Stem Cell Transplantation, HematopoieticNCT02577939
Evaluation of Cardiorespiratory Performance After Interval Exercise Training Prior to Hematopoietic Cell Transplantation
A study testing Interval Exercise Training (IET) in people with Stem Cell Transplantation, Hematopoietic, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The primary objective of this study is to demonstrate the efficacy of a pre-transplant, interval exercise training (IET) intervention, in increasing peak oxygen uptake (VO2peak) scores on cycle ergometry. This study will have a lead-in phase to ensure that IET is feasible in this population. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stem Cell Transplantation, Hematopoietic
- What is being tested?
- Interval Exercise Training (IET)
- 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
- Jun 2013to Jun 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Not currently participating in IET training
- Willing and able to provide signed, informed consent
- Planned autologous or allogeneic stem cell transplant with schedule that accommodates a 6 week exercise intervention
- Willing to participate in an IET program that will last 6 weeks.
- Subject must complete at least one interval exercise session during the 6 weeks in order to be eligible for analysis.
- Planning to undergo transplant but continuing to receive cycles of chemotherapy on a previously started regimen while awaiting transplant
Who cannot join
- Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent
- Received erythropoiesis-stimulating proteins (ESPs) within 4 weeks prior to enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
About this study
Official title: Evaluation of Cardiorespiratory Performance After Interval Exercise Training (IET) Prior to Hematopoietic Cell Transplantation
The primary objective of this study is to demonstrate the efficacy of a pre-transplant, interval exercise training (IET) intervention, in increasing peak oxygen uptake (VO2peak) scores on cycle ergometry. This study will have a lead-in phase to ensure that IET is feasible in this population. Secondary objectives include documenting the safety of IET in this population, evaluating the correlation of VO2peak with other methods of measuring pre-transplant cardiorespiratory performance, comparing the 6 minute walk distance (6MWD) pre and post IET, and establishing the feasibility of the 6MWD when performed unsupervised by a health care professional.
Eligible patients include 40 evaluable autologous (n=20) and allogeneic (n=20; 10 full intensity and 10 reduced intensity) transplant patients deemed appropriate for exercise intervention by their treating physician. The investigators will enroll no more than 50 patients onto this trial. Results of this study will inform a randomized, multi-site study of a pre-transplant exercise intervention.
Read the detailed description
The primary purpose of the study is to determine the ability of a pre-transplant exercise intervention to improve cardiorespiratory performance (measured by VO2peak). If the safety of this approach is documented, and its efficacy demonstrated, a foundation will be laid for a larger, randomized, multi-center study to formally determine the benefit of the pre-transplant exercise intervention.
We plan to analyze the effect of IET on VO2peak in the auto and allo groups separately given their different course of treatment and outcomes. Study subjects will be recruited after they and their transplant teams have decided that they will undergo HCT. Following recruitment, patients will undergo baseline fitness assessments and then receive an individualized IET prescription for a duration of 6 weeks prior to stem cell mobilization (auto) or prior to hospitalization for conditioning (allo). For the first two weeks, subjects will undergo three times weekly 3 minute interval training during walking at 60-70% MHR. This will be followed by three times weekly aerobic interval training for 5 three-minute bouts at 65-85% maximum heart rate per session for 4 weeks.
All patients will also be provided with a FitBit accelerometer. Prior to transplant, patients will undergo follow-up fitness assessments. All patients will undergo activity tracking by accelerometry (FitBit) and admission/weekly symptom/HRQOL tracking by electronic survey throughout the post-transplant hospitalization. Also during hospitalization, all patients will perform weekly clinician supervised 6MWD testing while inpatient. One of the weekly tests during hospitalization will include patient self-administered (clinician observed) 6MWD, along with the clinician supervised 6MWD. Unsupervised patient performed 6MWD will be considered feasible if all patients who perform 6MWD can do so safely, and if for 80% of patients, the patient-performed 6MWD values are within 10% of the corresponding clinician supervised 6MWD results. If feasibility is met, we will ask patients to perform the 6MWD weekly for 4 weeks post discharge and record their distance.
