Hematologic MalignancyTRASNCT02193399
Physiotherapy in Hematopoietic Stem Cell Transplantation
A study testing Physiotherapy in patients with stem cell transplantation in people with Hematologic Malignancy and Stem Cell Transplantation, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Research project with patients undergoing allogeneic hematopoietic transplantation in the hematology and hemotherapy Clinical Hospital Universitario Virgen de la Arrixaca. The main objective is to assess the differences in skeletal muscle and functional variables in the experimental group underwent a physiotherapy… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hematologic Malignancy, Stem Cell Transplantation
- What is being tested?
- Physiotherapy in patients with stem cell transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2014to Sep 2016
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 70 years.
- Patients with a diagnosis of hematologic malignancy that will be subjected to hematopoietic transplantation.
- Patients offer sufficient guarantee adherence to protocol.
- Patients who have previously signed informed consent.
Who cannot join
- Patients with inability to walk, before treatment.
- Patients whose medical judgment contraindicated inclusion in a physiotherapy intervention.
- Patients with psychotic traits, brain damage or senility prevention of the correct understanding of physical therapy.
- Patients with inability to sign informed consent or understanding.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Murcia, 30120
RUBÉN CUESTA-BARRIUSO, PhD, 968278806, ruben.cuestab@gmail.com
JORGE MONTSERRAT COLL, MD, 968369532, jorge.monserrat@carm.es
About this study
Official title: Effectiveness of Physiotherapy in the Prevention of Physical Sequelae in Patients Treated With Hematopoietic Stem Cell Transplantation. A Pilot Study.
Research project with patients undergoing allogeneic hematopoietic transplantation in the hematology and hemotherapy Clinical Hospital Universitario Virgen de la Arrixaca. The main objective is to assess the differences in skeletal muscle and functional variables in the experimental group underwent a physiotherapy treatment that takes place during the pre-and post-transplant period, compared to a control group.
Read the detailed description
The main characteristics of the study are:
- Randomized, prospective and longitudinal in patients receiving allogeneic hematopoietic stem cell transplantation clinical trial.
- A descriptive study of skeletal muscle characteristics of patients undergoing allogeneic hematopoietic transplantation for hematologic malignancies before and after carrying out a treatment with stem cells.
- Clinical study of the variables of strength, mobility, proprioception and upper and lower pain in patients with hematologic malignancy member before and after cancer treatment.
- Clinical study of the effectiveness of physiotherapy treatment in clinical characteristics (strength, mobility, proprioception and pain) in patients undergoing allogeneic stem cell transplantation.
- Clinical study of psychosocial variables that are affected by hematological treatment, and the influence on them of a physiotherapy treatment.
The data obtained in this project to identify and treat those functional deficits that appear as a result of cancer treatment and influencing patients, regarding the evolution of the disease and its treatment. They will use different psychosocial questionnaires and functional tests based on scientific evidence and the reliability of these, as well as its specific design for patients with hematologic cancer.
- Conditions
- Hematologic Malignancy, Stem Cell Transplantation
- Being tested
- Physiotherapy in patients with stem cell transplantation
- Keywords
- Stem cell transplantation, Fatigue, Physiotherapy, Quality of Life, Cancer, Psychosocial aspects
- Medical subject headings
- Hematologic Neoplasms, Fatigue, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy in patients with stem cell transplantationOther
The exercises are repeated in both upper limbs and both lower limbs. All exercises are performed with specific respiratory exercises simultaneously the movement that takes place each year form.
The exercises are carried out by the physiotherapist applying in a passive way (ascending or descending) progressive strength and degree of difficulty and variables depending on the clinical condition of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy exercises | Experimental | Strength exercises for the muscles proximal upper limbs and lower limbs and proprioception exercises Receives: Other: Physiotherapy in patients with stem cell transplantation |
| Control group | No intervention | Patients undergoing allogeneic transplantation without treatment of physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in joint range of motion
Will be evaluated with a universal goniometer following validated protocols of measurement
Measured: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days)
Changes in muscle strength of quadriceps, the gastrocnemius and biceps
It is measured with the scale of Daniels and a dynamometer.
