ExerciseNCT04663503
Benefits of Exercise Program in Pediatric HSCT
A study testing Exercise program in people with Exercise and Transplantation, run by Phoenix Children's Hospital at 1 site in United States.
Trial summary
Deconditioning is a common adverse effect of short and long-term immobilization. For months pediatric hematopoietic stem cell transplant patients can be quarantined while hospitalized, much of which time is spent immobilized putting these patients at a higher risk for loss of muscle strength, functionality, endurance… Read more about this study
- Who is it for?
- Ages 4 to 21 years
- Conditions the study is for
- Exercise, Transplantation
- What is being tested?
- Exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2019to 12 Apr 2021
- 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
- Subjects age 4-21 years
- Admitted for Hematopoietic Stem Cell 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
Deconditioning is a common adverse effect of short and long-term immobilization. For months pediatric hematopoietic stem cell transplant patients can be quarantined while hospitalized, much of which time is spent immobilized putting these patients at a higher risk for loss of muscle strength, functionality, endurance, and quality of life. Phoenix Children's Hospital is conducting approximately forty (40) transplants per year. Adult studies have shown that exercise as an effective counter measure to deconditioning in stem cell transplant patients. However, there is a knowledge gap in pediatric HSCT. Thus this study is being conducted to determine if there is a correlation between intra-hospital exercise and improved functionality, mobility, strength, and quality of life. To achieve these aims investigators will perform a randomized control study. The investigators will aim to recruit 40 patients, 20 in each arm, ages 4-21 at Phoenix Children's Hospital. Each participant will receive baseline measures by a physical therapist; for functionality using (WeeFIM), muscle strength using manual muscle testing (MMT), endurance using the 6-minute walk test, and quality of life using the NIH PROMIS measures. Measurements will be taken again at discharge and 6-weeks post-discharge. During hospital admittance the intervention group will perform exercise routines 3 times weekly while the control group will be treated per standard of care with no exercise intervention. Patients recruited must be receiving first HSCT. A full explanation of the study and possible benefits will be given to the patients and their families upon consent. Primary outcomes will look at endurance, functionality and muscle strength. Secondary outcomes will include QoL and amount of achievable "time out of bed".
Read the detailed description
Despite growing numbers of publications describing the effects of these exercise modalities in adult HSCT patients, only limited attention has been paid to this effective supportive therapy in children. Only five publications describe the effectiveness of exercise training in pediatric HSCT. San Juan et al. showed beneficial effects on functional performance, muscle strength, and Qol scores in a study of children (aged 8-16) undergoing a supervised exercise program that included resistance and aerobic exercises for 3 weeks after HSCT. In another study, the moderate intensity exercise program implemented to children undergoing allogeneic HSCT for 3 weeks during hospitalization showed positive effects on body mass and body mass index (BMI), and no negative effect on immune cell recovery. It was found that a structured physical activity program has positive effects on Qol and fatigue scores in children undergoing peripheral blood stem cell transplantation. Yildez et al. showed improvement in areas such as functional performance, muscle strength, functional mobility. Marchese et al. showed an improvement in knee extension strength and ankle dorsiflexion range of motion.This study will implement an exercise program that is personalized to hematopoietic stem cell transplant recipients designed to prevent a decline in function/independence. Investigators will accomplish this by conducting a randomized controlled trial (RCT) that will examine the effect of an 8-12 week personalized exercise program compared to standard care following hematopoietic stem cell transplantation. Data from this study should increase understanding of the effect of exercise in this population on QoL, functional ability, endurance, muscle strength, and fatigue.
- Conditions
- Exercise, Transplantation
- Being tested
- Exercise program
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programOther
Depending on the age, there will be two components of the exercise program completed by the patients. The first component will be strengthening exercises. The second component will be endurance activities. This will be administered by the physical therapist
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm -Exercise Program | Experimental | This structured exercise program will incorporate a specially designed, low intensity, resistance based exercise regime created by our physical therapist. It consists of strengthening, endurance, stretching and relaxation exercises tailored according to age and their ability to perform activities throughout their hospitalization (Appendix 3). 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: Other: Exercise program |
| Control arm- No intervention | 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.
Six minute walk test
Used in measuring exercise capacity and endurance.
Measured: Change from baseline at enrollment, to discharge from hospital and at 6 weeks post discharge
Pediatric Functional Independence Measure (WeeFIM)
Used to measure functionality.
Measured: Change from baseline at enrollment, to discharge from hospital and at 6 weeks post discharge. This would be done through study completion, an average of 12 weeks.
Manual muscle testing (MMT)
Useful to measure muscle strength
Measured: Change from baseline at enrollment, to discharge from hospital and at 6 weeks post discharge.This would be done through study completion, an average of 12 weeks.
Secondary outcomes (1)
Patient Reported Outcomes Measurement Information System (PROMIS) Measures
Changes in quality of life
Measured: Change from baseline at enrollment, to discharge from hospital and at 6 weeks post discharge. This would be done through study completion, an average of 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start11 Mar 2019
- Primary completion12 Apr 2021
- Study completion12 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Ngwube, Phoenix Children's Hospital
- Investigators
- Alexander Ngwube, MD, Principal investigator, Phoenix Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663503
- Sponsor's protocol ID
- IRB-16-127
- Status last verified
- Jan 2022
- First submitted
- 26 Aug 2020
- Last updated
- 1 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith C, Farhat R, Fern-Buneo A, Purrington H, Cobb E, Matson L, Kang P, Beebe K, Campbell C, Schwalbach C, Salzberg D, Miller H, Adams R, Ngwube A. Effects of an exercise program during pediatric stem cell transplantation: A randomized controlled trial. Pediatr Blood Cancer. 2022 May;69(5):e29618. doi: 10.1002/pbc.29618. Epub 2022 Feb 23.
