Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
158 participants
INTERVENTIONAL
2019-10-01
2021-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Usual care
Patients following the standard preoperative policies of opur institution
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.
Prehabilitation
Patients following the standard preoperative policies of opur institution and the multimodal prehabilitation program
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. American Society of Anesthesiologist (ASA) index 3-4; and/or,
3. Peak oxygen uptake among 10-20 mL/kg/min.
Exclusion Criteria
2. Metastasic disease;
3. Unestable cardiac or respiratory condition; 4) Cognitive or locomotor limitations precluding the adherence to the program.
ALL
No
Sponsors
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Hospital Clinic of Barcelona
OTHER
Responsible Party
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Anael Barberan-Garcia
Principal investigator
Principal Investigators
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Anael Barberan-Garcia, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Locations
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Hospital Clínic de Barcelona
Barcelona, Catalonia, Spain
Countries
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Central Contacts
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Facility Contacts
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Anael Barberan-Garcia, PhD
Role: primary
References
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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.
Other Identifiers
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HCB/2018/1138
Identifier Type: -
Identifier Source: org_study_id