Exercise Prehab in Older Adults With Hematologic Malignancies

Maintaining Fitness: Exercise in Patients With Hematologic Malignancy

This pilot trial studies a structured exercise program intervention in improving physical activity in older patients with hematologic malignancies undergoing cancer therapy. Patients with hematologic malignancies are at an increased risk of functional dependence and injury. Structured exercise programs, such as the Otago exercise programme (OEP), may improve balance, strength, and prevent fall-related injury in older patients with hematologic malignancies undergoing cancer therapy.

Study Overview

• Status: Completed
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Behavioral: Exercise Intervention; Procedure: Physical Therapy

Detailed Description

PRIMARY OBJECTIVES:

I. To assess the feasibility of implementing a structured exercise program by evaluating recruitment and retention, exercise program adherence, sustainability, adverse events, and implementation challenge.

SECONDARY OBJECTIVES:

I. To calculate preliminary effect sizes of the impact of an exercise program in patients with hematologic malignancy undergoing therapy, as measured by:

• Cancer and Aging Research Group (CARG) Geriatric Assessment Tool parameters.
• Change in Short Physical Performance Battery (SPPB).
• Number and severity of falls.
• Impact of motivation and self-efficacy on adherence.
• Hospital readmission rates (if applicable).
• Length of inpatient stays (if applicable).
• Patient Reported Outcome Measurement Information System (PROMIS) for Health related quality of life (HRQL).
• Correlative analysis of peripheral blood biomarkers of aging and inflammation (cyclin-dependent kinase inhibitor 2A [p16], inflammatory biomarkers, immunosenescence, micro [mi] ribonucleic acid [RNA]).

OUTLINE:

Patients attend 8 physical therapy visits twice monthly for 4 months or until transplant. Patients also undergo an individualized exercise program at home for 6 months. The program comprises 3 main components: walking over 30 minutes twice a week, strengthening and balance retraining exercise over 30 minutes three times a week.

After completion of study, patients are followed up at 6 months.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with hematologic malignancy receiving care (chemotherapy, immunotherapy, targeted agents, bone marrow transplant, or other) for their hematologic malignancy at the Ohio State University
• Impairments in physical function, as defined by a score < 9 on the SPPB pre-screen
• Medical clearance from an oncologist or primary care physician stating the participant is able to participate in an unsupervised, moderate-intensity physical activity program
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Prisoners
• Any medical condition including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Supportive care (otago exercise programme); Patients attend 8 physical therapy visits twice monthly for 4 months or until transplant. Patients also undergo an individualized exercise program at home for 6 months. The program comprises 3 main components: walking over 30 minutes twice a week, strengthening and balance retraining exercise over 30 minutes three times a week.

