Clinical trial NCT06858631: IMPact of AerobiC Exercise in Addition to Nutritional Treatment on Quality of Life After Pancreatectomy
Official title: IMpact of a Program of AerobiC Physical Exercise and Nutritional Therapy, on Quality of Life and Glycometabolic Compensation in Patients Undergoing Pancreatectomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pancreatic Tumors
Diabetes
Malabsorption
Keywords: Pancreatectomy
Quality of Life
Physical Exercise
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this interventional study is to assess the impact of a 6-month unsupervised aerobic exercise program on the quality of life of patients undergoing partial or total pancreatectomy. The main question it aims to answer is:

Does an aerobic exercise program improve physical functioning and overall quality of life in post-pancreatectomy patients?

Eligible participants will be assigned to either an exercise group or a control group. Quality of life will be evaluated using standardized scoring scales, with a focus on physical functioning. Secondary outcomes include changes in metabolic parameters (glycemia, HbA1c, lipid profile), BMI, and overall survival.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Male or female patients who have undergone partial or total pancreatectomy
* Age ≥18 and ≤80 years
* Ability to understand and complete questionnaires and willingness to participate in periodic assessments
* No symptoms suggestive of cardiovascular issues (e.g., angina, dyspnea, palpitations, syncope)
* No evidence of ischemic heart disease, cardiomyopathy, valvular heart disease, myocarditis, autoimmune diseases, infections, or fractures that would contraindicate moderate-intensity aerobic activity

Exclusion Criteria:

* Age \>80 or \<18 years
* Cardiovascular, musculoskeletal, rheumatologic, or neurocognitive disorders contraindicating aerobic exercise
* 10-year cardiovascular risk \>20% without cardiological/sports medicine evaluation
* Diagnosis of unresectable tumor
* Presence of metastases
* Pregnancy or breastfeeding
* Ongoing chemotherapy and/or radiotherapy
* BMI ≥30
* BMI ≤18.5

Primary outcomes:
measure: Improvement in quality of life
timeFrame: 12 months
Secondary outcomes:
measure: Detect changes in physical symptomps with the pancreas-specific PAN26 questionnaire.
timeFrame: 12 months
measure: Assessing changes in muscle power between subjects ongoing nutritional plan versus subjects ongoing nutritional plan and physical exercise
timeFrame: 12 months
measure: Detect changes in body mass index during the follow-up.
timeFrame: 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
state: RM
Study officials:
References:
citation: Katsourakis A, Vrabas I, Papanikolaou V, Apostolidis S, Chatzis I, Noussios G. The Role of Exercise in the Quality of Life in Patients After Pancreatectomy: A Prospective Randomized Controlled Trial. J Clin Med Res. 2019 Jan;11(1):65-71. doi: 10.14740/jocmr3675. Epub 2018 Dec 3.
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citation: Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.
citation: Rock CL, Thomson CA, Sullivan KR, Howe CL, Kushi LH, Caan BJ, Neuhouser ML, Bandera EV, Wang Y, Robien K, Basen-Engquist KM, Brown JC, Courneya KS, Crane TE, Garcia DO, Grant BL, Hamilton KK, Hartman SJ, Kenfield SA, Martinez ME, Meyerhardt JA, Nekhlyudov L, Overholser L, Patel AV, Pinto BM, Platek ME, Rees-Punia E, Spees CK, Gapstur SM, McCullough ML. American Cancer Society nutrition and physical activity guideline for cancer survivors. CA Cancer J Clin. 2022 May;72(3):230-262. doi: 10.3322/caac.21719. Epub 2022 Mar 16.