Trial Outcomes & Findings for Exercise Prehab in Older Adults With Hematologic Malignancies (NCT NCT02791737)
NCT ID: NCT02791737
Last Updated: 2025-06-13
Results Overview
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.
COMPLETED
NA
30 participants
Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)
2025-06-13
Participant Flow
Potential participants were recruited from the hematology clinics at The Ohio State University Comprehensive Cancer Center August 2016 to January 2018.
Participant milestones
| Measure |
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.
Exercise Intervention: Complete individualized exercise program
Laboratory Biomarker Analysis: Correlative studies
Physical Therapy: Complete individualized exercise program
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exercise Prehab in Older Adults With Hematologic Malignancies
Baseline characteristics by cohort
| Measure |
Supportive Care (Otago Exercise Programme)
n=30 Participants
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.
Exercise Intervention: Complete individualized exercise program
Laboratory Biomarker Analysis: Correlative studies
Physical Therapy: Complete individualized exercise program
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Age, Customized
|
75.5 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Supportive Care (Otago Exercise Programme)
n=30 Participants
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.
Exercise Intervention: Complete individualized exercise program
Laboratory Biomarker Analysis: Correlative studies
Physical Therapy: Complete individualized exercise program
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Number of Patients With Adverse Events (AE), Graded According to Common Terminology Criteria for Adverse Events Version 5.0
|
0 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Supportive Care (Otago Exercise Programme)
n=30 Participants
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.
Exercise Intervention: Complete individualized exercise program
Laboratory Biomarker Analysis: Correlative studies
Physical Therapy: Complete individualized exercise program
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Percentage of Eligible Patients Completing the OEP
|
66.7 percent of patients
|
SECONDARY outcome
Timeframe: Study Visit 1 (Baseline), and study visit 3 (6 months)Population: number analyzed is the number of patients that fit into each category: unfavorable, mid, and favorable.
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.
Outcome measures
| Measure |
Supportive Care (Otago Exercise Programme)
n=26 Participants
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.
Exercise Intervention: Complete individualized exercise program
Laboratory Biomarker Analysis: Correlative studies
Physical Therapy: Complete individualized exercise program
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Biomarker Expression Levels
KIR_Activating _Subgroup_1 Unfavorable median
|
1.26 cycle threshold
Interval -0.42 to 2.33
|
|
Biomarker Expression Levels
KIR_Activating _Subgroup_1 Mid median
|
-0.19 cycle threshold
Interval -2.69 to 2.79
|
|
Biomarker Expression Levels
KIR_Activating _Subgroup_1 Favorable median
|
0.15 cycle threshold
Interval -0.42 to 2.33
|
|
Biomarker Expression Levels
KIR_Activating_Subgroup_2 Unfavorable median
|
0.62 cycle threshold
Interval -0.54 to 1.2
|
|
Biomarker Expression Levels
KIR_Activating _Subgroup_2 Mid median
|
-0.05 cycle threshold
Interval -2.82 to 1.18
|
|
Biomarker Expression Levels
KIR_Activating _Subgroup_2 Favorable median
|
0.20 cycle threshold
Interval -0.54 to 1.86
|
SECONDARY outcome
Timeframe: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)Population: only 7 patients had transplants
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.
Outcome measures
| Measure |
Supportive Care (Otago Exercise Programme)
n=7 Participants
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.
Exercise Intervention: Complete individualized exercise program
Laboratory Biomarker Analysis: Correlative studies
Physical Therapy: Complete individualized exercise program
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
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
Visit 1
|
80 score on a scale
Interval 40.0 to 100.0
|
|
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
Visit 2
|
85 score on a scale
Interval 60.0 to 100.0
|
|
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
Visit 3
|
90 score on a scale
Interval 60.0 to 100.0
|
SECONDARY outcome
Timeframe: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)Population: Patients did not complete all visits
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.
Outcome measures
| Measure |
Supportive Care (Otago Exercise Programme)
n=30 Participants
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.
Exercise Intervention: Complete individualized exercise program
Laboratory Biomarker Analysis: Correlative studies
Physical Therapy: Complete individualized exercise program
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Change in Geriatric Assessment (GA) Measured Using the CARG GA-patient Reported Karnofsky Performance Status (KPS)
Visit 2
|
90 score on a scale
Interval 60.0 to 100.0
|
|
Change in Geriatric Assessment (GA) Measured Using the CARG GA-patient Reported Karnofsky Performance Status (KPS)
Visit 1
|
80 score on a scale
Interval 40.0 to 100.0
|
|
Change in Geriatric Assessment (GA) Measured Using the CARG GA-patient Reported Karnofsky Performance Status (KPS)
Visit 3
|
90 score on a scale
Interval 50.0 to 100.0
|
SECONDARY outcome
Timeframe: Study visit 1 (Baseline), Study visit 2 (month 4), and study visit 3 (month 6, completion of study)Population: Patients did not complete all visits
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.