PubMed 35195344
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. 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
- NCT04663503
- Acronym / sponsor ID
- IRB-16-127
- Conditions
- Exercise, Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Phoenix Children's HospitalUniversity, hospital or other
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 11 Dec 2020 (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.
Deconditioning is a common adverse effect of short and long-term immobilization. For months pediatric hematopoietic stem cell transplant patients can be quarantined while hospitalized, much of which time is spent immobilized putting these patients at a higher risk for loss of muscle strength, functionality, endurance, and quality of life. Phoenix Children's Hospital is conducting approximately forty (40) transplants per year. Adult studies have shown that exercise as an effective counter measure to deconditioning in stem cell transplant patients. However, there is a knowledge gap in pediatric HSCT. Thus this study is being conducted to determine if there is a correlation between intra-hospital exercise and improved functionality, mobility, strength, and quality of life. To achieve these aims investigators will perform a randomized control study. The investigators will aim to recruit 40 patients, 20 in each arm, ages 4-21 at Phoenix Children's Hospital. Each participant will receive baseline measures by a physical therapist; for functionality using (WeeFIM), muscle strength using manual muscle testing (MMT), endurance using the 6-minute walk test, and quality of life using the NIH PROMIS measures. Measurements will be taken again at discharge and 6-weeks post-discharge. During hospital admittance the intervention group will perform exercise routines 3 times weekly while the control group will be treated per standard of care with no exercise intervention. Patients recruited must be receiving first HSCT. A full explanation of the study and possible benefits will be given to the patients and their families upon consent. Primary outcomes will look at endurance, functionality and muscle strength. Secondary outcomes will include QoL and amount of achievable "time out of bed".
Detailed description
Despite growing numbers of publications describing the effects of these exercise modalities in adult HSCT patients, only limited attention has been paid to this effective supportive therapy in children. Only five publications describe the effectiveness of exercise training in pediatric HSCT. San Juan et al. showed beneficial effects on functional performance, muscle strength, and Qol scores in a study of children (aged 8-16) undergoing a supervised exercise program that included resistance and aerobic exercises for 3 weeks after HSCT. In another study, the moderate intensity exercise program implemented to children undergoing allogeneic HSCT for 3 weeks during hospitalization showed positive effects on body mass and body mass index (BMI), and no negative effect on immune cell recovery. It was found that a structured physical activity program has positive effects on Qol and fatigue scores in children undergoing peripheral blood stem cell transplantation. Yildez et al. showed improvement in areas such as functional performance, muscle strength, functional mobility. Marchese et al. showed an improvement in knee extension strength and ankle dorsiflexion range of motion.This study will implement an exercise program that is personalized to hematopoietic stem cell transplant recipients designed to prevent a decline in function/independence. Investigators will accomplish this by conducting a randomized controlled trial (RCT) that will examine the effect of an 8-12 week personalized exercise program compared to standard care following hematopoietic stem cell transplantation. Data from this study should increase understanding of the effect of exercise in this population on QoL, functional ability, endurance, muscle strength, and fatigue.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm -Exercise Program | Experimental | Other: Exercise programThis structured exercise program will incorporate a specially designed, low intensity, resistance based exercise regime created by our physical therapist. It consists of strengthening, endurance, stretching and relaxation exercises tailored according to age and their ability to perform activities throughout their hospitalization (Appendix 3). 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. |
| Control arm- No intervention | 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 (2 listed)
- Subjects age 4-21 years
- Admitted for Hematopoietic Stem Cell 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 programDepending on the age, there will be two components of the exercise program completed by the patients. The first component will be strengthening exercises. The second component will be endurance activities. This will be administered by the physical therapist | Other | Intervention arm -Exercise Program |
Primary outcome
Six minute walk test
Time frame: Change from baseline at enrollment, to discharge from hospital and at 6 weeks post discharge
Used in measuring exercise capacity and endurance.
Pediatric Functional Independence Measure (WeeFIM)
Time frame: Change from baseline at enrollment, to discharge from hospital and at 6 weeks post discharge. This would be done through study completion, an average of 12 weeks.
Used to measure functionality.
Manual muscle testing (MMT)
Time frame: Change from baseline at enrollment, to discharge from hospital and at 6 weeks post discharge.This would be done through study completion, an average of 12 weeks.
Useful to measure muscle strength
1 secondary outcome
Patient Reported Outcomes Measurement Information System (PROMIS) Measures
Time frame: Change from baseline at enrollment, to discharge from hospital and at 6 weeks post discharge. This would be done through study completion, an average of 12 weeks.
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 1 Feb 2022.
- Derived from this study: PubMed 35195344Smith C, Farhat R, Fern-Buneo A, Purrington H, Cobb E, Matson L, Kang P, Beebe K, Campbell C, Schwalbach C, Salzberg D, Miller H, Adams R, Ngwube A. Effects of an exercise program during pediatric stem cell transplantation: A randomized controlled trial. Pediatr Blood Cancer. 2022 May;69(5):e29618. doi: 10.1002/pbc.29618. Epub 2022 Feb 23.
- Individual participant dataSharing planned: No
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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.
Alexander Ngwube, MD principal investigator
Phoenix Children's 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 Exercise program in people with Exercise and Transplantation, 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 2 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 1 Feb 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 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?
Six minute walk test (time frame: Change from baseline at enrollment, to discharge from hospital and at 6 weeks post discharge). 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?
On the ClinicalTrials.gov record for NCT04663503, which also lists 1 linked publication.
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 1 Feb 2022.