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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cancer Patients; Hospitalized
• Intervention / Treatment: Other: Supervised physical exercise

Detailed Description

The trial is not going to be runned

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supervised physical exercise; Supervised exercise (aerobic + strength + flexibility) depending on the functional capacity of each patient, during hospitalization	Other: Supervised physical exercise; 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.
No Intervention: Control; Patients will receive recommendations about exercising during hospitalization.

What is the study measuring?

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).

Collaborators and Investigators

• Sponsor: Puerta de Hierro University Hospital
• Investigators: Principal Investigator: Ana Ruiz Casado, Puerta de Hierro University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2018
• Primary Completion (Actual): August 28, 2018
• Study Completion (Actual): August 28, 2018

Study Registration Dates

• First Submitted: August 27, 2018
• First Submitted That Met QC Criteria: March 4, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 4, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: physical activity; rehabilitation; Physical condition
• Other Study ID Numbers: PH-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No