Acute LeukemiaNCT07122479
Prevention of Hospital Acquired Deconditioning in Hospitalized Acute Leukemia Patients
A study testing Three-Pronged Approach to Reduce Hospital Acquired Deconditioning in people with Acute Leukemia, run by Northwell Health at 2 sites in United States.
Trial summary
This study aims to decrease the incidence of hospital acquired deconditioning (HAD) and to help standardize daily physical exercise monitoring in acute leukemia patients with anticipated prolonged duration of hospital stay. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Leukemia
- What is being tested?
- Three-Pronged Approach to Reduce Hospital Acquired Deconditioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Oct 2023to 17 Jul 2026
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-99
- Patient admitted to North Shore University Hospital on 7Monti floor
- Diagnosis of acute leukemia (AML or ALL)
- Admitted for treatment with remission inducing therapy either in frontline, relapsed or salvage setting with anticipated hospital length of stay of at least 10 days
- ECOG 0-3 on day of induction.
Who cannot join
- Patients admitted for >14 days prior to initiation of treatment.
- Baseline altered mental status defined by Glasgow coma scale with score less than 15, that does not resolve within first 7 days of treatment as this would preclude participation in physical activity program.
- Baseline disability that would prevent participation in physical activity program.
- CML in acute blast phase.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
North Shore University Hospital (NSUH)
Manhasset, New York, 11030
Zuckerberg Cancer Center
New Hyde Park, New York, 11042
About this study
This study aims to decrease the incidence of hospital acquired deconditioning (HAD) and to help standardize daily physical exercise monitoring in acute leukemia patients with anticipated prolonged duration of hospital stay. The investigators hypothesize that implementing a patient-reported adherence log of their recommended standard daily set of exercises will help reduce proportion of hospital acquired deconditioning in acute leukemia patients. The investigators also hypothesize that less adherent patients will have more inpatient hospital related events and decreased health related quality of life.
Read the detailed description
Hospital-associated deconditioning (HAD), or post-hospital syndrome, describes the physical, cognitive, and functional decline that develops during hospitalization. Acute leukemia patients require inpatient chemotherapy treatments that often impose a minimal hospital stay of 21 days. While physical activity is recommended, its prescription and monitoring are not standardized, often leading to deconditioning developing before physical activity is urged.
This study aims to decrease the incidence of hospital acquired deconditioning (HAD) and to help standardize daily physical exercise monitoring in acute leukemia patients with anticipated prolonged duration of hospital stay. The investigators hypothesize that implementing a patient-reported adherence log of their recommended standard daily set of exercises will help reduce proportion of hospital acquired deconditioning in acute leukemia patients. The investigators also hypothesize that less adherent patients will have more inpatient hospital related events and decreased health related quality of life.
The intervention is a three-prong approach to reduce hospital acquired deconditioning in patients with anticipated prolonged length of stay for acute leukemia chemotherapy at North Shore University Hospital. The intervention includes 1) providing a set of daily physical exercises to patient according to their baseline performance status as assessed by physical therapist, 2) maintaining a patient-completed daily log of physical exercise adherence and 3) standardize the monitoring of physical exercise by the healthcare team by its inclusion in daily progress notes.
The results will assess the effectiveness of this intervention in reducing the occurrence proportion of HAD in the intervention group compared to historical controls. Additionally, the investigators will assess the correlation between patient reported adherence rate to the occurrence of hospital related events as well as its impact on health-related quality of life.
- Conditions
- Acute Leukemia
- Being tested
- Three-Pronged Approach to Reduce Hospital Acquired Deconditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-Pronged Approach to Reduce Hospital Acquired DeconditioningOther
The intervention includes 1) providing and demonstrating a set of daily physical exercises to patient according to their baseline performance status as assessed by physical therapist, 2) maintaining a patient-completed daily log of physical exercise adherence and 3) standardize the monitoring of physical exercise by the healthcare team by its inclusion in daily progress notes.
| Study group | Role | What they receive |
|---|---|---|
| Three-Prong Approach to Reduce Hospital Acquired Deconditioning | Other | The intervention is a three-prong approach to reduce hospital acquired deconditioning in patients with anticipated prolonged length of stay for acute leukemia chemotherapy. The intervention includes 1) providing and demonstrating a set of daily physical exercises to patient according to their baseline performance status as assessed by physical therapist, 2) maintaining a patient-completed daily log of physical exercise adherence and 3) standardize the monitoring of physical exercise by the healthcare team by its inclusion in daily progress notes. Receives: Other: Three-Pronged Approach to Reduce Hospital Acquired Deconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess Effectiveness of Prescribed Physical Exercise Program
daily log of physical exercise adherence and 3) standardize the monitoring of physical exercise by the healthcare team by its inclusion in daily progress notes.
