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Graft-versus-host-diseaseNCT06279585

Physical Therapy in Patients Undergoing Allo-HSCT With cGVHD

A study testing Physical therapy in people with Graft-versus-host-disease and Graft Versus Host Disease, Chronic, run by University of Seville at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) represents the only curative option for many patients diagnosed with various hematologic neoplasms. Procedure-related morbidity and mortality pose challenges to long-term outcomes and quality of life, especially among patients who develop chronic… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Physical therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteSpain
Study dates
1 Mar 2024to Sep 2025
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 chronic Graft-Versus-Host Disease (cGVHD) treated at Virgen del Rocío University Hospital will be invited to participate in the trial (n=108), under the following eligibility criteria: Inclusion criteria:
  • Adult (18 years or older); Underwent allogeneic hematopoietic stem cell transplantation (alloHSCT) diagnosed with cGVHD; No medical contraindication for moderate or high-intensity exercise; Proficiency in the Spanish language; Have access to the internet.

Who cannot join

  • Unable to perform initial or final physical assessments; Having serious pre-existing conditions before the oncological diagnosis or diseases that are not or poorly controlled; Not signing or delivering the informed consent on the indicated date.

Trial locations and contacts

1 site in 1 country.

Raquel P Aguilar, PhDcand contact

955 013 260 ext. +34

raquelijorml@gmail.com

José Antonio P Simón, PHD contact

955 013 260 ext. +34

josea.perez.simon.sspa@juntadeandalucia.es

Spain1 site

  • University of Seville; Manuel Siurot Avenue, no number

    Seville, 41013

    Raquel P Aguilar, Ph.D.cand., 955 013 260 ext. 34, raquelijorml@gmail.com

    José Antonio P Simón, PhD, 955 013 260 ext. 34, josea.perez.simon.sspa@juntadeandalucia.es

Other trials in Spain

About this study

Official title: Physical Therapy in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation With a Diagnosis of Chronic Graft-versus-host Disease: A Randomized Clinical Trial.

Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) represents the only curative option for many patients diagnosed with various hematologic neoplasms. Procedure-related morbidity and mortality pose challenges to long-term outcomes and quality of life, especially among patients who develop chronic graft-versus-host disease (cGVHD). There is a gap in healthcare that comprehensively addresses the specific needs of these patients. Physical therapy as an adjuvant treatment, through therapeutic exercise involving muscle strength and cardiorespiratory endurance, has shown positive influences on health markers and serves as a strong medical ally in similar profiles. Although these strategies could be reproducible and potentially beneficial for cGVHD patients, research has been limited to date, with the role of physical therapy possibly underutilized in this field. Justification: Unaddressed medical gap with no rigorously scientific responses specific to cGVHD. Objectives: This project aims to conduct the first randomized clinical trial from a physical therapy perspective as an adjuvant treatment for patients undergoing alloHSCT diagnosed with cGVHD.

Read the detailed description

Design: Prospective controlled clinical trial.

Location: Virgen del Rocío University Hospital, Hematology Unit.

Statistical analysis plan:The data will be analyzed using SPSS v.26 software for Windows and Epidat 4.2. All statistical tests will be conducted considering a 95% confidence interval (p-value <0.05). To compare the score of the main outcome measure, quality of life (score range 0-200), between the experimental and control groups, the t-test or Mann-Whitney test will be employed (depending on the normality of the data). The comparison will be conducted at three time points (T0, T1, and T2). Furthermore, multivariate analysis will be performed using generalized equations of repeated measures to determine score changes between the groups. Since it is a Likert scale-based score, the Friedman test will be used to compare score changes, employing the Bonferroni test for pairwise comparisons.

Being tested
Physical therapy
Keywords
Hematopoietic Stem Cell Transplantation, Graft versus host disease, Physiotherapy, Rehabilitation, Physical therapy, Exercise
Medical subject headings
Graft vs Host Disease, Bronchiolitis Obliterans Syndrome, Hematologic Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical therapyOther

    Health education sessions and combined therapeutic exercise sessions, based on muscular strength training and cardiorespiratory endurance.

