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

Not Applicable

Withdrawn

• Conditions: Cancer Patients; Hospitalized
• Interventions: Other: Supervised physical exercise

• Registration Number: NCT05281250
• Lead Sponsor: Puerta de Hierro University Hospital

Brief Summary

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

The trial is not going to be runned

Study Timeline

• Study First Submitted: 2018-08-27
• Study Start: 2018-08-28
• Primary Completion: 2018-08-28
• Study Completion: 2018-08-28
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-04
• Last Update Submitted: 2022-03-04
• Study First Posted: 2022-03-16
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supervised physical exercise	Supervised physical exercise	Supervised exercise (aerobic + strength + flexibility) depending on the functional capacity of each patient, during hospitalization

Primary Outcome Measures

Name	Time	Method
Functional capacity	Through study completion (average 10 days)	Functional Independence Measure (FIM)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Universitario Puerta de Hierro; 🇪🇸 Majadahonda, Madrid, Spain