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NCT06858631Active, not recruiting

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

IMpact of a Program of AerobiC Physical Exercise and Nutritional Therapy, on Quality of Life and Glycometabolic Compensation in Patients Undergoing Pancreatectomy

Source: ClinicalTrials.gov · Last updated 5 Mar 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
38 (estimated)
First submitted
24 Feb 2025
Start date
1 Jan 2025
Primary completion date
31 Dec 2025
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NCT number
NCT06858631

What you commit to

  • Study type: Interventional
  • Planned participants: 38
  • From 1 Jan 2025 to the primary completion date, 31 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Ongoing chemotherapy and/or radiotherapy

Other illness

  • Cardiovascular, musculoskeletal, rheumatologic, or neurocognitive disorders contraindicating aerobic exercise

Age

  • Age \>80 or \<18 years

Other

  • 10-year cardiovascular risk \>20% without cardiological/sports medicine evaluation
  • Diagnosis of unresectable tumor
  • Presence of metastases
  • Pregnancy or breastfeeding
  • BMI ≥30
  • BMI ≤18.5

Who the study is looking for

  • 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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Coordinator of this site? Confirm its status
RomeItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.