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Multimodal Prehabilitation in Thoracic Surgery

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ClinicalTrials.gov Identifier: NCT04052100
Recruitment Status : Recruiting
First Posted : August 9, 2019
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
Anael Barberan-Garcia, Hospital Clinic of Barcelona

Brief Summary:
This trial aims to assess the impact of a multimodal prehabilitation program in high-risk patients undergoing lung resection surgery.

Condition or disease Intervention/treatment Phase
Lung Cancer Other: Usual care Other: Multimodal prehabilitation Not Applicable

Detailed Description:

This trial aims to assess the cost-effectiveness of a multimodal prehabilitation program in high-risk patients undergoing lung resection surgery. Secondary objectives are to evaluate the impact of the intervention on: i) Healthcare resuorces use; ii) clinical outcomes; and, iii) patient's and professionals experience with the program.

The program includes X main interventions: i) A motivational interview; ii) A high-intensity exercise training program; iii) A plan for physical activity incentivation; iv) A nutritional optimization program; v) A psicologichal support program; and, vi) A smoking cessation program.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cost-effectiveness of a Multimodal Prehabilitation Program in High-risk Patients Undergoing to Lung Resection: A Randomized Clinical Trial
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Usual care
Patients following the standard preoperative policies of opur institution
Other: Usual care
The standard preoperative measures will consist of a recommendation for physical activity and advice on tobacco smoking cessation and reduction of alcohol intake. In addition, patients who suffer from iron deficient anemia will receive intravenous iron and those at risk of malnutrition (Malnutrition Universal Screening Tool ≥2 (www.bapen.org.uk/pdfs/must/must_full.pdf)) or that require weight control for obesity (IMC≥30) will perform a nutrition intervention by a nutritionist.

Experimental: Prehabilitation
Patients following the standard preoperative policies of opur institution and the multimodal prehabilitation program
Other: Multimodal prehabilitation

The experimental group will also carry out a prehabilitation program consisting in:

A. A motivational interview to reinforce the patient's motivation and generate a commitment in relation to the objectives of the program.

B. A physical activity promotion program to increase the number of daily steps of patients, measured by a wristband and a mobile App.

C. A supervised high-intensity exercise training program. D. An individualized nutritional optimization plan with dietary advice and protein supplementation (if necessary). Educational material and motivational messages will be sent through a mobile App.

F. Psychological support through weekly Mindfulness sessions (1.5 hours duration). Educational material and motivational messages will be sent through a mobile App.

E. A smoking cessation program consisting psycho-cognitive therapy combined with pharmacological treatment. Educational material and motivational messages will be sent through a mobile App.

Other Name: Prehabilitation




Primary Outcome Measures :
  1. Hospital length of stay [ Time Frame: During initial hospitalization ]
    Hospital days of stay


Secondary Outcome Measures :
  1. Postoperative complications [ Time Frame: During initial hospitalization ]
    Number and severity of postoperative complications

  2. 30-day hospital readmissions [ Time Frame: To 30 days after surgery ]
    Hospital readmissions during the first 30 days after surgery

  3. 30-day emergency room visits [ Time Frame: To 30 days after surgery ]
    Emergency room visits during the first 30 days after surgery

  4. Physical activity [ Time Frame: Baseline and pre-surgery ]
    Physical activity measured by the Yale Physical Activity Survey (YPAS) (range 0-126 points (the higher, the better))

  5. Aerobic capacity [ Time Frame: Baseline and pre-surgery ]
    Exercise endurance time achieved in a constant work-rate exercise test in cycle-ergometer

  6. Self-perceived physical status [ Time Frame: Baseline and pre-surgery ]
    Physical status measured by the physical domain of the SF-36 questionnaire (range 0-100 points (the higher, the better))

  7. Self-perceived mental status [ Time Frame: Baseline and pre-surgery ]
    Mental status measured by the mental domain of the SF-36 questionnaire (range 0-100 points (the higher, the better))

  8. Psychological status [ Time Frame: Baseline and pre-surgery ]
    Anxiety and depression levels measured by the Hospital Anxiety and Depression (HAD) questionnaire (range 0-42 points (the lower, the better))

  9. Fat free mass index [ Time Frame: Baseline and pre-surgery ]
    Fat free mass index measured by bioimpedance

  10. PCR [ Time Frame: Baseline and pre-surgery ]
    Blood levels of PCR

  11. ultrasensible PCR [ Time Frame: Baseline and pre-surgery ]
    Blood levels of ultrasensible PCR

  12. TNF-α [ Time Frame: Baseline and pre-surgery ]
    Blood levels of TNF-α

  13. IL-6 [ Time Frame: Baseline and pre-surgery ]
    Blood levels of IL-6

  14. IL-8 [ Time Frame: Baseline and pre-surgery ]
    Blood levels of IL-8

  15. IL-10 [ Time Frame: Baseline and pre-surgery ]
    Blood levels of IL-10

  16. 8-isoprostane [ Time Frame: Baseline and pre-surgery ]
    Blood levels of 8-isoprostane

  17. fibrinogen [ Time Frame: Baseline and pre-surgery ]
    Blood levels of fibrinogen

  18. leptin [ Time Frame: Baseline and pre-surgery ]
    Blood levels of leptin

  19. adiponectin [ Time Frame: Baseline and pre-surgery ]
    Blood levels of adiponectin

  20. white cells [ Time Frame: Baseline and pre-surgery ]
    Blood levels of white cells



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Forced espiratory volume in the first second (FEV1) and/or estimated postoperative lung diffusion capacity for carbon monoxide < 60%; and/or,
  2. American Society of Anesthesiologist (ASA) index 3-4; and/or,
  3. Peak oxygen uptake among 10-20 mL/kg/min.

Exclusion Criteria:

  1. Non-elective surgery;
  2. Metastasic disease;
  3. Unestable cardiac or respiratory condition; 4) Cognitive or locomotor limitations precluding the adherence to the program.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04052100


Contacts
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Contact: Maria Sanchez +34 932775540 masanchezm@clinic.cat

Locations
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Spain
Hospital Clínic de Barcelona Recruiting
Barcelona, Catalonia, Spain, 08036
Contact: Anael Barberan-Garcia, PhD    +34 932775540    anaelbg@gmail.com   
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
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Principal Investigator: Anael Barberan-Garcia, PhD Hospital Clinic of Barcelona
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anael Barberan-Garcia, Principal investigator, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT04052100    
Other Study ID Numbers: HCB/2018/1138
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anael Barberan-Garcia, Hospital Clinic of Barcelona:
Prehabilitation
Exercise training
Physical activity
Nutrition
Cognitive behavioural therapy
Smoking cessation