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WithdrawnNCT05281250EFFAPROUpdated Mar 16, 2022

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

An interventional study of Supervised physical exercise in Cancer Patients and Hospitalized, sponsored by Puerta de Hierro University Hospital. Withdrawn at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-16.

Sponsored by Puerta de Hierro University Hospital · Not applicable, Interventional, and Supportive care

Why this study was withdrawn
structural change at the hospital
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

The trial is not going to be runned

02

Conditions studied

  • Cancer Patients
  • Hospitalized

Keywords

  • rehabilitation
  • physical activity
  • Physical condition
03

In context

Lead sponsor

Puerta de Hierro University Hospital is the lead sponsor of 48 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Supervised physical exercise

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

    Other: Supervised physical exercise

  • No intervention
    Control

    Patients will receive recommendations about exercising during hospitalization.

Interventions

  • OtherSupervised 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.

06

What researchers measure

Primary outcomes

  1. Functional capacity

    Functional Independence Measure (FIM)

    Time frame: Through study completion (average 10 days)

Secondary outcomes

  1. Strength

    Dynamometry

    Time frame: Through study completion (average 10 days).

  2. Cardiorespiratory condition

    Six minute test .

    Time frame: Through study completion (average 10 days)

  3. Daily physical activity

    Accelerometry during the hospitalization.

    Time frame: Through study completion (average 10 days)

  4. Fatigue-FACIT

    FACIT Fatigue Scale

    Time frame: Through study completion (average 10 days)

  5. Fatigue-PERFORM

    PERFORM Fatigue questionnaire (12-60) Higher, better (less fatigue)

    Time frame: Through study completion (average 10 days)

  6. Life quality: Q30 questionnaire

    QLQ30 questionnaire (quality of life). 0-100 (HIGHER, better)

    Time frame: Through study completion (average 10 days)

  7. Anxiety and depression

    HADS questionnaire (anxiety and depression). 0-42 (less better)

    Time frame: Through study completion (average 10 days)

  8. Length of hospital stay

    Number of days the patient is hospitalized.

    Time frame: Through study completion (average 10 days).

07

Study locations

1 site
  • Hospital Universitario Puerta de Hierro
    Majadahonda, Madrid 28222, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05281250
Lead sponsor
Puerta de Hierro University Hospital
Responsible party
Ana Ruiz-Casado (Medical Oncologist, Puerta de Hierro University Hospital) — Principal investigator
First posted
Mar 16, 2022
Start date
Aug 28, 2018
Primary completion
Aug 28, 2018
Completion
Aug 28, 2018
Last update
Mar 16, 2022

Study contacts

Ana Ruiz Casado
principal investigator · Puerta de Hierro University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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