Outcome measures
| Measure |
Supportive Care (Otago Exercise Programme)
n=30 Participants
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.
Exercise Intervention: Complete individualized exercise program
Laboratory Biomarker Analysis: Correlative studies
Physical Therapy: Complete individualized exercise program
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Health Related Quality of Life (HRQL) Measured Using the PROMIS
Visit 1
|
32.4 score on a scale
Interval 19.9 to 47.7
|
|
Health Related Quality of Life (HRQL) Measured Using the PROMIS
Visit 2
|
34.9 score on a scale
Interval 26.7 to 47.7
|
|
Health Related Quality of Life (HRQL) Measured Using the PROMIS
Visit 3
|
36.2 score on a scale
Interval 19.9 to 47.7
|
SECONDARY outcome
Timeframe: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)Population: only 7 patients received transplants
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.
Outcome measures
| Measure |
Supportive Care (Otago Exercise Programme)
n=7 Participants
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.
Exercise Intervention: Complete individualized exercise program
Laboratory Biomarker Analysis: Correlative studies
Physical Therapy: Complete individualized exercise program
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Change in HRQL Measured Using the PROMIS for Patients Undergoing Transplant
Visit 1
|
34.9 score on a scale
Interval 23.5 to 47.7
|
|
Change in HRQL Measured Using the PROMIS for Patients Undergoing Transplant
Visit 2
|
36.2 score on a scale
Interval 29.6 to 42.3
|
|
Change in HRQL Measured Using the PROMIS for Patients Undergoing Transplant
Visit 3
|
34.9 score on a scale
Interval 32.4 to 39.8
|
SECONDARY outcome
Timeframe: Up to 6 monthsThe total number of falls experienced by participants will be reported. Both falls that occur inpatient and outpatient will be included.
Outcome measures
| Measure |
Supportive Care (Otago Exercise Programme)
n=30 Participants
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.
Exercise Intervention: Complete individualized exercise program
Laboratory Biomarker Analysis: Correlative studies
Physical Therapy: Complete individualized exercise program
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Number of Falls (Inpatient and Outpatient)
|
3 number of falls
|
SECONDARY outcome
Timeframe: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)Population: Patients did not complete all visits
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
Outcome measures
| Measure |
Supportive Care (Otago Exercise Programme)
n=30 Participants
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.
Exercise Intervention: Complete individualized exercise program
Laboratory Biomarker Analysis: Correlative studies
Physical Therapy: Complete individualized exercise program
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Change in Physical Performance Measured Using the Short Physical Performance Battery (SPPB)
Visit 1
|
7 units on a scale
Interval 0.0 to 11.0
|
|
Change in Physical Performance Measured Using the Short Physical Performance Battery (SPPB)
Visit 2
|
11 units on a scale
Interval 4.0 to 12.0
|
|
Change in Physical Performance Measured Using the Short Physical Performance Battery (SPPB)
Visit 3
|
9 units on a scale
Interval 2.0 to 12.0
|
SECONDARY outcome
Timeframe: Study Visit 1 (Baseline) Study Visit 2 (4 months) Study Visit 3 (6 months)Population: only 7 patients received 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
Outcome measures
| Measure |
Supportive Care (Otago Exercise Programme)
n=7 Participants
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.
Exercise Intervention: Complete individualized exercise program
Laboratory Biomarker Analysis: Correlative studies
Physical Therapy: Complete individualized exercise program
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Change in Physical Performance Measured Using the SPPB for Patients Undergoing Transplant
Visit 1
|
8 units on a scale
Interval 0.0 to 10.0
|
|
Change in Physical Performance Measured Using the SPPB for Patients Undergoing Transplant
Visit 2
|
11.5 units on a scale
Interval 10.0 to 12.0
|
|
Change in Physical Performance Measured Using the SPPB for Patients Undergoing Transplant
Visit 3
|
10 units on a scale
Interval 2.0 to 12.0
|
SECONDARY outcome
Timeframe: At 90 daysEvaluating the frequency (percentage of patients with hospital re-admissions) within 90 days
Outcome measures
| Measure |
Supportive Care (Otago Exercise Programme)
n=7 Participants
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.
Exercise Intervention: Complete individualized exercise program
Laboratory Biomarker Analysis: Correlative studies
Physical Therapy: Complete individualized exercise program
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Percentage of Patients With Hospital Readmission for Patients Undergoing Transplant
|
42.9 percentage of patients
|
SECONDARY outcome
Timeframe: Up to 6 monthsDescriptive 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.
Outcome measures
| Measure |
Supportive Care (Otago Exercise Programme)
n=3 Participants
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.
Exercise Intervention: Complete individualized exercise program
Laboratory Biomarker Analysis: Correlative studies
Physical Therapy: Complete individualized exercise program
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Length of Inpatient Stays for Patients Undergoing Transplant
|
18 days
Interval 16.0 to 18.0
|
Adverse Events
Supportive Care (Otago Exercise Programme)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ashley Rosko
The Ohio State University Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place