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

August 2, 2022 updated by: Lars Dinjens, Isala
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Zwolle, Netherlands
        • Recruiting
        • Isala
        • Contact:
          • L Dinjens, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Standard of care
Experimental: 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
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.

Other Names:
  • Pain clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (SF-36)
Time Frame: 12 months
effects of an integrated multidisciplinary rehabilitation program on general quality of life
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isala

Investigators

  • Principal Investigator: J Stigt, Isala

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

November 17, 2021

First Submitted That Met QC Criteria

November 17, 2021

First Posted (Actual)

November 29, 2021

Study Record Updates

Last Update Posted (Actual)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABR 63724

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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