Measured: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Changes in proprioception
It is measured with a balance platform and supports uni and bipodal
Measured: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Changes in pain perception
It will be evaluated with the visual analogue scale and algometer
Measured: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Changes in the perception of fatigue
Using the Spanish version of the Brief Fatigue Inventory
Measured: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Changes in body mass
By using the measurement tool TANITA calculate bone, muscle and fat mass, as well as the amount of fluid of patients at each evaluation.
Measured: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Changes in the perception of quality of life
Using the self-questionnaire SF-36 health
Measured: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Changes in the profile of disease consequences
Using the questionnaire Sickness Impact Profile (SIP)
Measured: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Changes in coping with the disease
Using the scale questionnaire Mental Adjustment to Cancer
Measured: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Change in perception of anxiety
Using the STAI questionnaire
Measured: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Hematopoietic recovery
Measuring the rate of graft failure and the transfusion dependence
Measured: After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Secondary outcomes (7)
Response to the transplantation
By analyzing the rate and type of response
Measured: After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Infectious complications
By measuring the rate, type and severity of infections
Measured: After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Noninfectious complications
Measuring the rate of EVOH (number and percentage)
Measured: After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Immunological recovery
By measuring the number and percentage of B lymphocytes, T lymphocytes and NK lymphocytes.
Measured: after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Hospitalisations of the patient after transplantation
Measuring the number of hospitalizations, the number of days in hospital and the cause of same
Measured: after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Socio-demographic variables
Gender (male, female), academic education (university education, basic education, vocational training), marital status (single, married, divorced, widowed), employment status (self-employed, employed as an employee, unemployed) and distance to hospital (km)
Measured: Screening visit (one month before hospital admission)
Clinical variables
Medical diagnosis, age (years), height (cm), weight (kg)
Measured: Screening visit (one month before hospital admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RUBÉN CUESTA-BARRIUSO, Universidad Católica San Antonio de Murcia
- Investigators
- JORGE MONTSERRAT COLL, MD, Principal investigator, Hospital Universitario Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193399
- Sponsor's protocol ID
- TRASFIS
- Other IDs
- TRAS
- Acronym
- TRAS
- Status last verified
- Jun 2014
- First submitted
- 15 Jul 2014
- Last updated
- 29 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Physiotherapy in the Prevention of Physical Sequelae in Patients Treated With Hematopoietic Stem Cell Transplantation. A Pilot Study.
- ClinicalTrials.gov ID
- NCT02193399
- Acronym / sponsor ID
- TRAS / TRASFIS
- Conditions
- Hematologic Malignancy, Stem Cell Transplantation
- Keywords
- Stem cell transplantation, Fatigue, Physiotherapy, Quality of Life, Cancer, Psychosocial aspects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 17 Jul 2014 (estimated)
- 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.
Research project with patients undergoing allogeneic hematopoietic transplantation in the hematology and hemotherapy Clinical Hospital Universitario Virgen de la Arrixaca. The main objective is to assess the differences in skeletal muscle and functional variables in the experimental group underwent a physiotherapy treatment that takes place during the pre-and post-transplant period, compared to a control group.
Detailed description
The main characteristics of the study are:
- Randomized, prospective and longitudinal in patients receiving allogeneic hematopoietic stem cell transplantation clinical trial.
- A descriptive study of skeletal muscle characteristics of patients undergoing allogeneic hematopoietic transplantation for hematologic malignancies before and after carrying out a treatment with stem cells.
- Clinical study of the variables of strength, mobility, proprioception and upper and lower pain in patients with hematologic malignancy member before and after cancer treatment.
- Clinical study of the effectiveness of physiotherapy treatment in clinical characteristics (strength, mobility, proprioception and pain) in patients undergoing allogeneic stem cell transplantation.
- Clinical study of psychosocial variables that are affected by hematological treatment, and the influence on them of a physiotherapy treatment.
