Pulmonary Rehabilitation After Minimal Invasive Surgery in Lung Cancer

NCT05136300 | Unknown DMC

• 1 other identifier: ABR 63724
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Quality of life (SF-36)

  effects of an integrated multidisciplinary rehabilitation program on general quality of life

  12 months

Secondary Outcomes (5)

• SGRQ

  12 months

• VAS

  12 months

• WHO-PS

  12 months

• 6 minute walking distance

  12 months

• international physical activity questionnaire, iPAQ

  12 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Pulmonary rehabilitation

Control

NO INTERVENTION

Standard of care

Interventions

Pulmonary rehabilitation 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.

Also known as: Pain clinic

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with chronic pain
• Previous pulmonary surgery
• Comorbidity limiting rehabilitation
• Rheumatoid arthritis
• Severe ischaemic heart disease or myocardial failure; EF ≤ 35 %.
• Muscle disease
• Fibromyalgia
• Neurologic disorders (Parkinson disease, CVA and lesions of the spinal cord)
• Psychiatric disorders

Sponsors & Collaborators

• Isala: lead

Study Sites (1)

Isala

Zwolle, Netherlands

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Pain Clinics

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Outpatient Clinics, Hospital; Ambulatory Care Facilities; Health Facilities; Health Care Facilities Workforce and Services; Hospital Departments; Hospital Administration; Health Facility Administration; Organization and Administration; Health Services Administration

Study Officials

• J Stigt

  Isala

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Dinjens

CONTACT

0384244597; ldinjens@isala.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: RCT

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: November 29, 2021
• Study Start: May 1, 2019
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)