Clinical trial NCT02791737: Exercise Prehab in Older Adults With Hematologic Malignancies
Official title: Maintaining Fitness: Exercise in Patients With Hematologic Malignancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Keywords: Hematologic Malignancy
Exercise
Decreased Physical Activity
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-06-07
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients With Adverse Events (AE), Graded According to Common Terminology Criteria for Adverse Events Version 5.0
timeFrame: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
measure: Percentage of Eligible Patients Completing the OEP
timeFrame: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
Secondary outcomes:
measure: Biomarker Expression Levels
timeFrame: Study Visit 1 (Baseline), and study visit 3 (6 months)
measure: 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
timeFrame: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
measure: Change in Geriatric Assessment (GA) Measured Using the CARG GA-patient Reported Karnofsky Performance Status (KPS)
timeFrame: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
measure: Health Related Quality of Life (HRQL) Measured Using the PROMIS
timeFrame: Study visit 1 (Baseline), Study visit 2 (month 4), and study visit 3 (month 6, completion of study)
measure: Change in HRQL Measured Using the PROMIS for Patients Undergoing Transplant
timeFrame: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
measure: Number of Falls (Inpatient and Outpatient)
timeFrame: Up to 6 months
measure: Change in Physical Performance Measured Using the Short Physical Performance Battery (SPPB)
timeFrame: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
measure: Change in Physical Performance Measured Using the SPPB for Patients Undergoing Transplant
timeFrame: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
measure: Percentage of Patients With Hospital Readmission for Patients Undergoing Transplant
timeFrame: At 90 days
measure: Length of Inpatient Stays for Patients Undergoing Transplant
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Ashley Rosko, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosko A, Huang Y, Jones D, Presley CJ, Jaggers J, Owens R, Naughton M, Krok-Schoen JL. Feasibility of implementing an exercise intervention in older adults with hematologic malignancy. J Geriatr Oncol. 2022 Mar;13(2):234-240. doi: 10.1016/j.jgo.2021.07.010. Epub 2021 Aug 24.