Maintaining Fitness: Exercise in Patients With Hematologic Malignancy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Number of Patients With Adverse Events (AE), Graded According to Common Terminology Criteria for Adverse Events Version 5.0
Study Overview
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]).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Exercise Intervention (Behavioral)
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.
Intervention: Laboratory Biomarker Analysis (Other)
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.
Intervention: Physical Therapy (Procedure)
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.
Intervention: Quality-of-Life Assessment (Other)
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.
Intervention: Questionnaire Administration (Other)
Outcomes
Primary Outcomes
Number of Patients With Adverse Events (AE), Graded According to Common Terminology Criteria for Adverse Events Version 5.0
Time Frame: 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
Time Frame: 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 Outcomes
- Biomarker Expression Levels(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(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)(Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months))
- 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))
- 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))
- Number of Falls (Inpatient and Outpatient)(Up to 6 months)
- 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))
- 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))
- Percentage of Patients With Hospital Readmission for Patients Undergoing Transplant(At 90 days)
- Length of Inpatient Stays for Patients Undergoing Transplant(Up to 6 months)
Investigators
Ashley Rosko
Principal Investigator
Ohio State University Comprehensive Cancer Center