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

Cancer Patients Clinical Trial

— EFFAPRO  

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05281250
• Other study ID #: PH-07
• Status: Withdrawn
• Phase: N/A
• Start date: August 28, 2018
• Est. completion date: August 28, 2018

Study information

• Verified date: March 2022
• Source: Puerta de Hierro University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The trial is not going to be runned

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 28, 2018
• Est. primary completion date: August 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Patients
• Hospitalized

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Puerta de Hierro University Hospital

Country where clinical trial is conducted

Spain, 

Outcome

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