Diabetes, Malabsorption, Pancreatic Tumors
Conditions
Keywords
Pancreatectomy, Quality of Life, Physical Exercise
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.
Interventions
BEHAVIORALPhysical 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
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in quality of life | 12 months | Identify changes in the quality-of-life score from the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 (v3). The EORTC QLQ-C30 (v3) evaluates health status through nine multi-item scales: Five functional scales (physical, role, cognitive, emotional, social); three symptom scales (fatigue, pain, nausea/vomiting); one global health status scale. Additionally, six single-item scales assess symptoms commonly associated with neoplastic disease and its treatment (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detect changes in physical symptomps with the pancreas-specific PAN26 questionnaire. | 12 months | Assess possible changes in physical symptomps with the pancreas-specific PAN26 questionnaire. The PAN26 questionnaire consists of 26 four-level items, producing seven multi-item scale scores (each composed of two to four items) and nine single-item scores. |
| Assessing changes in muscle power between subjects ongoing nutritional plan versus subjects ongoing nutritional plan and physical exercise | 12 months | The subjects will be using their dominant hand, applies as much grip pressure as possible on the dynamometer. The assistant will record the maximum reading (kg). The subjects will repeat the test 3 times and the highest recorded value will be recorded to assess the subject's performance. |
| Detect changes in body mass index during the follow-up. | 12 months | At each follow-up visit, height (m) and weight (kg) will be recorded. BMI will then be measured as kg/m². |
Countries
Italy
Outcome results
None listed