Evaluation of Physical Exercise to Prevent Functional Deterioration During Hospitalization (EFFAPRO)

Study Overview
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Brief Summary
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This is a randomized study that will measure the possible benefit of supervised training during the hospitalization of patients with stage IV neoplasms in active treatment.

Detailed Description
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The trial is not going to be runned

Official Title
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Evaluation of Physical Exercise as a Protective Factor for the Loss of Functional Capacity in Patients With Metastatic Tumors During Hospitalization. Pilot Study (EFFAPRO)

Conditions
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Cancer Patients, Hospitalized

Intervention / Treatment
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* Other: Supervised physical exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with stage IV neoplasms. Active treatment: chemotherapy, hormone therapy, immunotherapy or targeted therapies. Hospitalization at Medical Oncology Departmentof the Hospital Puerta de Hierro. Reason for hospitalization is expected to be solved in less than two weeks. Exclusion Criteria: Patients who do not wish to participate. Cognitive impairment. Hospitalization due to progression of oncological disease. Acute coronary syndrome or bone fracture in limbs during the previous three months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised physical exercise<br>Supervised exercise (aerobic + strength + flexibility) depending on the functional capacity of each patient, during hospitalization | Other: Supervised physical exercise<br>* A supervised exercise is randomized. Although this intervention is not standard in our setting, it is a recommended practice, since it is known that rehabilitation strategies in hospitalized patients have different benefits.<br>|
| No Intervention: Control<br>Patients will receive recommendations about exercising during hospitalization. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional capacity | Functional Independence Measure (FIM) | Through study completion (average 10 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strength | Dynamometry | Through study completion (average 10 days). | 
| Cardiorespiratory condition | Six minute test . | Through study completion (average 10 days) | 
| Daily physical activity | Accelerometry during the hospitalization. | Through study completion (average 10 days) | 
| Fatigue-FACIT | FACIT Fatigue Scale | Through study completion (average 10 days) | 
| Fatigue-PERFORM | PERFORM Fatigue questionnaire (12-60) Higher, better (less fatigue) | Through study completion (average 10 days) | 
| Life quality: Q30 questionnaire | QLQ30 questionnaire (quality of life). 0-100 (HIGHER, better) | Through study completion (average 10 days) | 
| Anxiety and depression | HADS questionnaire (anxiety and depression). 0-42 (less better) | Through study completion (average 10 days) | 
| Length of hospital stay | Number of days the patient is hospitalized. | Through study completion (average 10 days). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, physical activity, Physical condition