Cancer Patients Clinical Trial
— EFFAPROOfficial 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)
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Status | Withdrawn |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 |
Verified date | March 2022 |
Source | Puerta de Hierro University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Puerta de Hierro | Majadahonda | Madrid |
Lead Sponsor | Collaborator |
---|---|
Puerta de Hierro University Hospital |
Spain,
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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