Pulmonary Rehabilitation After Minimal Invasive Surgery in Lung Cancer

NCT ID: NCT05136300

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2023-07-01

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.

Conditions

Lung Cancer; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Pulmonary rehabilitation

Intervention Type: BEHAVIORAL

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.

Control

Standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Pain clinic

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Isala

OTHER

Sponsor Role: lead

Responsible Party

Lars Dinjens

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

J Stigt

Role: PRINCIPAL_INVESTIGATOR

Isala

Locations

Isala

Zwolle, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Lars Dinjens

Role: CONTACT

ldinjens@isala.nl

0384244597

Facility Contacts

L Dinjens, MD

Role: primary

Other Identifiers

ABR 63724

Identifier Type: -

Identifier Source: org_study_id