Measured: 12 months
Secondary outcomes (1)
assess the correlation between patient-reported adherence rate (%) of daily physical exercise
to assess the correlation between patient-reported adherence rate (%) of daily physical exercise to occurrence of hospital related events and impact on health-related quality of life.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start27 Oct 2023
- Primary completion10 May 2024
- Study completion17 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Boisclair, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122479
- Sponsor's protocol ID
- 23-0527
- Status last verified
- Oct 2026
- First submitted
- 7 Aug 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Hospital Acquired Deconditioning in Hospitalized Acute Leukemia Patients
- ClinicalTrials.gov ID
- NCT07122479
- Acronym / sponsor ID
- 23-0527
- Conditions
- Acute Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 17 Jul 2026 (actual)
- First posted
- 14 Aug 2025 (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 study aims to decrease the incidence of hospital acquired deconditioning (HAD) and to help standardize daily physical exercise monitoring in acute leukemia patients with anticipated prolonged duration of hospital stay. The investigators hypothesize that implementing a patient-reported adherence log of their recommended standard daily set of exercises will help reduce proportion of hospital acquired deconditioning in acute leukemia patients. The investigators also hypothesize that less adherent patients will have more inpatient hospital related events and decreased health related quality of life.
Detailed description
Hospital-associated deconditioning (HAD), or post-hospital syndrome, describes the physical, cognitive, and functional decline that develops during hospitalization. Acute leukemia patients require inpatient chemotherapy treatments that often impose a minimal hospital stay of 21 days. While physical activity is recommended, its prescription and monitoring are not standardized, often leading to deconditioning developing before physical activity is urged.
This study aims to decrease the incidence of hospital acquired deconditioning (HAD) and to help standardize daily physical exercise monitoring in acute leukemia patients with anticipated prolonged duration of hospital stay. The investigators hypothesize that implementing a patient-reported adherence log of their recommended standard daily set of exercises will help reduce proportion of hospital acquired deconditioning in acute leukemia patients. The investigators also hypothesize that less adherent patients will have more inpatient hospital related events and decreased health related quality of life.
The intervention is a three-prong approach to reduce hospital acquired deconditioning in patients with anticipated prolonged length of stay for acute leukemia chemotherapy at North Shore University Hospital. The intervention includes 1) providing a set of daily physical exercises to patient according to their baseline performance status as assessed by physical therapist, 2) maintaining a patient-completed daily log of physical exercise adherence and 3) standardize the monitoring of physical exercise by the healthcare team by its inclusion in daily progress notes.
The results will assess the effectiveness of this intervention in reducing the occurrence proportion of HAD in the intervention group compared to historical controls. Additionally, the investigators will assess the correlation between patient reported adherence rate to the occurrence of hospital related events as well as its impact on health-related quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Three-Prong Approach to Reduce Hospital Acquired Deconditioning | Other | Other: Three-Pronged Approach to Reduce Hospital Acquired DeconditioningThe intervention is a three-prong approach to reduce hospital acquired deconditioning in patients with anticipated prolonged length of stay for acute leukemia chemotherapy. The intervention includes 1) providing and demonstrating a set of daily physical exercises to patient according to their baseline performance status as assessed by physical therapist, 2) maintaining a patient-completed daily log of physical exercise adherence and 3) standardize the monitoring of physical exercise by the healthcare team by its inclusion in daily progress notes. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-99
- Patient admitted to North Shore University Hospital on 7Monti floor
- Diagnosis of acute leukemia (AML or ALL)
- Admitted for treatment with remission inducing therapy either in frontline, relapsed or salvage setting with anticipated hospital length of stay of at least 10 days
- ECOG 0-3 on day of induction.
Key exclusion criteria (4 listed)
- Patients admitted for >14 days prior to initiation of treatment.
- Baseline altered mental status defined by Glasgow coma scale with score less than 15, that does not resolve within first 7 days of treatment as this would preclude participation in physical activity program.
- Baseline disability that would prevent participation in physical activity program.
- CML in acute blast phase.
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 |
|---|---|---|
| Three-Pronged Approach to Reduce Hospital Acquired DeconditioningThe intervention includes 1) providing and demonstrating a set of daily physical exercises to patient according to their baseline performance status as assessed by physical therapist, 2) maintaining a patient-completed daily log of physical exercise adherence and 3) standardize the monitoring of physical exercise by the healthcare team by its inclusion in daily progress notes. | Other | Three-Prong Approach to Reduce Hospital Acquired Deconditioning |
Primary outcome
Assess Effectiveness of Prescribed Physical Exercise Program
Time frame: 12 months
daily log of physical exercise adherence and 3) standardize the monitoring of physical exercise by the healthcare team by its inclusion in daily progress notes.
1 secondary outcome
assess the correlation between patient-reported adherence rate (%) of daily physical exercise
Time frame: 12 months
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 8 Oct 2026.
- 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.
Stephanie Boisclair, MD principal investigator
Northwell Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three-Pronged Approach to Reduce Hospital Acquired Deconditioning in people with Acute Leukemia, run by Northwell Health at 2 sites 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 4 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 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Assess Effectiveness of Prescribed Physical Exercise Program (time frame: 12 months). 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 8 Oct 2026.