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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Active, not recruiting

Conditions: Diabetes; Malabsorption; Pancreatic Tumors

Treatments: Behavioral: Physical Aerobic Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06858631

6706

Details and patient eligibility

About

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.

Enrollment: 38 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

38 participants in 2 patient groups

Performing Physical Exercise

Experimental group

Description:

Subjects will perferm 30-minute net aerobic exercise sessions at moderate intensity (3-5 METS, 60%-70% of maximum heart rate) three times per week. Participants may choose from 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.

Treatment:

Behavioral: Physical Aerobic Exercise

Control

No Intervention group

Description:

Subjects will undergo usual nutritional and endocrinological follow up after pancreatectomy. They will not perform any physical aerobic exercise.