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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pancreatic Tumors Diabetes Malabsorption

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Physical Aerobic Exercise

Intervention Type 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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physical 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

Intervention Type BEHAVIORAL

Other Intervention Names

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Physical activity

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No