GVHD,AcuteNCT05401955
Physiotherapy and Therapeutic Exercise Program in Graft-versus-host Disease (GvHD)
A study testing Physical exercise in people with GVHD,Acute and GVHD, Chronic, run by University of Salamanca at 1 site in Spain.
Trial summary
Range of motion, antropometric measurements, quality of life questionnaire and 2 minutes walk test will be implemented as an initial assessment. Physical exercise program will take 2 sessions a week for six months, and several follow-ups: before, during and after treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- GVHD,Acute, GVHD, Chronic
- What is being tested?
- Physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2022to 30 Jul 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Allogenic Transplantation patients with Graft versus host disease
Who cannot join
- Cognitive impairment
- Physical limitation from other pathologies
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University of Salamanca
Salamanca, 37007
Vicente Rodríguez, Ph.D., +34923294590 ext. 3162, vicente.rodriguez@usal.es
About this study
Official title: Effects of a Physical Therapy and Therapeutic Exercise Program in Graft-versus-host Disease (GVHD)
Range of motion, antropometric measurements, quality of life questionnaire and 2 minutes walk test will be implemented as an initial assessment.
Physical exercise program will take 2 sessions a week for six months, and several follow-ups: before, during and after treatment.
- Conditions
- GVHD,Acute, GVHD, Chronic
- Being tested
- Physical exercise
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseOther
An adapted physical exercise protocol
| Study group | Role | What they receive |
|---|---|---|
| Graft versus host disease Group | Experimental | Not described Receives: Other: Physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF36 Questionnaire
Quality of life
Measured: baseline and post-intervention (24 weeks)
2 minutes walk test
walking for 2 minutes without rest
Measured: baseline and post-intervention (24 weeks)
Hands strength
Dynamometer
Measured: baseline and post-intervention (24 weeks)
Active range of motion
P-ROM. Active ROM will be compared with standard pictures (1-4 points for lower limb and 1-7 points for upper limb)
Measured: baseline and post-intervention (24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 May 2022
- Primary completion10 May 2022
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GVHD,AcuteStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vicente Rodríguez Pérez, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401955
- Sponsor's protocol ID
- Interventional
- Status last verified
- May 2022
- First submitted
- 12 May 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Physical Therapy and Therapeutic Exercise Program in Graft-versus-host Disease (GVHD)
- ClinicalTrials.gov ID
- NCT05401955
- Acronym / sponsor ID
- Interventional
- Conditions
- GVHD,Acute, GVHD, Chronic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 2 Jun 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.
Range of motion, antropometric measurements, quality of life questionnaire and 2 minutes walk test will be implemented as an initial assessment.
Physical exercise program will take 2 sessions a week for six months, and several follow-ups: before, during and after treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Graft versus host disease Group | Experimental | Other: Physical exercise |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Allogenic Transplantation patients with Graft versus host disease
Key exclusion criteria (2 listed)
- Cognitive impairment
- Physical limitation from other pathologies
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 |
|---|---|---|
| Physical exerciseAn adapted physical exercise protocol | Other | Graft versus host disease Group |
Primary outcome
SF36 Questionnaire
Time frame: baseline and post-intervention (24 weeks)
Quality of life
2 minutes walk test
Time frame: baseline and post-intervention (24 weeks)
walking for 2 minutes without rest
Hands strength
Time frame: baseline and post-intervention (24 weeks)
Dynamometer
Active range of motion
Time frame: baseline and post-intervention (24 weeks)
P-ROM. Active ROM will be compared with standard pictures (1-4 points for lower limb and 1-7 points for upper limb)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise in people with GVHD,Acute and GVHD, Chronic, run by University of Salamanca 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 1 inclusion and 2 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 2 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF36 Questionnaire (time frame: baseline and post-intervention (24 weeks)). The study lists 4 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 2 Jun 2022.