IMpact of a Program of AerobiC Physical Exercise and Nutritional Therapy, on Quality of Life and Glycometabolic Compensation in Patients Undergoing Pancreatectomy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Improvement in quality of life
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 ≤18.5
研究组 & 干预措施
Performing Physical Exercise
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.
干预措施: Physical Aerobic Exercise (Behavioral)
Control
Subjects will undergo usual nutritional and endocrinological follow up after pancreatectomy. They will not perform any physical aerobic exercise.
结局指标
主要结局
Improvement in quality of life
时间窗: 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).
次要结局
- Detect changes in physical symptomps with the pancreas-specific PAN26 questionnaire.(12 months)
- Assessing changes in muscle power between subjects ongoing nutritional plan versus subjects ongoing nutritional plan and physical exercise(12 months)
- Detect changes in body mass index during the follow-up.(12 months)
研究者
Mezza Teresa
Dr.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS