Trial Outcomes & Findings for A Mobile Health Exercise Intervention for Older Patients With Myeloid Neoplasms (NCT NCT04035499)
NCT ID: NCT04035499
Last Updated: 2026-01-21
Results Overview
Percentage of patients entering any exercise data into the mobile app ≥50% of the study period days, excluding hospitalization
COMPLETED
NA
25 participants
8-12 weeks
2026-01-21
Participant Flow
Participant milestones
| Measure |
Experimental Arm:Single
GO-EXCAP Mobile App involves the use of a mobile app delivery platform to deliver an exercise program \[Exercise for Cancer Patients (EXCAP©®)\]. EXCAP©® is a progressive walking and resistance exercise program
GO-EXCAP Mobile App: A mobile app delivery platform and the EXCAP©® exercise program
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Experimental Arm:Single
GO-EXCAP Mobile App involves the use of a mobile app delivery platform to deliver an exercise program \[Exercise for Cancer Patients (EXCAP©®)\]. EXCAP©® is a progressive walking and resistance exercise program
GO-EXCAP Mobile App: A mobile app delivery platform and the EXCAP©® exercise program
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Post-intervention data were not collected for 3 subjects who completed baseline (2 died, 1 withdrew)
Baseline characteristics by cohort
| Measure |
Experimental Arm:Single
n=25 Participants
GO-EXCAP Mobile App involves the use of a mobile app delivery platform to deliver an exercise program \[Exercise for Cancer Patients (EXCAP©®)\]. EXCAP©® is a progressive walking and resistance exercise program
GO-EXCAP Mobile App: A mobile app delivery platform and the EXCAP©® exercise program
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=25 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=25 Participants
|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 4.9 • n=25 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=25 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=25 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=25 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=25 Participants
|
|
Short Physical Performance Battery at Baseline
|
9.0 score on a scale
STANDARD_DEVIATION 1.7 • n=22 Participants • Post-intervention data were not collected for 3 subjects who completed baseline (2 died, 1 withdrew)
|
|
Brief Fatigue Inventory at Baseline
|
29.4 score on a scale
STANDARD_DEVIATION 20.8 • n=22 Participants • Post-intervention data were not collected for 3 subjects who completed baseline (2 died, 1 withdrew)
|
|
Center for Epidemiologic Studies Depression at Baseline
|
11.7 score on a scale
STANDARD_DEVIATION 7.7 • n=22 Participants • Post-intervention data were not collected for 3 subjects who completed baseline
|
|
Functional Assessment of Cancer Therapy-Leukemia at Baseline
|
123.9 score on a scale
STANDARD_DEVIATION 24.7 • n=22 Participants • Measure Analysis Population Description: Post-intervention data were not collected for 3 subjects who completed baseline (2 died, 1 withdrew)
|
PRIMARY outcome
Timeframe: 8-12 weeksPercentage of patients entering any exercise data into the mobile app ≥50% of the study period days, excluding hospitalization
Outcome measures
| Measure |
Experimental Arm:Single
n=22 Participants
GO-EXCAP Mobile App involves the use of a mobile app delivery platform to deliver an exercise program \[Exercise for Cancer Patients (EXCAP©®)\]. EXCAP©® is a progressive walking and resistance exercise program
GO-EXCAP Mobile App: A mobile app delivery platform and the EXCAP©® exercise program
|
|---|---|
|
Feasibility: Percentage of Patients Entering Any Exercise Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization
% Entering Step Data
|
18 Participants
|
|
Feasibility: Percentage of Patients Entering Any Exercise Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization
% Entering Resistance Data
|
14 Participants
|
PRIMARY outcome
Timeframe: 8-12 weeksPercentage of Patients Entering Resistance Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization
Outcome measures
| Measure |
Experimental Arm:Single
n=22 Participants
GO-EXCAP Mobile App involves the use of a mobile app delivery platform to deliver an exercise program \[Exercise for Cancer Patients (EXCAP©®)\]. EXCAP©® is a progressive walking and resistance exercise program
GO-EXCAP Mobile App: A mobile app delivery platform and the EXCAP©® exercise program
|
|---|---|
|
Feasibility: Percentage of Patients Entering Resistance Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization
|
14 Participants
|
PRIMARY outcome
Timeframe: Week 0, prior to baselinePopulation: Number of potential subjects determined eligible and approached to consent. Patients who consented and subsequently withdrew before baseline assessments also contributed to the numerator.
Recruitment rates (percentage of patients who are approached and subsequently consent).
