Malignant NeoplasmNCT03672981
Resistance Training Program and Cardiovascular Exercise in Increasing Muscle Mass in Adolescent and Young Adult Stem Cell Transplant Survivors
A study testing Exercise Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Malignant Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This pilot trial studies how well a resistance training program and cardiovascular exercise work in increasing muscle mass in adolescent and young adult stem cell transplant survivors. Read more about this study
- Who is it for?
- Ages 13 to 39 years
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Exercise Intervention, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2018to 31 Oct 2020
- 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 13 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- > 80 days but less than <120 days post-autologous or allogeneic HCT for a malignancy.
- Platelet transfusion independent.
- Fully mobile on an independent basis.
- For patients who have been on steroid therapy for graft versus (vs) host disease, doses of prednisone must be =< 1.0 mg/kg/day and they must be on a tapering schedule.
- English speaking.
Who cannot join
- Individuals who are determined by the investigators or primary treating physician to not be physically able to participate in an independent exercise intervention such as hospitalized, wheel chair bound, unable to ambulate independently, on oxygen.
- Women who are pregnant will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Pilot Study of a Resistance Training Intervention in Adolescent and Young Adult Hematopoietic Cell Transplant Survivors
This pilot trial studies how well a resistance training program and cardiovascular exercise work in increasing muscle mass in adolescent and young adult stem cell transplant survivors. Resistance training and cardiovascular exercise may increase physical activity, muscular strength and improve lean body mass which is beneficial to improving the overall health of stem cell transplant survivors.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the feasibility of a 12-week resistance training (RT) intervention in adolescent and young adult (AYA) hematopoietic cell transplant (HCT) survivors starting +100 days post-HCT.
SECONDARY OBJECTIVES:
- Examine the change from baseline of a RT intervention on muscle strength and body composition at day +200 and day +365.
II. Determine the effectiveness of RT exercise on improving the cardio-metabolic risk factor profile at day +200 and day +365.
III. Determine the effectiveness of RT exercise on improving quality of life (QOL) measures.
IV. Compare day +80 and day +365 assessments to subjects in a historical control population.
OUTLINE:
Patients undergo moderately intense aerobic/cardiovascular exercise over 30-60 minutes and complete 1-2 sets of 8 to 10 resistance/strength training exercises, 8 to 12 repetitions of each exercise, 3 days per week for 12 weeks. Patients also participate in weekly phone calls with an exercise physiologist to ensure adherence to the program and to provide support.
After completion of study intervention, patients are followed up within 2 weeks, then at 365 days post HCT.
- Conditions
- Malignant Neoplasm
- Being tested
- Exercise Intervention, Quality-of-Life Assessment, Questionnaire Administration, Telephone-Based Intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
Undergo resistance training program and cardiovascular exercise
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Telephone-Based InterventionBehavioural
Participate in phone calls with exercise physiologist
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (aerobic exercise and resistance training) | Experimental | Patients undergo moderately intense aerobic/cardiovascular exercise over 30-60 minutes and complete 1-2 sets of 8 to 10 resistance/strength training exercises, 8 to 12 repetitions of each exercise, 3 days per week for 12 weeks. Patients also participate in weekly phone calls with an exercise physiologist to ensure adherence to the program and to provide support. Receives: Behavioral: Exercise Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
Percentage of eligible, approached patients enrolling in program
Measured: 200 Days
Completion rate
Percentage of enrolled participants completing the full intervention
Measured: At day +200 post hematopoietic cell transplant (HCT)
Adherence rate
Percentage of participants completing weekly follow-up phone calls
Measured: At day +200 post hematopoietic cell transplant (HCT)
Secondary outcomes (10)
Change in physical activity
Measured using Actigraph activity monitor
Measured: Baseline to day +365 post HCT
Change in physical activity
International Physical Activity Questionnaire (IPAQ)
Measured: Baseline to day +365 post HCT
Change in anthropometrics (BMI)
Measured by BMI; weight and height will be combined to report BMI in kg/m^2
Measured: Baseline to day +365 post HCT
Change in cardiometabolic profile (Fasting Glucose, Insulin and Lipid Profile)
Testing will be performed on patient blood samples. Changes will be calculated as score (approximately day +200) - score (approximately day+100). All variables will be described based on their distributions (means, standard deviations if normally distributed, medians and IQRs otherwise). A t-test will be used to compare means between baseline and follow-up time periods.
Measured: Baseline to day +365 post HCT
Heart rate
Measured: Baseline to day +365 post HCT
Change in body composition
Measured using dual-energy x-ray absorptiometry (DXA). Changes will be calculated as score (approximately day +200) - score (approximately day+100). All variables will be described based on their distributions (means, standard deviations if normally distributed, medians and IQRs otherwise). A t-test will be used to compare means between baseline and follow-up time periods.
Measured: Baseline to day +365 post HCT
Change in muscular strength
Strength testing will include hand grip strength, one repetition maximum chest press, one repetition maximum leg press and the 6 minute walk test. Changes will be calculated as score (approximately day +200) - score (approximately day +100). All variables will be described based on their distributions (means, standard deviations if normally distributed, medians and IQRs otherwise). A t-test will be used to compare means between baseline and follow-up time periods.
