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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

8-12 weeks

Results posted on

2026-01-21

Participant Flow

Participant milestones

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

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

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 weeks

Percentage of patients entering any exercise data into the mobile app ≥50% of the study period days, excluding hospitalization

Outcome measures

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 weeks

Percentage of Patients Entering Resistance Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization

Outcome measures

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 baseline

Population: 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

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 weeks

Retention rates (percentage of patients who are enrolled i.e., complete baseline assessments and subsequently complete post-intervention assessments)

Outcome measures

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

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

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 weeks

Changes 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

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

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 events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kah Poh Loh

University of Rochester Medical Center

Phone: 585-276-4353

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place