Exercise Prehab in Older Adults With Hematologic Malignancies

NCT ID: NCT02791737

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-15
• Study Completion Date: 2019-01-06

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise Intervention

Intervention Type: BEHAVIORAL

Complete individualized exercise program

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Physical Therapy

Intervention Type: PROCEDURE

Complete individualized exercise program

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Exercise Intervention

Complete individualized exercise program

Intervention Type: BEHAVIORAL

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Physical Therapy

Complete individualized exercise program

Intervention Type: PROCEDURE

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Physiatric Procedure; Physical Medicine Procedure; Physical Therapeutics; Physical Therapy Procedure; Physiotherapy; Physiotherapy Procedure; PT; Quality of Life Assessment

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Ashley Rosko

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashley Rosko, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34446377 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

http://cancer.osu.edu

The Jamesline

Other Identifiers

NCI-2016-00446

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-16016

Identifier Type: -

Identifier Source: org_study_id