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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05281250
Other study ID # PH-07
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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.

Study Design


Related Conditions & MeSH terms


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).
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