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Clinical Trials in Italy / NCT06858631
Active, not recruiting Not applicable

IMPact of AerobiC Exercise in Addition to Nutritional Treatment on Quality of Life After Pancreatectomy

NCT06858631 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-01-01
Last updated
2025-03-05

Condition(s) studied

Pancreatic TumorsDiabetesMalabsorption

Investigational drug(s) / intervention(s)

Physical Aerobic Exercise

Physical Aerobic Exercise: 30-minute net aerobic exercise sessions at moderate intensity (3-5 METS, 60%-70% of maximum heart rate) three times per week. Walking, cycling, or swimming, with the option to alternate activities to enhance adherence to the program. Each session will include 10 minutes of warm-up (gradual increase in intensity); 30 minutes of aerobic exercise and 10 minutes of cool-down (gradual reduction of intensity and optional stretching). Total weekly exercise duration will be 150 minutes

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome RM

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06858631 on ClinicalTrials.gov ↗ ← All trials in Italy