NCT07122479

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 14, 2025

Completed
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

August 7, 2025

Last Update Submit

August 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (1)

  • assess the correlation between patient-reported adherence rate (%) of daily physical exercise

    12 months

Other Outcomes (5)

  • Adherence rates of daily physical exercise

    12 months

  • Number of days admitted prior to initiation of treatment

    12 months

  • Impact of adherence to daily physical activity on re-admission rates

    12 months

  • +2 more other outcomes

Study Arms (1)

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.

Other: Three-Pronged Approach to Reduce Hospital Acquired Deconditioning

Interventions

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.

Three-Prong Approach to Reduce Hospital Acquired Deconditioning

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

North Shore University Hospital (NSUH)

Manhasset, New York, 11030, United States

Location

Zuckerberg Cancer Center

New Hyde Park, New York, 11042, United States

Location

Study Officials

  • Stephanie Boisclair, MD

    Northwell Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2025

First Posted

August 14, 2025

Study Start

October 27, 2023

Primary Completion

May 10, 2024

Study Completion

August 1, 2025

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations