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Active, Not Recruiting

NCT Number: NCT06858631

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pancreatic Tumors Behavior Diabetes Diabetes Mellitus Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Glucose Metabolism Disorders Intestinal Diseases Malabsorption Malabsorption Syndromes Metabolic Diseases Motor Activity Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, RM, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Aerobic Exercise

Behavioral

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

Other names: Physical activity

Primary outcomes

  1. Improvement in quality of life

    Time frame: 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 outcomes

  1. Detect changes in physical symptomps with the pancreas-specific PAN26 questionnaire.

    Time frame: 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.

  2. Assessing changes in muscle power between subjects ongoing nutritional plan versus subjects ongoing nutritional plan and physical exercise

    Time frame: 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.

  3. Detect changes in body mass index during the follow-up.

    Time frame: 12 months

    At each follow-up visit, height (m) and weight (kg) will be recorded. BMI will then be measured as kg/m².

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: IMPACT

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Mar 5, 2025
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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