Hematopoietic and Lymphoid Cell NeoplasmNCT02791737
Exercise Prehab in Older Adults With Hematologic Malignancies
A study testing Exercise Intervention, Laboratory Biomarker Analysis and Physical Therapy in people with Hematopoietic and Lymphoid Cell Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm
- What is being tested?
- Exercise Intervention, Laboratory Biomarker Analysis and Physical Therapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2016to 6 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Maintaining Fitness: Exercise in Patients With Hematologic Malignancy
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Being tested
- Exercise Intervention, Laboratory Biomarker Analysis, Physical Therapy, Quality-of-Life Assessment, Questionnaire Administration
- Keywords
- Hematologic Malignancy, Exercise, Decreased Physical Activity
- Medical subject headings
- Hematologic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
Complete individualized exercise program
Laboratory Biomarker AnalysisOther
Correlative studies
Physical TherapyProcedure or surgery
Also called Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure
Complete individualized exercise program
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (otago exercise programme) | Experimental | 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. Receives: Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Procedure: Physical Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Adverse Events (AE), Graded According to Common Terminology Criteria for Adverse Events Version 5.0
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.
Measured: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
Percentage of Eligible Patients Completing the OEP
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
Measured: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
Secondary outcomes (10)
Biomarker Expression Levels
Specific biomarkers of aging will be explored to determine a relationship with molecular markers of aging and epigenetic age with a frailty phenotype. mRNA isolates will be analyzed using a nanostring codeset. The regulation levels of killer cell immunoglobulin-like receptors (KIRs) will be reported. Both KIR_Activating_Subgroup_1 and KIR_Activating_Subgroup_2 levels will be reported. Participants are classified based on a frailty scale: favorable (fit patients based on frailty scale), mid (intermediately fit), unfavorable (frail). Negative values indicate a downregulation of gene expression and positive values indicate an upregulation of gene expression.
Measured: 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
Patient-reported KPS31 measures the patients self-reported level of physical function. Scoring extends from 30 (severely disabled) - 100 (normal), with a higher score indicating a higher level of physical function. Descriptive statistics of these measurements will be provided as well as graphs in order to help visualize the change over time.
Measured: 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)
Patient-reported KPS31 measures the patients self-reported level of physical function. Scoring extends from 30 (severely disabled) - 100 (normal), with a higher score indicating a higher level of physical function. Descriptive statistics of these measurements will be provided as well as graphs in order to help visualize the change over time.
Measured: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
Health Related Quality of Life (HRQL) Measured Using the PROMIS
Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale Short Form v1.1 HRQL measures provide information to the clinician regarding the patient experience of treatment or intervention. The PROMIS Global Health Scale has been rigorously tested for reliability and validity and can be applied to all populations, where higher scores reflect improved quality of life. It consists of 10 questions and was given to the patients for self-administration at three intervals. Descriptive statistics of these measurements will be provided as well as graphs in order to help visualize the change over time. 5 point Likert scale higher values represent a better quality of life. PROMIS scores, developed by the NIH, are usually presented as T-scores, where the average score is 50 and a standard deviation is 10.
Measured: 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
Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale Short Form v1.1 HRQL measures provide information to the clinician regarding the patient experience of treatment or intervention. The PROMIS Global Health Scale has been rigorously tested for reliability and validity and can be applied to all populations, where higher scores reflect improved quality of life. It consists of 10 questions and was given to the patients for self-administration at three intervals. Descriptive statistics of these measurements will be provided as well as graphs in order to help visualize the change over time. 5 point Likert scale higher values represent a better quality of life. PROMIS scores, developed by the NIH, are usually presented as T-scores, where the average score is 50 and a standard deviation is 10.
Measured: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
Number of Falls (Inpatient and Outpatient)
The total number of falls experienced by participants will be reported. Both falls that occur inpatient and outpatient will be included.
Measured: Up to 6 months
Change in Physical Performance Measured Using the Short Physical Performance Battery (SPPB)
Scores are assigned for each of the tests and an aggregate score is assigned ranging from 0-12, with higher scores indicating greater physical function. SPPB scores are classified into 4 categories: very low physical function (0-3); low physical function (4-6); moderate physical function (7-9) and high physical function (10-12). An alpha internal consistency of 0.76 has been reported
Measured: 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
Scores are assigned for each of the tests and an aggregate score is assigned ranging from 0-12, with higher scores indicating greater physical function. SPPB scores are classified into 4 categories: very low physical function (0-3); low physical function (4-6); moderate physical function (7-9) and high physical function (10-12). An alpha internal consistency of 0.76 has been reported
Measured: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
Percentage of Patients With Hospital Readmission for Patients Undergoing Transplant
Evaluating the frequency (percentage of patients with hospital re-admissions) within 90 days
Measured: At 90 days
Length of Inpatient Stays for Patients Undergoing Transplant
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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study start15 Aug 2016
- Primary completion31 Jul 2018
- Study completion6 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashley Rosko, Ohio State University Comprehensive Cancer Center
- Investigators
- Ashley Rosko, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791737
- Sponsor's protocol ID
- OSU-16016
- Other IDs
- NCI-2016-00446
- Status last verified
- May 2025
- First submitted
- 1 Jun 2016
- Last updated
- 13 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34446377
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintaining Fitness: Exercise in Patients With Hematologic Malignancy
- ClinicalTrials.gov ID
- NCT02791737
- Acronym / sponsor ID
- OSU-16016
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Keywords
- Hematologic Malignancy, Exercise, Decreased Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 15 Aug 2016 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 6 Jan 2019 (actual)
- First posted
- 7 Jun 2016 (estimated)
- Results
- Posted 13 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (otago exercise programme) | Experimental | Behavioral: Exercise Intervention, Other: Laboratory Biomarker Analysis, Procedure: Physical Therapy, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionComplete individualized exercise program | Behavioural | Supportive care (otago exercise programme) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Supportive care (otago exercise programme) |
| Physical TherapyAlso: Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy ProcedureComplete individualized exercise program | Procedure or surgery | Supportive care (otago exercise programme) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive care (otago exercise programme) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (otago exercise programme) |
Primary outcome
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
10 secondary outcomes
Biomarker Expression Levels
Time frame: 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
Time frame: 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)
Time frame: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
Health Related Quality of Life (HRQL) Measured Using the PROMIS
Time frame: 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
Time frame: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
Number of Falls (Inpatient and Outpatient)
Time frame: Up to 6 months
Change in Physical Performance Measured Using the Short Physical Performance Battery (SPPB)
Time frame: 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
Time frame: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
Percentage of Patients With Hospital Readmission for Patients Undergoing Transplant
Time frame: At 90 days
Length of Inpatient Stays for Patients Undergoing Transplant
Time frame: Up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34446377Rosko 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.
- The JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley Rosko, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention, Laboratory Biomarker Analysis and Physical Therapy in people with Hematopoietic and Lymphoid Cell Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02791737, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.