Multimodal Prehabilitation in Thoracic Surgery
Cost-effectiveness of a Multimodal Prehabilitation Program in High-risk Patients Undergoing to Lung Resection: A Randomized Clinical Trial
1 other identifier
interventional
158
1 country
1
Brief Summary
This trial aims to assess the impact of a multimodal prehabilitation program in high-risk patients undergoing lung resection surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable lung-cancer
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2019
CompletedFirst Posted
Study publicly available on registry
August 9, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedDecember 11, 2019
December 1, 2019
1.7 years
April 5, 2019
December 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospital length of stay
Hospital days of stay
During initial hospitalization
Secondary Outcomes (20)
Postoperative complications
During initial hospitalization
30-day hospital readmissions
To 30 days after surgery
30-day emergency room visits
To 30 days after surgery
Physical activity
Baseline and pre-surgery
Aerobic capacity
Baseline and pre-surgery
- +15 more secondary outcomes
Study Arms (2)
Usual care
ACTIVE COMPARATORPatients following the standard preoperative policies of opur institution
Prehabilitation
EXPERIMENTALPatients following the standard preoperative policies of opur institution and the multimodal prehabilitation program
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Forced espiratory volume in the first second (FEV1) and/or estimated postoperative lung diffusion capacity for carbon monoxide \< 60%; and/or,
- American Society of Anesthesiologist (ASA) index 3-4; and/or,
- Peak oxygen uptake among 10-20 mL/kg/min.
You may not qualify if:
- Non-elective surgery;
- Metastasic disease;
- Unestable cardiac or respiratory condition; 4) Cognitive or locomotor limitations precluding the adherence to the program.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clínic de Barcelona
Barcelona, Catalonia, 08036, Spain
Related Publications (1)
Barberan-Garcia A, Navarro-Ripoll R, Sanchez-Lorente D, Moises-Lafuente J, Boada M, Messaggi-Sartor M, Gonzalez-Vallespi L, Montane-Muntane M, Alsina-Restoy X, Campero B, Lopez-Baamonde M, Romano-Andrioni B, Guzman R, Lopez A, Arguis MJ, Roca J, Martinez-Palli G. Cost-effectiveness of a technology-supported multimodal prehabilitation program in moderate-to-high risk patients undergoing lung cancer resection: randomized controlled trial protocol. BMC Health Serv Res. 2020 Mar 12;20(1):207. doi: 10.1186/s12913-020-05078-9.
PMID: 32164687DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anael Barberan-Garcia, PhD
Hospital Clinic of Barcelona
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
April 5, 2019
First Posted
August 9, 2019
Study Start
October 1, 2019
Primary Completion
May 31, 2021
Study Completion
June 30, 2021
Last Updated
December 11, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share