Outcome measures
| Measure |
Experimental Arm:Single
n=59 Participants
GO-EXCAP Mobile App involves the use of a mobile app delivery platform to deliver an exercise program \[Exercise for Cancer Patients (EXCAP©®)\]. EXCAP©® is a progressive walking and resistance exercise program
GO-EXCAP Mobile App: A mobile app delivery platform and the EXCAP©® exercise program
|
|---|---|
|
Feasibility: Recruitment Rates
|
38 Participants
|
PRIMARY outcome
Timeframe: 8-12 weeksRetention rates (percentage of patients who are enrolled i.e., complete baseline assessments and subsequently complete post-intervention assessments)
Outcome measures
| Measure |
Experimental Arm:Single
n=25 Participants
GO-EXCAP Mobile App involves the use of a mobile app delivery platform to deliver an exercise program \[Exercise for Cancer Patients (EXCAP©®)\]. EXCAP©® is a progressive walking and resistance exercise program
GO-EXCAP Mobile App: A mobile app delivery platform and the EXCAP©® exercise program
|
|---|---|
|
Feasibility: Retention Rates
|
22 Participants
|
SECONDARY outcome
Timeframe: Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks)Changes in physical function measured using the Short Physical Performance Battery (SPPB) which an objective physical assessment evaluating lower extremity physical function (total score ranges from 0-12; higher score indicates better physical function). It is comprised of 3 components: a four-meter walk, repeated chair stands and a balance test (the score for each component ranges from 0-4; scores are summed).
Outcome measures
| Measure |
Experimental Arm:Single
n=22 Participants
GO-EXCAP Mobile App involves the use of a mobile app delivery platform to deliver an exercise program \[Exercise for Cancer Patients (EXCAP©®)\]. EXCAP©® is a progressive walking and resistance exercise program
GO-EXCAP Mobile App: A mobile app delivery platform and the EXCAP©® exercise program
|
|---|---|
|
Pre-post Changes in Short Physical Performance Battery (SPPB)
Changes from baseline to post
|
0.2 score on a scale
Standard Deviation 1.6
|
|
Pre-post Changes in Short Physical Performance Battery (SPPB)
Baseline
|
9.0 score on a scale
Standard Deviation 1.7
|
|
Pre-post Changes in Short Physical Performance Battery (SPPB)
Post-Intervention
|
9.2 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks)Changes in fatigue measures using the Brief Fatigue Inventory (BFI) which is a 9-item, patient-reported instrument. The score for each item ranges from 0-10 (scores are summed; total score ranges from 0-90), a higher score indicates higher self-reported levels of fatigue.
Outcome measures
| Measure |
Experimental Arm:Single
n=22 Participants
GO-EXCAP Mobile App involves the use of a mobile app delivery platform to deliver an exercise program \[Exercise for Cancer Patients (EXCAP©®)\]. EXCAP©® is a progressive walking and resistance exercise program
GO-EXCAP Mobile App: A mobile app delivery platform and the EXCAP©® exercise program
|
|---|---|
|
Pre-post Changes in Brief Fatigue Inventory (BFI)
Baseline
|
29.4 score on a scale
Standard Deviation 20.8
|
|
Pre-post Changes in Brief Fatigue Inventory (BFI)
Post-Intervention
|
23.2 score on a scale
Standard Deviation 18.8
|
|
Pre-post Changes in Brief Fatigue Inventory (BFI)
Changes from baseline to post
|
-6.2 score on a scale
Standard Deviation 17.9
|
SECONDARY outcome
Timeframe: 8-12 weeksChanges in depression measured using the Center for Epidemiological Studies Depression Scale (CES-D) which is a 20-item depression scale. The score for each item ranges from 0-3 (scores are summed; total score ranges from 0-60), a higher score indicates higher self-reported depression levels.
Outcome measures
| Measure |
Experimental Arm:Single
n=22 Participants
GO-EXCAP Mobile App involves the use of a mobile app delivery platform to deliver an exercise program \[Exercise for Cancer Patients (EXCAP©®)\]. EXCAP©® is a progressive walking and resistance exercise program
GO-EXCAP Mobile App: A mobile app delivery platform and the EXCAP©® exercise program
|
|---|---|
|
Pre-post Changes in the Center for Epidemiological Studies Depression Scale (CES-D)
Baseline
|
11.7 score on a scale
Standard Deviation 7.7
|
|
Pre-post Changes in the Center for Epidemiological Studies Depression Scale (CES-D)
Post-Intervention
|
11.1 score on a scale
Standard Deviation 8.0
|
|
Pre-post Changes in the Center for Epidemiological Studies Depression Scale (CES-D)
Changes from Baseline to Post
|
-0.6 score on a scale
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks)Changes in quality of life measured using the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) scale. It consists of 44 items divided into 5 subscales: physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), functional well-being (FWB) and leukemia-specific concerns. The score for each item ranges from 0-4 (total score ranges from 0-176). After reversing the scoring of negatively worded items, all the scores are summated. A higher score indicates better quality of life.
Outcome measures
| Measure |
Experimental Arm:Single
n=22 Participants
GO-EXCAP Mobile App involves the use of a mobile app delivery platform to deliver an exercise program \[Exercise for Cancer Patients (EXCAP©®)\]. EXCAP©® is a progressive walking and resistance exercise program
GO-EXCAP Mobile App: A mobile app delivery platform and the EXCAP©® exercise program
|
|---|---|
|
Pre-post Changes in Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)
Post-Intervention
|
127.1 score on a scale
Standard Deviation 22.9
|
|
Pre-post Changes in Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)
Changes from baseline to post
|
3.2 score on a scale
Standard Deviation 18.1
|
|
Pre-post Changes in Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)
Baseline
|
123.9 score on a scale
Standard Deviation 24.7
|
Adverse Events
Experimental Arm:Single
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place