Hematopoietic Stem Cell TransplantNCT06692478
Benefits of Intrahospital Exercise Program in Pediatric HSCT
A study testing Exercise regimen in people with Hematopoietic Stem Cell Transplant and Pediatric Cancer, run by Phoenix Children's Hospital at 1 site in United States.
Trial summary
This randomized control study examines the effect of an intrahospital exercise regimen on the physical deconditioning that occurs due to hematopoietic stem cell transplant in the pediatric population. Read more about this study
- Who is it for?
- Ages 4 to 21 years
- Conditions the study is for
- Hematopoietic Stem Cell Transplant, Pediatric Cancer, Deconditioning
- What is being tested?
- Exercise regimen
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 1 Oct 2019
- 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 4 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients ages 4-21 years of age who present for hematopoietic stem cell transplant.
- Karnofsky (if ≥16 years) or Lansky (if <16 years) score >60 at enrollment and prior to each testing point
- Parental/guardian permission (informed consent) and child assent prior to transplant.
Who cannot join
- Patients with any preexisting need for gait assistance such as crutches, wheelchair, braces, or walker
- Previous stem cell transplant in the last 6 months
- Patients with grade 3 or greater sensory/motor neuropathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefits of Intrahospital Exercise Program in Pediatric Hematopoietic Stem Cell Transplant-A Randomized Control Trial
This randomized control study examines the effect of an intrahospital exercise regimen on the physical deconditioning that occurs due to hematopoietic stem cell transplant in the pediatric population.
- Being tested
- Exercise regimen
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise regimenBehavioural
Age 4-6 years: Target lower extremity, core and upper extremity strengthening and activity tolerance. With supervision by the PT, the patient will walk in their room, and complete the following through play: squat, single leg stance, climb onto couch, half kneel to stand, quadruped and tall kneeling.
Age 7-21 years: First component will be strengthening exercises completed in bed or on a mat while sitting or standing. Multiple levels of exercises will be available, so that the program can be tailored to each patient and to their ability to perform activities. The exercises included will focus on core, hip musculature, and upper extremity strengthening; including exercises in quadruped and prone positioning, as well as supine, sitting and standing. Thera-Band will be used to increase resistance as needed. The second component will be endurance. Since the patients will be confined to their room this will include ambulation within the room, recumbent or pedal exerciser and step ups.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | This structured exercise program will incorporate a specially designed, low intensity, resistance based exercise regime created by our physical therapist. In addition to standard of care, it consists of strengthening, endurance, stretching and relaxation exercises tailored according to age and their ability to perform activities throughout their hospitalization. This exercise program will be done three times a week for 30-45 mins supervised by the same physiotherapist throughout hospitalization and will be self-administered every weekend. A home exercise program printout with the appropriate resistance exercises will be provided to the family upon discharge, with instructions on how often to complete throughout the week. Discharged children will attend one supervised exercise session per week with the physiotherapist for six weeks. The family and patient will also be provided a weekly sheet to check off the days they completed strengthening and endurance exercises. Receives: Behavioral: Exercise regimen |
| Standard of Care | No intervention | The second arm of the study involves patients following standard of care during the HSCT period in the hospital with PT evaluation and management prescribed as needed by their transplant medical team including any additional PT interventions as a result of clinical indications. No additional intervention is incorporated in this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline 6-minute walk test at 6 weeks discharge.
Test of Endurance (Pre-transplant, at discharge, and 6 weeks discharge.)
Measured: Average of 100 days post-transplant
Change from Baseline Manual Muscle Testing at 6 weeks post discharge
Muscle strength
Measured: Average of 100 days post-transplant
WeeFIM
Change from Baseline Functionality at 6 weeks post discharge.
Measured: Average of 100 days post-transplant
Secondary outcomes (2)
PROMISE Measures
Change from Quality of Life measurements based off of physical, mental, and social categories at 6 weeks post discharge
Measured: Average of 100 days post transplant
Time Out of Bed
Log of average time out of bed for each patient.
