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

Sponsor

Puerta de Hierro University Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT05281250

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Patients Hospitalized	Other: Supervised physical exercise	N/A

Detailed Description

The trial is not going to be runned

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Aug 28, 2018

Actual Primary Completion Date :

Aug 28, 2018

Actual Study Completion Date :

Aug 28, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Functional capacity [Through study completion (average 10 days)]
Functional Independence Measure (FIM)

Secondary Outcome Measures

Strength [Through study completion (average 10 days).]
Dynamometry
Cardiorespiratory condition [Through study completion (average 10 days)]
Six minute test .
Daily physical activity [Through study completion (average 10 days)]
Accelerometry during the hospitalization.
Fatigue-FACIT [Through study completion (average 10 days)]
FACIT Fatigue Scale
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)
Length of hospital stay [Through study completion (average 10 days).]
Number of days the patient is hospitalized.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid	Spain	28222

Sponsors and Collaborators

Puerta de Hierro University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ana Ruiz-Casado, Medical Oncologist, Puerta de Hierro University Hospital

ClinicalTrials.gov Identifier:

NCT05281250

Other Study ID Numbers:

PH-07

First Posted:

Mar 16, 2022

Last Update Posted:

Mar 16, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ana Ruiz-Casado, Medical Oncologist, Puerta de Hierro University Hospital

rehabilitation

physical activity

Physical condition

Study Results

No Results Posted as of Mar 16, 2022