Adult Acute Myeloid Leukemia in RemissionNCT01519596
Symptom-Adapted Physical Activity Intervention in Minimizing Physical Function Decline in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy
A study testing quality-of-life assessment, counseling intervention and exercise intervention in people with Adult Acute Myeloid Leukemia in Remission and Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This is a randomized clinical trial that studies symptom-adapted physical activity intervention in minimizing physical function decline in older patients with acute myeloid leukemia (AML) undergoing chemotherapy. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q)
- What is being tested?
- quality-of-life assessment, counseling intervention and exercise intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 5 Feb 2017
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of AML with pathologic confirmation by World Health Organization (WHO) criteria
- Planned induction chemotherapy
- Absence of active medical problems that preclude participation in exercise (including, but not limited to: bleeding, acute thrombosis, ischemia, hemodynamic instability, uncontrolled pain)
- Patient must be ambulatory or able to walk with a cane
- Patients must have limited cognitive deficits (< 3 incorrect responses on the Pfeiffer Mental Status Scale)
- Adequate English skills to understand and complete questionnaires
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Presence of active medical conditions precluding participation to exercise (e.g., ischemia, bleeding, thrombosis, uncontrolled pain, hemodynamic instability)
- Inability to ambulate
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Minimizing Physical Function Decline in Older Adults Receiving Chemotherapy
This is a randomized clinical trial that studies symptom-adapted physical activity intervention in minimizing physical function decline in older patients with acute myeloid leukemia (AML) undergoing chemotherapy. Physical activity may help decrease functional impairment and improve the quality of life in patients with AML undergoing chemotherapy.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the feasibility of conducting a symptom-adapted, randomized behavioral intervention designed to improve physical function in older adults receiving chemotherapy for AML.
II. To estimate the effect size of the physical activity intervention on change in an objective measure of physical function, SPPB (short physical performance battery).
SECONDARY OBJECTIVES:
- To estimate the effects of the physical activity intervention on self-reported physical function, health-related quality of life, and symptoms (depression, distress, fatigue).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients participate in an orientation session introducing the exercise program and protocol, reviewing fundamental principles, and demonstrating each activity. Patients also receive educational materials to facilitate orientation and adherence. Patients are offered 20-50 minute standard, intermediate, and/or low intensity physical activity sessions 5 days a week for 4 weeks. Patients also receive lifestyle-related counseling for 20-30 minutes once weekly.
ARM II: Patients undergo usual care for 4 weeks.
After completion of study treatment, patients are followed up every two weeks for two months and then monthly until week 24.
- Conditions
- Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
- Being tested
- quality-of-life assessment, counseling intervention, exercise intervention, educational intervention, standard follow-up care
- Medical subject headings
- Congenital Abnormalities, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
counseling interventionOther
Also called counseling and communications studies
Receive lifestyle-related counseling
exercise interventionBehavioural
Undergo physical activity intervention
educational interventionOther
Also called intervention, educational
Receive educational materials
standard follow-up careProcedure or surgery
Undergo usual care
| Study group | Role | What they receive |
|---|---|---|
| Arm I (physical activity) | Experimental | Patients participate in an orientation session introducing the exercise program and protocol, reviewing fundamental principles, and demonstrating each activity. Patients also receive educational materials to facilitate orientation and adherence. Patients are offered 20-50 minute standard, intermediate, and/or low intensity physical activity sessions 5 days a week for 4 weeks. Patients also receive lifestyle-related counseling for 20-30 minutes once weekly. Receives: Procedure: quality-of-life assessment; Other: counseling intervention; Behavioral: exercise intervention; Other: educational intervention |
| Arm II (usual care) | Active comparator | Patients undergo usual care for 4 weeks. Receives: Procedure: quality-of-life assessment; Procedure: standard follow-up care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, in terms of participation rates and barriers to recruitment and retention
Number of exercise sessions completed, dropout rates, completion rates of the physical function measures, and completion rates of questionnaires will be recorded. Adherence will be defined as completion of at least 60% of the offered sessions.
Measured: Approximately 4 weeks
Magnitude and trajectory of changes in objective physical function
Characterized using mixed model analysis of variance (ANOVA) with an appropriate error structure to account for the correlated nature of the data.
Measured: Approximately 4 weeks
Secondary outcomes (2)
Self-reported physical function using the SPPB, PAT-D, MAT-sf, grip strength, and lower extremity strength
Measured: Approximately 4 weeks
Self-reported quality of life
Measured: Approximately 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startOct 2012
- Primary completion5 Mar 2015
- Study completion5 Feb 2017
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 Adult Acute Myeloid Leukemia in RemissionStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Heidi Klepin, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519596
- Sponsor's protocol ID
- IRB00019467
- Other IDs
- NCI-2012-00003, CCCWFU 97711
- Status last verified
- Aug 2019
- First submitted
- 20 Jan 2012
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Klepin HD, Tooze JA, Rejeski WJ, Mihalko S, Pardee TS, Ellis L, Howard D, Demark-Wahnefried W, Powell BL, Kritchevsky S. Pilot study of an inpatient physical activity intervention for older adults treated intensively for acute myeloid leukemia. Blood Adv. 2025 Oct 28;9(20):5152-5163. doi: 10.1182/bloodadvances.2025016260.