Other: Laboratory Biomarker Analysis; Correlative studies; Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Behavioral: Exercise Intervention; Complete individualized exercise program; Procedure: Physical Therapy; Complete individualized exercise program; Other Names: PT; Physiatric Procedure; Physical Medicine Procedure; Physical Therapeutics; Physical Therapy Procedure; Physiotherapy; Physiotherapy Procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Adverse Events (AE), Graded According to Common Terminology Criteria for Adverse Events Version 5.0	Adverse Events and their severity will be captured and graded according to Common Terminology Criteria for Adverse Events Version 5.0, and whether any events can be attributed to exercise.	Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
Percentage of Eligible Patients Completing the OEP	Feasibility defined as 80% of eligible of patients completing the OEP. The proportion of screened patients who agree to participate, the proportion of patients who attend certain percentage of assigned physical therapy (PT) sessions and the proportion of patients who complete the whole study along will be described with respective 95% confidence intervals. Study implementation and challenges will be evaluated by patient exercise logs. Exercise levels at home will also be assessed by exercise diary log	Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarker Expression Levels	Specific biomarkers of aging will be explored to determine a relationship with molecular markers of aging and epigenetic age with a frailty phenotype. mRNA isolates will be analyzed using a nanostring codeset. The regulation levels of killer cell immunoglobulin-like receptors (KIRs) will be reported. Both KIR_Activating_Subgroup_1 and KIR_Activating_Subgroup_2 levels will be reported. Participants are classified based on a frailty scale: favorable (fit patients based on frailty scale), mid (intermediately fit), unfavorable (frail). Negative values indicate a downregulation of gene expression and positive values indicate an upregulation of gene expression.	Study Visit 1 (Baseline), and study visit 3 (6 months)
Change in Geriatric Assessment (GA) Measured Using The Cancer and Aging Research Group (CARG) Geriatric Assessment (G)A-patient Reported Karnofsky Performance Status (KPS) for Patients Undergoing Transplant	Patient-reported KPS31 measures the patients self-reported level of physical function. Scoring extends from 30 (severely disabled) - 100 (normal), with a higher score indicating a higher level of physical function. Descriptive statistics of these measurements will be provided as well as graphs in order to help visualize the change over time.	Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
Change in Geriatric Assessment (GA) Measured Using the CARG GA-patient Reported Karnofsky Performance Status (KPS)	Patient-reported KPS31 measures the patients self-reported level of physical function. Scoring extends from 30 (severely disabled) - 100 (normal), with a higher score indicating a higher level of physical function. Descriptive statistics of these measurements will be provided as well as graphs in order to help visualize the change over time.	Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
Health Related Quality of Life (HRQL) Measured Using the PROMIS	Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale Short Form v1.1 HRQL measures provide information to the clinician regarding the patient experience of treatment or intervention. The PROMIS Global Health Scale has been rigorously tested for reliability and validity and can be applied to all populations, where higher scores reflect improved quality of life. It consists of 10 questions and was given to the patients for self-administration at three intervals. Descriptive statistics of these measurements will be provided as well as graphs in order to help visualize the change over time. 5 point Likert scale higher values represent a better quality of life. PROMIS scores, developed by the NIH, are usually presented as T-scores, where the average score is 50 and a standard deviation is 10.	Study visit 1 (Baseline), Study visit 2 (month 4), and study visit 3 (month 6, completion of study)
Change in HRQL Measured Using the PROMIS for Patients Undergoing Transplant	Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale Short Form v1.1 HRQL measures provide information to the clinician regarding the patient experience of treatment or intervention. The PROMIS Global Health Scale has been rigorously tested for reliability and validity and can be applied to all populations, where higher scores reflect improved quality of life. It consists of 10 questions and was given to the patients for self-administration at three intervals. Descriptive statistics of these measurements will be provided as well as graphs in order to help visualize the change over time. 5 point Likert scale higher values represent a better quality of life. PROMIS scores, developed by the NIH, are usually presented as T-scores, where the average score is 50 and a standard deviation is 10.	Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
Number of Falls (Inpatient and Outpatient)	The total number of falls experienced by participants will be reported. Both falls that occur inpatient and outpatient will be included.	Up to 6 months
Change in Physical Performance Measured Using the Short Physical Performance Battery (SPPB)	Scores are assigned for each of the tests and an aggregate score is assigned ranging from 0-12, with higher scores indicating greater physical function. SPPB scores are classified into 4 categories: very low physical function (0-3); low physical function (4-6); moderate physical function (7-9) and high physical function (10-12). An alpha internal consistency of 0.76 has been reported	Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
Change in Physical Performance Measured Using the SPPB for Patients Undergoing Transplant	Scores are assigned for each of the tests and an aggregate score is assigned ranging from 0-12, with higher scores indicating greater physical function. SPPB scores are classified into 4 categories: very low physical function (0-3); low physical function (4-6); moderate physical function (7-9) and high physical function (10-12). An alpha internal consistency of 0.76 has been reported	Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
Percentage of Patients With Hospital Readmission for Patients Undergoing Transplant	Evaluating the frequency (percentage of patients with hospital re-admissions) within 90 days	At 90 days
Length of Inpatient Stays for Patients Undergoing Transplant	Descriptive statistics of these measurements will be provided as well as graphs in order to help visualize the change over time. The proportion of patients who achieve meaningful change in these scores will be described with 95% confidence intervals. Difference from baseline will be tested with Wilcoxon signed rank test or McNemar's test for continuous or categorical variables respectively.	Up to 6 months

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Ashley Rosko, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

General Publications

• Rosko A, Huang Y, Jones D, Presley CJ, Jaggers J, Owens R, Naughton M, Krok-Schoen JL. Feasibility of implementing an exercise intervention in older adults with hematologic malignancy. J Geriatr Oncol. 2022 Mar;13(2):234-240. doi: 10.1016/j.jgo.2021.07.010. Epub 2021 Aug 24.

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2016
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): January 6, 2019

Study Registration Dates

• First Submitted: June 1, 2016
• First Submitted That Met QC Criteria: June 3, 2016
• First Posted (Estimated): June 7, 2016

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: May 28, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; Hematologic Malignancy; Decreased Physical Activity
• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms; Dermatologic Agents; Keratolytic Agents; Coal Tar
• Other Study ID Numbers: OSU-16016 (Ohio State University Comprehensive Cancer Center); NCI-2016-00446 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No