Postoperative Rehabilitation in Operation for LUng CAncer (PROLUCA)

NCT02439073 | Unknown DMC

• 1 other identifier: H-3-2012-028
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose The purpose of the PROLUCA study is to investigate the efficacy of early postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer, with focus on exercise training. Design/Methods One hundred and twenty-eight (n=128) participants (64 patients/study arm) with Non-Small Cell Lung Cancer (NSCLC), stage I-IIIa, referred for surgery, will be randomized to one of the following two groups:

1. 1.Early postoperative rehabilitation initiated as early as two weeks after surgery
2. 2.Postoperative rehabilitation initiated 14 weeks after surgery Intervention The intervention consists of a supervised group exercise program comprising resistance and cardiorespiratory exercise two hours weekly for 12 weeks combined with individual counseling.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• A change in maximum oxygen consumption

  A change in maximum oxygen consumption from baseline to post interventon, measured by a VO2peak, evaluated by an incremental test using an electromagnetically braked cycle ergometer

  A change in maximum oxygen consumption from baseline to post intervention (for group one, the experimental group, it is approximately 14 weeks after the operation and for group two it is approximately 26 weeks after the operation)

Secondary Outcomes (5)

• Patient Reported outcomes

  Baseline, post intervention, follow-up at 26 and 52 weeks after surgery

• Six minutes walk distance

  Baseline, two and 8 weeks after surgery. post intervention, follow-up at 26 and 52 weeks after surgery

• Lung capacity

  Baseline, two and 8 weeks after surgery. post intervention, follow-up at 26 and 52 weeks after surgery

• Muscle strength chest and leg press

  Baseline, post intervention, follow-up at 26 and 52 weeks after surgery

• A change in maximum oxygen consumption

  A change in maximum oxygen consumption from baseline to 52 weeks after operation

Study Arms (2)

early initiated rehabilitation

EXPERIMENTAL

A supervised 12-week rehabilitation program, initiated two weeks post surgery, containing 24 group-based exercise sessions, three individual counseling sessions, and three group-based lessons in health-promoting behavior. If the participants have special needs in terms of smoking cessation, nutritional counseling or patient education, this is offered too.

Behavioral: Rehabilitation

late initiated rehabilitation

ACTIVE COMPARATOR

A supervised 12-week rehabilitation program, initiated 14 weeks post surgery, containing 24 group-based exercise sessions, three individual counseling sessions, and three group-based lessons in health-promoting behavior. If the participants have special needs in terms of smoking cessation, nutritional counseling or patient education, this is offered too.

Behavioral: Rehabilitation

Interventions

Rehabilitation BEHAVIORAL

The postoperative intervention are the same in both intervention groups and consists of a supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions, and three group-based lessons in health-promoting behavior. If the participants have special needs in terms of smoking cessation, nutritional counseling or patient education, this is offered too.The postoperative physical exercise consists of an individually prepared supervised strength exercise - and a group-based cardiovascular exercise twice a week (60 minutes/session) on non-consecutive days for 12 weeks, a total of 24 sessions.

Also known as: exercise intervention

early initiated rehabilitation; late initiated rehabilitation

Eligibility Criteria

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

You may qualify if:

• All subjects are assigned for curative lung cancer surgery at Department of Cardiothoracic Surgery RT at Copenhagen University Hospital (Rigshospitalet)
• Performance status 0-2 (WHO)
• Living in the City of Copenhagen or surrounding Municipalities
• Ability to read and understand Danish
• Approval by primary surgeon

You may not qualify if:

• Presence of metastatic disease or surgical inoperability. Diagnosis of Lung Cancer not verified by histological diagnosis.
• Decompensated heart failure, severe aortic stenosis, uncontrolled arrhythmia, acute coronary syndrome
• Contraindications to maximal exercise testing as recommended by the American Thoracic Society and exercise testing guidelines for cancer patients

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Copenhagen Centre for Cancer and Health

Copenhagen, Capital Region of Denmark, DK-2200, Denmark

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jesper H. Pedersen, MD, MrDSci

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MrDSci

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: May 8, 2015
• Study Start: April 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 24, 2016

Record last verified: 2016-06

Locations

DK (1)