Exercise Prehab in Older Adults With Hematologic Malignancies

Hematopoietic and Lymphoid Cell Neoplasm Clinical Trial

Official title:

Maintaining Fitness: Exercise in Patients With Hematologic Malignancy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02791737
• Other study ID #: OSU-16016
• Secondary ID: NCI-2016-00446OS
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2016
• Est. completion date: December 2020

Study information

• Verified date: June 2019
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematopoietic and Lymphoid Cell Neoplasm
• Neoplasms

Intervention

Behavioral:
• Exercise Intervention
Complete individualized exercise program

Other:
• Laboratory Biomarker Analysis
Correlative studies

Procedure:
• Physical Therapy
Complete individualized exercise program

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	The Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AE), graded according to Common Terminology Criteria for Adverse Events version 4.0	AEs and their severity will be captured, and whether any AEs can be attributed to exercise.	Up to 6 months
Primary	Percentage of eligible of participants completing the OEP	Feasibility defined as 80% of eligible of participants 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	Up to 6 months
Secondary	Change in biomarker expression levels	Descriptive statistics of biomarker (p16) expression levels will be provided at different time points to quantify the change over time. The biomarker (p16) expression will be correlated with other outcome measures using either Spearman correlation coefficients or Wilcoxon rank sum tests for continuous and categorical variables respectively. Generalized linear models will be used to assess the impact of p16 expression on GA scores depending on data completeness.	Baseline to up to 6 months
Secondary	Change in GA measured using the CARG GA for patients undergoing transplant	CARG GA scores and their potential association with these clinical endpoints will be explored graphically.	Baseline to up to 6 months
Secondary	Change in geriatric assessment (GA) measured using the CARG GA	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.	Baseline to up to 6 months
Secondary	Change in HRQL measured using the PROMIS	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.	Baseline to up to 6 months
Secondary	Change in HRQL measured using the PROMIS for patients undergoing transplant	PROMIS HRQL scores and their potential association with these clinical endpoints will be explored graphically.	Baseline to up to 6 months
Secondary	Change in number of falls	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.	Baseline to up to 6 months
Secondary	Change in physical performance measured using the SPPB	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.	Baseline to up to 6 months
Secondary	Change in physical performance measured using the SPPB for patients undergoing transplant	SPPB scores and their potential association with these clinical endpoints will be explored graphically.	Baseline to up to 6 months
Secondary	Hospital readmission rate 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.	At 90 days
Secondary	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
Secondary	Number of inpatient falls 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

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