- Conditions
- Stem Cell Transplantation, Hematopoietic
- Being tested
- Interval Exercise Training (IET)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interval Exercise Training (IET)Behavioural
Also called Aerobic Training, Aerobic Exercise, Endurance Training
This is a single arm study. All patients receive the intervention of 6 weeks of pre-transplant IET, pre- and post-tests, and data collection via FitBit accelerometer and weekly surveys.
| Study group | Role | What they receive |
|---|---|---|
| Interval Exercise Training (IET) | Experimental | This is a single arm study. All patients receive the intervention of 6 weeks of pre-transplant IET, pre- and post-tests, and data collection via FitBit accelerometer and weekly surveys. Receives: Behavioral: Interval Exercise Training (IET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Of those patients with heart rate data, number and percent of patients able to achieve 65-85% heart rate during one or more exercise sessions. Unit of measurement: number of patients and percent of patients with evaluable heart rate data.
Establish the feasibility of IET in patients prior to autologous or allogeneic transplantation. Feasibility is defined as 5 of the first 10 evaluable patients being able to achieve 65-85% heart rate during one or more exercise sessions throughout the duration of the interval exercise training.
Measured: During the 6 weeks of IET pre-transplant
Secondary outcomes (3)
Number of adverse events as reported by patients and determined by study investigators. Unit of measurement: cumulative number of adverse events.
Documentations of any IET related complications during the 6 week training program
Measured: During the 6 weeks of IET pre-transplant
Change in 6 minute walk distance based on pre- and post- intervention 6 minute walk distance testing. Unit of measurement: meters.
Evaluate cardiorespiratory performance as measured via 6MWD pre and post IET
Measured: Pre- and Post- Assessment for 6 weeks of IET
Change in VO2peak based on pre- and post- intervention VO2peak measurement from cardiopulmonary exercise testing. Unit of measurement: ml/kg*min.
Evaluate cardiorespiratory performance as measured via VO2peak pre and post IET
Measured: Pre- and Post- Assessment for 6 weeks of IET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startJun 2013
- Primary completionMar 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell Transplantation, HematopoieticStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William A Wood, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577939
- Sponsor's protocol ID
- LCCC 1311
- Status last verified
- Oct 2015
- First submitted
- 20 Feb 2015
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiorespiratory Performance After Interval Exercise Training (IET) Prior to Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT02577939
- Acronym / sponsor ID
- LCCC 1311
- Conditions
- Stem Cell Transplantation, Hematopoietic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 Oct 2015 (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.
The primary objective of this study is to demonstrate the efficacy of a pre-transplant, interval exercise training (IET) intervention, in increasing peak oxygen uptake (VO2peak) scores on cycle ergometry. This study will have a lead-in phase to ensure that IET is feasible in this population. Secondary objectives include documenting the safety of IET in this population, evaluating the correlation of VO2peak with other methods of measuring pre-transplant cardiorespiratory performance, comparing the 6 minute walk distance (6MWD) pre and post IET, and establishing the feasibility of the 6MWD when performed unsupervised by a health care professional.
Eligible patients include 40 evaluable autologous (n=20) and allogeneic (n=20; 10 full intensity and 10 reduced intensity) transplant patients deemed appropriate for exercise intervention by their treating physician. The investigators will enroll no more than 50 patients onto this trial. Results of this study will inform a randomized, multi-site study of a pre-transplant exercise intervention.
Detailed description
The primary purpose of the study is to determine the ability of a pre-transplant exercise intervention to improve cardiorespiratory performance (measured by VO2peak). If the safety of this approach is documented, and its efficacy demonstrated, a foundation will be laid for a larger, randomized, multi-center study to formally determine the benefit of the pre-transplant exercise intervention.
