Exercise Prehab in Older Adults With Hematologic Malignancies
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Interventions
- Behavioral: Exercise InterventionOther: Laboratory Biomarker AnalysisProcedure: Physical TherapyOther: Quality-of-Life AssessmentOther: Questionnaire Administration
- Registration Number
- NCT02791737
- 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
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
- Arm && Interventions
Group Intervention Description Supportive care (otago exercise programme) Physical Therapy 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. Supportive care (otago exercise programme) Questionnaire Administration 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. Supportive care (otago exercise programme) Laboratory Biomarker Analysis 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. Supportive care (otago exercise programme) Exercise Intervention 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. Supportive care (otago exercise programme) Quality-of-Life Assessment 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.
- Primary Outcome Measures
Name Time Method Incidence of adverse events (AE), graded according to Common Terminology Criteria for Adverse Events version 4.0 Up to 6 months AEs and their severity will be captured, and whether any AEs can be attributed to exercise.
Percentage of eligible of participants completing the OEP Up to 6 months 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
- Secondary Outcome Measures
Name Time Method Change in number of falls Baseline to 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.
Change in biomarker expression levels Baseline to up to 6 months 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.
Change in GA measured using the CARG GA for patients undergoing transplant Baseline to up to 6 months CARG GA scores and their potential association with these clinical endpoints will be explored graphically.
Change in HRQL measured using the PROMIS Baseline to 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.
Change in HRQL measured using the PROMIS for patients undergoing transplant Baseline to up to 6 months PROMIS HRQL scores and their potential association with these clinical endpoints will be explored graphically.
Change in geriatric assessment (GA) measured using the CARG GA Baseline to 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.
Change in physical performance measured using the SPPB Baseline to 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.
Change in physical performance measured using the SPPB for patients undergoing transplant Baseline to up to 6 months SPPB scores and their potential association with these clinical endpoints will be explored graphically.
Hospital readmission rate for patients undergoing transplant At 90 days 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.
Number of inpatient falls 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.
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