Cancer PatientsEFFAPRONCT05281250
Evaluation of Physical Exercise to Prevent Functional Deterioration During Hospitalization (EFFAPRO)
A study testing Supervised physical exercise in people with Cancer Patients and Hospitalized, run by Puerta de Hierro University Hospital at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Patients, Hospitalized
- What is being tested?
- Supervised physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 28 Aug 2018to 28 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Conditions
- Cancer Patients, Hospitalized
- Being tested
- Supervised physical exercise
- Keywords
- rehabilitation, physical activity, Physical condition
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised physical exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Supervised physical exercise | Experimental | Supervised exercise (aerobic + strength + flexibility) depending on the functional capacity of each patient, during hospitalization Receives: Other: Supervised physical exercise |
| Control | No intervention | Patients will receive recommendations about exercising during hospitalization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
Functional Independence Measure (FIM)
Measured: Through study completion (average 10 days)
Secondary outcomes (8)
Strength
Dynamometry
Measured: Through study completion (average 10 days).
Cardiorespiratory condition
Six minute test .
Measured: Through study completion (average 10 days)
Daily physical activity
Accelerometry during the hospitalization.
Measured: Through study completion (average 10 days)
Fatigue-FACIT
FACIT Fatigue Scale
Measured: Through study completion (average 10 days)
Fatigue-PERFORM
PERFORM Fatigue questionnaire (12-60) Higher, better (less fatigue)
Measured: Through study completion (average 10 days)
Life quality: Q30 questionnaire
QLQ30 questionnaire (quality of life). 0-100 (HIGHER, better)
Measured: Through study completion (average 10 days)
Anxiety and depression
HADS questionnaire (anxiety and depression). 0-42 (less better)
Measured: Through study completion (average 10 days)
Length of hospital stay
Number of days the patient is hospitalized.
Measured: Through study completion (average 10 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start28 Aug 2018
- Primary completion28 Aug 2018
- Study completion28 Aug 2018
Why it stopped: structural change at the hospital
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Puerta de Hierro University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Ruiz-Casado, Puerta de Hierro University Hospital
- Investigators
- Ana Ruiz Casado, Principal investigator, Puerta de Hierro University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281250
- Sponsor's protocol ID
- PH-07
- Acronym
- EFFAPRO
- Status last verified
- Mar 2022
- First submitted
- 27 Aug 2018
- Last updated
- 16 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05281250
- Acronym / sponsor ID
- EFFAPRO / PH-07
- Conditions
- Cancer Patients, Hospitalized
- Keywords
- rehabilitation, physical activity, Physical condition
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: structural change at the hospital
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Puerta de Hierro University HospitalUniversity, hospital or other
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 28 Aug 2018 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The trial is not going to be runned
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised physical exercise | Experimental | Other: Supervised physical exerciseSupervised exercise (aerobic + strength + flexibility) depending on the functional capacity of each patient, during hospitalization |
| Control | No intervention | –Patients will receive recommendations about exercising during hospitalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised physical exerciseA 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. | Other | Supervised physical exercise |
Primary outcome
Functional capacity
Time frame: Through study completion (average 10 days)
Functional Independence Measure (FIM)
8 secondary outcomes
Strength
Time frame: Through study completion (average 10 days).
Cardiorespiratory condition
Time frame: Through study completion (average 10 days)
Daily physical activity
Time frame: Through study completion (average 10 days)
Fatigue-FACIT
Time frame: Through study completion (average 10 days)
Fatigue-PERFORM
Time frame: Through study completion (average 10 days)
Life quality: Q30 questionnaire
Time frame: Through study completion (average 10 days)
Anxiety and depression
Time frame: Through study completion (average 10 days)
Length of hospital stay
Time frame: Through study completion (average 10 days).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Cancer Patients
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Ruiz Casado principal investigator
Puerta de Hierro University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised physical exercise in people with Cancer Patients and Hospitalized, run by Puerta de Hierro University Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity (time frame: Through study completion (average 10 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.