PubMed 40737540
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimizing Physical Function Decline in Older Adults Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT01519596
- Acronym / sponsor ID
- IRB00019467
- Conditions
- Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2012
- Primary completion
- 5 Mar 2015 (actual)
- Study completion
- 5 Feb 2017 (actual)
- First posted
- 27 Jan 2012 (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.
This is a randomized clinical trial that studies symptom-adapted physical activity intervention in minimizing physical function decline in older patients with acute myeloid leukemia (AML) undergoing chemotherapy. Physical activity may help decrease functional impairment and improve the quality of life in patients with AML undergoing chemotherapy.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the feasibility of conducting a symptom-adapted, randomized behavioral intervention designed to improve physical function in older adults receiving chemotherapy for AML.
II. To estimate the effect size of the physical activity intervention on change in an objective measure of physical function, SPPB (short physical performance battery).
SECONDARY OBJECTIVES:
- To estimate the effects of the physical activity intervention on self-reported physical function, health-related quality of life, and symptoms (depression, distress, fatigue).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients participate in an orientation session introducing the exercise program and protocol, reviewing fundamental principles, and demonstrating each activity. Patients also receive educational materials to facilitate orientation and adherence. Patients are offered 20-50 minute standard, intermediate, and/or low intensity physical activity sessions 5 days a week for 4 weeks. Patients also receive lifestyle-related counseling for 20-30 minutes once weekly.
ARM II: Patients undergo usual care for 4 weeks.
After completion of study treatment, patients are followed up every two weeks for two months and then monthly until week 24.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (physical activity) | Experimental | Procedure: quality-of-life assessment, Other: counseling intervention, Behavioral: exercise intervention, Other: educational interventionPatients participate in an orientation session introducing the exercise program and protocol, reviewing fundamental principles, and demonstrating each activity. Patients also receive educational materials to facilitate orientation and adherence. Patients are offered 20-50 minute standard, intermediate, and/or low intensity physical activity sessions 5 days a week for 4 weeks. Patients also receive lifestyle-related counseling for 20-30 minutes once weekly. |
| Arm II (usual care) | Active comparator | Procedure: quality-of-life assessment, Procedure: standard follow-up carePatients undergo usual care for 4 weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of AML with pathologic confirmation by World Health Organization (WHO) criteria
- Planned induction chemotherapy
- Absence of active medical problems that preclude participation in exercise (including, but not limited to: bleeding, acute thrombosis, ischemia, hemodynamic instability, uncontrolled pain)
- Patient must be ambulatory or able to walk with a cane
- Patients must have limited cognitive deficits (< 3 incorrect responses on the Pfeiffer Mental Status Scale)
Key exclusion criteria (2 listed)
- Presence of active medical conditions precluding participation to exercise (e.g., ischemia, bleeding, thrombosis, uncontrolled pain, hemodynamic instability)
- Inability to ambulate
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 |
|---|---|---|
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm I (physical activity), Arm II (usual care) |
| counseling interventionAlso: counseling and communications studiesReceive lifestyle-related counseling | Other | Arm I (physical activity) |
| exercise interventionUndergo physical activity intervention | Behavioural | Arm I (physical activity) |
| educational interventionAlso: intervention, educationalReceive educational materials | Other | Arm I (physical activity) |
| standard follow-up careUndergo usual care | Procedure or surgery | Arm II (usual care) |
Primary outcome
Feasibility, in terms of participation rates and barriers to recruitment and retention
Time frame: Approximately 4 weeks
Number of exercise sessions completed, dropout rates, completion rates of the physical function measures, and completion rates of questionnaires will be recorded. Adherence will be defined as completion of at least 60% of the offered sessions.
Magnitude and trajectory of changes in objective physical function
Time frame: Approximately 4 weeks
Characterized using mixed model analysis of variance (ANOVA) with an appropriate error structure to account for the correlated nature of the data.
2 secondary outcomes
Self-reported physical function using the SPPB, PAT-D, MAT-sf, grip strength, and lower extremity strength
Time frame: Approximately 4 weeks
Self-reported quality of life
Time frame: Approximately 24 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 16 Aug 2019.
- Derived from this study: PubMed 40737540Klepin HD, Tooze JA, Rejeski WJ, Mihalko S, Pardee TS, Ellis L, Howard D, Demark-Wahnefried W, Powell BL, Kritchevsky S. Pilot study of an inpatient physical activity intervention for older adults treated intensively for acute myeloid leukemia. Blood Adv. 2025 Oct 28;9(20):5152-5163. doi: 10.1182/bloodadvances.2025016260.
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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.
Heidi Klepin principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quality-of-life assessment, counseling intervention and exercise intervention in people with Adult Acute Myeloid Leukemia in Remission and Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, run by Wake Forest University Health Sciences 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 7 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 Aug 2019. 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?
Feasibility, in terms of participation rates and barriers to recruitment and retention (time frame: Approximately 4 weeks). The study lists 2 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 NCT01519596, 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 16 Aug 2019.