and 1-repetition test within 3 weeks post-operative. The intervention group will be trained and educated in 2 sessions of 2 hours per week, for a period of 3 months.

Locations

Country	Name	City	State
Netherlands	Isala	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
Isala

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life (SF-36)	effects of an integrated multidisciplinary rehabilitation program on general quality of life	12 months
Secondary	SGRQ	health-related quality of life	12 months
Secondary	VAS	post-operative pain	12 months
Secondary	WHO-PS	performance score	12 months
Secondary	6 minute walking distance	exercise tolerance	12 months
Secondary	international physical activity questionnaire, iPAQ	physical activity	12 months