Measured: through study completion, average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start1 Oct 2017
- Primary completion1 Aug 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arizona
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692478
- Sponsor's protocol ID
- 16-127
- Status last verified
- Apr 2024
- First submitted
- 2 Nov 2017
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD on request
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Intrahospital Exercise Program in Pediatric Hematopoietic Stem Cell Transplant-A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06692478
- Acronym / sponsor ID
- 16-127
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Phoenix Children's HospitalUniversity, hospital or other
- Collaborators
- University of Arizona
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 18 Nov 2024 (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 randomized control study examines the effect of an intrahospital exercise regimen on the physical deconditioning that occurs due to hematopoietic stem cell transplant in the pediatric population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise regimenThis structured exercise program will incorporate a specially designed, low intensity, resistance based exercise regime created by our physical therapist. In addition to standard of care, it consists of strengthening, endurance, stretching and relaxation exercises tailored according to age and their ability to perform activities throughout their hospitalization. This exercise program will be done three times a week for 30-45 mins supervised by the same physiotherapist throughout hospitalization and will be self-administered every weekend. A home exercise program printout with the appropriate resistance exercises will be provided to the family upon discharge, with instructions on how often to complete throughout the week. Discharged children will attend one supervised exercise session per week with the physiotherapist for six weeks. The family and patient will also be provided a weekly sheet to check off the days they completed strengthening and endurance exercises. |
| Standard of Care | No intervention | –The second arm of the study involves patients following standard of care during the HSCT period in the hospital with PT evaluation and management prescribed as needed by their transplant medical team including any additional PT interventions as a result of clinical indications. No additional intervention is incorporated in this group |
Who may qualify
- Ages
- 4 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients ages 4-21 years of age who present for hematopoietic stem cell transplant.
- Karnofsky (if ≥16 years) or Lansky (if <16 years) score >60 at enrollment and prior to each testing point
- Parental/guardian permission (informed consent) and child assent prior to transplant.
Key exclusion criteria (3 listed)
- Patients with any preexisting need for gait assistance such as crutches, wheelchair, braces, or walker
- Previous stem cell transplant in the last 6 months
- Patients with grade 3 or greater sensory/motor neuropathy
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 |
|---|---|---|
| Exercise regimenAge 4-6 years: Target lower extremity, core and upper extremity strengthening and activity tolerance. With supervision by the PT, the patient will walk in their room, and complete the following through play: squat, single leg stance, climb onto couch, half kneel to stand, quadruped and tall kneeling. Age 7-21 years: First component will be strengthening exercises completed in bed or on a mat while sitting or standing. Multiple levels of exercises will be available, so that the program can be tailored to each patient and to their ability to perform activities. The exercises included will focus on core, hip musculature, and upper extremity strengthening; including exercises in quadruped and prone positioning, as well as supine, sitting and standing. Thera-Band will be used to increase resistance as needed. The second component will be endurance. Since the patients will be confined to their room this will include ambulation within the room, recumbent or pedal exerciser and step ups. | Behavioural | Exercise |
Primary outcome
Change from Baseline 6-minute walk test at 6 weeks discharge.
Time frame: Average of 100 days post-transplant
Test of Endurance (Pre-transplant, at discharge, and 6 weeks discharge.)
Change from Baseline Manual Muscle Testing at 6 weeks post discharge
Time frame: Average of 100 days post-transplant
Muscle strength
WeeFIM
Time frame: Average of 100 days post-transplant
Change from Baseline Functionality at 6 weeks post discharge.
2 secondary outcomes
PROMISE Measures
Time frame: Average of 100 days post transplant
Time Out of Bed
Time frame: through study completion, average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: No. IPD on request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise regimen in people with Hematopoietic Stem Cell Transplant and Pediatric Cancer, run by Phoenix Children's Hospital at 1 site in United States.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 18 Nov 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline 6-minute walk test at 6 weeks discharge. (time frame: Average of 100 days post-transplant). The study lists 3 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 18 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.