Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Structured Exercise Program Intervention in Improving Physical Activity in Older Patients with Hematologic Malignancies Undergoing Cancer Therapy

Protocol: OSU-16016

Full Title

Maintaining Fitness: Exercise in Patients with Hematologic Malignancy

Purpose

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 Objective

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.

Are you eligible?

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