We plan to analyze the effect of IET on VO2peak in the auto and allo groups separately given their different course of treatment and outcomes. Study subjects will be recruited after they and their transplant teams have decided that they will undergo HCT. Following recruitment, patients will undergo baseline fitness assessments and then receive an individualized IET prescription for a duration of 6 weeks prior to stem cell mobilization (auto) or prior to hospitalization for conditioning (allo). For the first two weeks, subjects will undergo three times weekly 3 minute interval training during walking at 60-70% MHR. This will be followed by three times weekly aerobic interval training for 5 three-minute bouts at 65-85% maximum heart rate per session for 4 weeks.
All patients will also be provided with a FitBit accelerometer. Prior to transplant, patients will undergo follow-up fitness assessments. All patients will undergo activity tracking by accelerometry (FitBit) and admission/weekly symptom/HRQOL tracking by electronic survey throughout the post-transplant hospitalization. Also during hospitalization, all patients will perform weekly clinician supervised 6MWD testing while inpatient. One of the weekly tests during hospitalization will include patient self-administered (clinician observed) 6MWD, along with the clinician supervised 6MWD. Unsupervised patient performed 6MWD will be considered feasible if all patients who perform 6MWD can do so safely, and if for 80% of patients, the patient-performed 6MWD values are within 10% of the corresponding clinician supervised 6MWD results. If feasibility is met, we will ask patients to perform the 6MWD weekly for 4 weeks post discharge and record their distance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interval Exercise Training (IET) | Experimental | Behavioral: Interval Exercise Training (IET)This is a single arm study. All patients receive the intervention of 6 weeks of pre-transplant IET, pre- and post-tests, and data collection via FitBit accelerometer and weekly surveys. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Not currently participating in IET training
- Willing and able to provide signed, informed consent
- Planned autologous or allogeneic stem cell transplant with schedule that accommodates a 6 week exercise intervention
- Willing to participate in an IET program that will last 6 weeks.
- Subject must complete at least one interval exercise session during the 6 weeks in order to be eligible for analysis.
Key exclusion criteria (2 listed)
- Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent
- Received erythropoiesis-stimulating proteins (ESPs) within 4 weeks prior to enrollment
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 |
|---|---|---|
| Interval Exercise Training (IET)Also: Aerobic Training, Aerobic Exercise, Endurance TrainingThis is a single arm study. All patients receive the intervention of 6 weeks of pre-transplant IET, pre- and post-tests, and data collection via FitBit accelerometer and weekly surveys. | Behavioural | Interval Exercise Training (IET) |
Primary outcome
Of those patients with heart rate data, number and percent of patients able to achieve 65-85% heart rate during one or more exercise sessions. Unit of measurement: number of patients and percent of patients with evaluable heart rate data.
Time frame: During the 6 weeks of IET pre-transplant
Establish the feasibility of IET in patients prior to autologous or allogeneic transplantation. Feasibility is defined as 5 of the first 10 evaluable patients being able to achieve 65-85% heart rate during one or more exercise sessions throughout the duration of the interval exercise training.
3 secondary outcomes
Number of adverse events as reported by patients and determined by study investigators. Unit of measurement: cumulative number of adverse events.
Time frame: During the 6 weeks of IET pre-transplant
Change in 6 minute walk distance based on pre- and post- intervention 6 minute walk distance testing. Unit of measurement: meters.
Time frame: Pre- and Post- Assessment for 6 weeks of IET
Change in VO2peak based on pre- and post- intervention VO2peak measurement from cardiopulmonary exercise testing. Unit of measurement: ml/kg*min.
Time frame: Pre- and Post- Assessment for 6 weeks of IET
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 16 Oct 2015.
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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.
William A Wood, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interval Exercise Training (IET) in people with Stem Cell Transplantation, Hematopoietic, run by UNC Lineberger Comprehensive Cancer Center 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 6 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: finished, as of the sponsor's last update on 16 Oct 2015. 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?
Of those patients with heart rate data, number and percent of patients able to achieve 65-85% heart rate during one or more exercise sessions. Unit of measurement: number of patients and percent of patients with evaluable heart rate data. (time frame: During the 6 weeks of IET pre-transplant). 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 16 Oct 2015.