Study groups in NCT06279585
Study groupRoleWhat they receive
Experimental groupExperimentalParticipants from both groups will undergo the three assessments and receive standard medical care.The patients in the experimental group will participate, at Time T1 (week 1 to 12), in a 12-week physiotherapy treatment program consisting of a total of 38 sessions: 2 health education sessions, 24 supervised combined exercise sessions, and 12 self-administered complementary exercise sessions.
Receives: Other: Physical therapy
Control groupNo interventionParticipants from both groups will undergo the three assessments and receive standard medical care. The Control Group (GC), externally to the trial itself, for ethical reasons, considering potential benefits without risks, and as a strategy for blinding the study itself, will carry out the physiotherapy treatment program following the final assessment of the study, becoming a hybrid program under the same protocol.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Health-related quality of life

    MEASURE NAME: Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT); VERSION: 4; NUMBER OF ITEMS: 50; RESPONSE SCALE: 5 point Likert-type scale; SCORING:Manual scoring template, some items are reverse scored. Higher score represents better quality of life.

    Measured: Week 1, Week 6, and Week 13

  2. Chronic Graft-Versus-Host Disease (cGVHD) symptom burden

    Modified Lee Chronic Graft-Versus-Host Disease Symptom Scale (mLSS) for 7 days. This is an instrument with 7 domains (skin, eyes, mouth, lungs, nutrition, energy, and psychiatry) and a total of 28 items to assess. The response options for "Please inform us if any of the following problems have bothered you in the last 7 days" range from 0 to 4 (Not at all, A little, Moderately, Quite a bit, Extremely). A difference of 5 to 6 points (standard deviation) will be considered clinically significant. Subscales range from 0 to 100, with a higher score indicating worse symptoms.

    Measured: Week 1, Week 6, and Week 13

Secondary outcomes (8)

  1. Muscular strength

    Sit-to- Stand test y Handrig strength test

    Measured: Week 1, Week 6, and Week 13

  2. Cardiorespiratory fitness

    2-min Walk Test

    Measured: Week 1, Week 6, and Week 13

  3. Functional status

    Human Activity Profile (HAP)

    Measured: Week 1, Week 6, and Week 13

  4. Distress

    Distress-Thermometer

    Measured: Week 1, Week 6, and Week 13

  5. Mood

    "Mood Assessment Scale" (MAS); Designed to assess transient mood states, both positive and negative, in any individual at any time, through 16 items divided into four scales (depression, anxiety, hostility, and joy), each defined by 4 items and evaluated using the Likert scale, with scores ranging from 0 to 10. The values for each category are calculated by the mean. All 16 statements have the same structure; they all begin with the phrase "I feel" and end with an adjective describing a mood state.

    Measured: Week 1, Week 6, and Week 13

  6. Anxiety

    Hospital Anxiety and Depression Scale (HADS) questionnaire; The "Hospital Anxiety and Depression Scale questionnaire" (HADS); a useful tool for identifying anxiety and depression states in cancer patients and applicable during clinical practice. The two categories consist of one subscale each, with seven items rated from 0 to 4 points, with higher scores (in the range of 0 to 21) indicating anxious and depressive states. Participants should respond considering how they felt and/or behaved during the last seven days.

    Measured: Week 1, Week 6, and Week 13

  7. Biological markers

    Cytokines (interleukins) and lymphocytic populations as part of routine analysis. Blood sample.

    Measured: Week 1, Week 6, and Week 13

  8. Responses to medical treatment

    NIH Criteria

    Measured: Week 1, Week 6, and Week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start1 Mar 2024 (estimated)
  3. Primary completionDec 2024 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06279585
Sponsor's protocol ID
ECA GVHD
Status last verified
Feb 2024
First submitted
28 Jan 2024
Last updated
28 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study protocol for a randomized clinical trial.

Questions about this trial

What is this clinical trial studying?

A study testing Physical therapy in people with Graft-versus-host-disease and Graft Versus Host Disease, Chronic, run by University of Seville 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 2 inclusion and 1 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 28 Feb 2024. 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 Raquel P Aguilar, PhDcand (955 013 260 ext. +34, raquelijorml@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health-related quality of life (time frame: Week 1, Week 6, and Week 13). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06279585.

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 28 Feb 2024.

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