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NCT Number: NCT07122479

Prevention of Hospital Acquired Deconditioning in Hospitalized Acute Leukemia Patients

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Shore University Hospital (NSUH), Manhasset, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Three-Pronged Approach to Reduce Hospital Acquired Deconditioning

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.

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 12 months

    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.

Other outcomes

  1. Adherence rates of daily physical exercise

    Time frame: 12 months

    To assess if there is a difference in adherence rates of daily physical exercise between age groups

  2. Number of days admitted prior to initiation of treatment

    Time frame: 12 months

    To assess if number of days admitted prior to initiation of treatment affects adherence rates to daily physical activity

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

    Time frame: 12 months

    To assess the impact of adherence to daily physical activity on re-admission rates for complications within 6 months of induction treatment

  4. Assess impact of adherence to daily physical activity on hospital admission cost

    Time frame: 12 months

    To assess impact of adherence to daily physical activity on hospital admission cost

  5. Assess if daily recording of physical activity improves monitoring

    Time frame: 12 months

    To assess if daily recording of physical activity improves monitoring of risk for HAD

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 14, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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