Exercise Prehab in Older Adults With Hematologic Malignancies

Not Applicable

Completed

Conditions: Hematopoietic and Lymphoid Cell Neoplasm

Registration Number: NCT02791737

Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Patients With Adverse Events (AE), Graded According to Common Terminology Criteria for Adverse Events Version 5.0	Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)	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.
Percentage of Eligible Patients Completing the OEP	Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)	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

Secondary Outcome Measures

Name	Time	Method
Biomarker Expression Levels	Study Visit 1 (Baseline), and study visit 3 (6 months)	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.
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	Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)	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.
Change in Geriatric Assessment (GA) Measured Using the CARG GA-patient Reported Karnofsky Performance Status (KPS)	Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)	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.
Health Related Quality of Life (HRQL) Measured Using the PROMIS	Study visit 1 (Baseline), Study visit 2 (month 4), and study visit 3 (month 6, completion of study)	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.
Change in HRQL Measured Using the PROMIS for Patients Undergoing Transplant	Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)	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.
Number of Falls (Inpatient and Outpatient)	Up to 6 months	The total number of falls experienced by participants will be reported. Both falls that occur inpatient and outpatient will be included.
Change in Physical Performance Measured Using the Short Physical Performance Battery (SPPB)	Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)	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
Change in Physical Performance Measured Using the SPPB for Patients Undergoing Transplant	Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)	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
Percentage of Patients With Hospital Readmission for Patients Undergoing Transplant	At 90 days	Evaluating the frequency (percentage of patients with hospital re-admissions) within 90 days
Length of Inpatient Stays for Patients Undergoing Transplant	Up to 6 months	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.

Trial Locations

Locations (1): The Ohio State University Comprehensive Cancer Center
🇺🇸
Columbus, Ohio, United States
The Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States