Measured: Baseline to day +365 post HCT
Blood pressure
Measured: Baseline to day +365 post HCT
Change in quality of life (QOL)
Measured by the Patient-Reported Outcomes Measurement Information System
Measured: Baseline to day +365 post HCT
Incidence of adverse events
Measured: Up to day +200 post HCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start21 Nov 2018
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Conquer Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Tyler Ketterl, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672981
- Sponsor's protocol ID
- 10046
- Other IDs
- NCI-2018-01254, 10046, P30CA015704, RG1001740
- Status last verified
- Nov 2020
- First submitted
- 19 Jul 2018
- Last updated
- 16 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Resistance Training Intervention in Adolescent and Young Adult Hematopoietic Cell Transplant Survivors
- ClinicalTrials.gov ID
- NCT03672981
- Acronym / sponsor ID
- 10046
- Conditions
- Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Conquer Cancer Foundation
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 17 Sep 2018 (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 pilot trial studies how well a resistance training program and cardiovascular exercise work in increasing muscle mass in adolescent and young adult stem cell transplant survivors. Resistance training and cardiovascular exercise may increase physical activity, muscular strength and improve lean body mass which is beneficial to improving the overall health of stem cell transplant survivors.
Detailed description
PRIMARY OBJECTIVES:
- Determine the feasibility of a 12-week resistance training (RT) intervention in adolescent and young adult (AYA) hematopoietic cell transplant (HCT) survivors starting +100 days post-HCT.
SECONDARY OBJECTIVES:
- Examine the change from baseline of a RT intervention on muscle strength and body composition at day +200 and day +365.
II. Determine the effectiveness of RT exercise on improving the cardio-metabolic risk factor profile at day +200 and day +365.
III. Determine the effectiveness of RT exercise on improving quality of life (QOL) measures.
IV. Compare day +80 and day +365 assessments to subjects in a historical control population.
OUTLINE:
Patients undergo moderately intense aerobic/cardiovascular exercise over 30-60 minutes and complete 1-2 sets of 8 to 10 resistance/strength training exercises, 8 to 12 repetitions of each exercise, 3 days per week for 12 weeks. Patients also participate in weekly phone calls with an exercise physiologist to ensure adherence to the program and to provide support.
After completion of study intervention, patients are followed up within 2 weeks, then at 365 days post HCT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (aerobic exercise and resistance training) | Experimental | Behavioral: Exercise Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Behavioral: Telephone-Based InterventionPatients undergo moderately intense aerobic/cardiovascular exercise over 30-60 minutes and complete 1-2 sets of 8 to 10 resistance/strength training exercises, 8 to 12 repetitions of each exercise, 3 days per week for 12 weeks. Patients also participate in weekly phone calls with an exercise physiologist to ensure adherence to the program and to provide support. |
Who may qualify
- Ages
- 13 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- > 80 days but less than <120 days post-autologous or allogeneic HCT for a malignancy.
- Platelet transfusion independent.
- Fully mobile on an independent basis.
- For patients who have been on steroid therapy for graft versus (vs) host disease, doses of prednisone must be =< 1.0 mg/kg/day and they must be on a tapering schedule.
- English speaking.
Key exclusion criteria (2 listed)
- Individuals who are determined by the investigators or primary treating physician to not be physically able to participate in an independent exercise intervention such as hospitalized, wheel chair bound, unable to ambulate independently, on oxygen.
- Women who are pregnant will be excluded.
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 InterventionUndergo resistance training program and cardiovascular exercise | Behavioural | Supportive Care (aerobic exercise and resistance training) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive Care (aerobic exercise and resistance training) |
| Questionnaire AdministrationAncillary studies | Other | Supportive Care (aerobic exercise and resistance training) |
| Telephone-Based InterventionParticipate in phone calls with exercise physiologist | Behavioural | Supportive Care (aerobic exercise and resistance training) |
Primary outcome
Enrollment rate
Time frame: 200 Days
Percentage of eligible, approached patients enrolling in program
Completion rate
Time frame: At day +200 post hematopoietic cell transplant (HCT)
Percentage of enrolled participants completing the full intervention
Adherence rate
Time frame: At day +200 post hematopoietic cell transplant (HCT)
Percentage of participants completing weekly follow-up phone calls
10 secondary outcomes
Change in physical activity
Time frame: Baseline to day +365 post HCT
Change in physical activity
Time frame: Baseline to day +365 post HCT
Change in anthropometrics (BMI)
Time frame: Baseline to day +365 post HCT
Change in cardiometabolic profile (Fasting Glucose, Insulin and Lipid Profile)
Time frame: Baseline to day +365 post HCT
Heart rate
Time frame: Baseline to day +365 post HCT
Change in body composition
Time frame: Baseline to day +365 post HCT
Change in muscular strength
Time frame: Baseline to day +365 post HCT
Blood pressure
Time frame: Baseline to day +365 post HCT
Change in quality of life (QOL)
Time frame: Baseline to day +365 post HCT
Incidence of adverse events
Time frame: Up to day +200 post HCT
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 Nov 2020.
- 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.
Tyler Ketterl principal investigator
Fred Hutch/University of Washington Cancer Consortium
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 Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Malignant Neoplasm, run by Fred Hutchinson 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 5 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 Nov 2020. 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?
Enrollment rate (time frame: 200 Days). 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 16 Nov 2020.