The data obtained in this project to identify and treat those functional deficits that appear as a result of cancer treatment and influencing patients, regarding the evolution of the disease and its treatment. They will use different psychosocial questionnaires and functional tests based on scientific evidence and the reliability of these, as well as its specific design for patients with hematologic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy exercises | Experimental | Other: Physiotherapy in patients with stem cell transplantationStrength exercises for the muscles proximal upper limbs and lower limbs and proprioception exercises |
| Control group | No intervention | –Patients undergoing allogeneic transplantation without treatment of physiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged between 18 and 70 years.
- Patients with a diagnosis of hematologic malignancy that will be subjected to hematopoietic transplantation.
- Patients offer sufficient guarantee adherence to protocol.
- Patients who have previously signed informed consent.
Key exclusion criteria (4 listed)
- Patients with inability to walk, before treatment.
- Patients whose medical judgment contraindicated inclusion in a physiotherapy intervention.
- Patients with psychotic traits, brain damage or senility prevention of the correct understanding of physical therapy.
- Patients with inability to sign informed consent or understanding.
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 |
|---|---|---|
| Physiotherapy in patients with stem cell transplantationThe exercises are repeated in both upper limbs and both lower limbs. All exercises are performed with specific respiratory exercises simultaneously the movement that takes place each year form. The exercises are carried out by the physiotherapist applying in a passive way (ascending or descending) progressive strength and degree of difficulty and variables depending on the clinical condition of the patient. | Other | Physiotherapy exercises |
Primary outcome
Changes in joint range of motion
Time frame: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days)
Will be evaluated with a universal goniometer following validated protocols of measurement
Changes in muscle strength of quadriceps, the gastrocnemius and biceps
Time frame: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
It is measured with the scale of Daniels and a dynamometer.
Changes in proprioception
Time frame: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
It is measured with a balance platform and supports uni and bipodal
Changes in pain perception
Time frame: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
It will be evaluated with the visual analogue scale and algometer
Changes in the perception of fatigue
Time frame: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Using the Spanish version of the Brief Fatigue Inventory
Changes in body mass
Time frame: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
By using the measurement tool TANITA calculate bone, muscle and fat mass, as well as the amount of fluid of patients at each evaluation.
Changes in the perception of quality of life
Time frame: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Using the self-questionnaire SF-36 health
Changes in the profile of disease consequences
Time frame: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Using the questionnaire Sickness Impact Profile (SIP)
Changes in coping with the disease
Time frame: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Using the scale questionnaire Mental Adjustment to Cancer
Change in perception of anxiety
Time frame: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Using the STAI questionnaire
Hematopoietic recovery
Time frame: After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Measuring the rate of graft failure and the transfusion dependence
7 secondary outcomes
Response to the transplantation
Time frame: After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Infectious complications
Time frame: After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Noninfectious complications
Time frame: After hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Immunological recovery
Time frame: after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Hospitalisations of the patient after transplantation
Time frame: after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days).
Socio-demographic variables
Time frame: Screening visit (one month before hospital admission)
Clinical variables
Time frame: Screening visit (one month before hospital admission)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
Related trials for Hematologic Malignancy
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
Active, not recruitingObservational study
Gulf Long-Term Follow-Up Study
Cardiovascular Disease, Hematologic Diseases
RecruitingPhase 3
Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)
Solid Tumors, Hematologic Malignancies
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
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.
JORGE MONTSERRAT COLL, MD principal investigator
Hospital Universitario Virgen de la Arrixaca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in patients with stem cell transplantation in people with Hematologic Malignancy and Stem Cell Transplantation, run by Universidad Católica San Antonio de Murcia 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: status not confirmed, as of the sponsor's last update on 29 Aug 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact RUBÉN CUESTA-BARRIUSO, PhD (968278806, ruben.cuestab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in joint range of motion (time frame: Screening visit (one month before hospital admission); at the time of admission (±3 days); ±2 days before transplantation; after hospital discharge (± 3 days); and at 3 and 6 months after transplantation (± 3 days)). The study lists 11 primary outcomes in all. 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 29 Aug 2014; AzTrials last refreshed its copy on 30 Oct 2026.