Prevention of Hospital Acquired Deconditioning in Hospitalized Acute Leukemia Patients

NCT ID: NCT07122479

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-27
• Study Completion Date: 2025-08-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Three-Prong Approach to Reduce Hospital Acquired Deconditioning

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.

Group Type: OTHER

Three-Pronged Approach to Reduce Hospital Acquired Deconditioning

Intervention Type: OTHER

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.

Interventions

Three-Pronged Approach to Reduce Hospital Acquired Deconditioning

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie Boisclair, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

North Shore University Hospital (NSUH)

Manhasset, New York, United States

Zuckerberg Cancer Center

New Hyde Park, New York, United States

Countries

United States

Other Identifiers

23-0527

Identifier Type: -

Identifier Source: org_study_id