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

NCT05281250 | Withdrawn

• 1 other identifier: PH-07
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Patients; Hospitalized

Keywords

rehabilitation; physical activity; Physical condition

Outcome Measures

Primary Outcomes (1)

• Functional capacity

  Functional Independence Measure (FIM)

  Through study completion (average 10 days)

Secondary Outcomes (8)

• Strength

  Through study completion (average 10 days).

• Cardiorespiratory condition

  Through study completion (average 10 days)

• Daily physical activity

  Through study completion (average 10 days)

• Fatigue-FACIT

  Through study completion (average 10 days)

• Fatigue-PERFORM

  Through study completion (average 10 days)

Study Arms (2)

Supervised physical exercise

EXPERIMENTAL

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

Other: Supervised physical exercise

Control

NO INTERVENTION

Patients will receive recommendations about exercising during hospitalization.

Interventions

Supervised physical exercise OTHER

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.

Supervised physical exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Puerta de Hierro University Hospital: lead

Study Sites (1)

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Ana Ruiz Casado

  Puerta de Hierro University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: March 16, 2022
• Study Start: August 28, 2018
• Primary Completion: August 28, 2018
• Study Completion: August 28, 2018
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)