Trial Outcomes & Findings for Tailored Home-Based Exercise Program for Multiple Chronic Conditions (NCT NCT03874754)

Last Updated: 2025-10-14

Results Overview

Fatigue was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0-Fatigue 6a. This 6-item measure covers fatigue frequency, duration, intensity, and impact on daily activities. Responses were summed to generate a raw score (range 6-30), which was converted to a standardized T-score (mean = 50, SD = 10) based on the U.S. general population. Higher T-scores indicate greater fatigue (worse outcome). The reported outcome is the change in PROMIS Fatigue T-score from baseline to completion, where negative values indicate improvement.

Recruitment status

COMPLETED

Study phase

Target enrollment

34 participants

Primary outcome timeframe

Pre- and post-intervention, up to 12 weeks

Results posted on

2025-10-14

Participant Flow

Participant milestones

Participant milestones
Measure	The iHBE Program Group Tailored Technology-Enhance Home-based exercise program (iHBE): The tailored technology-enhanced home-based exercise (iHBE) program is a 12-week program with 1 assessment home visit session, 2 home visits on the first and last week of the program and 10 weekly phone follow up. Participants were asked to choose their methods of exercise and set up weekly goals for exercise with the researcher. The technologies, a wearable device, and a smartphone application were used as a tool to monitor physical performance (heart rate \[HR\], step count), provide immediate feedback, and send daily reminding messages through Mobile Ecological Momentary Assessment (mEMA). The physical performance and goals were reviewed and adjusted by both participant and researcher weekly.	Usual Care (Control Group) Participants were required to wear physical activity tracker (Fitbit) and respond to the daily symptoms survey (mEMA) while receiving usual care
Overall Study STARTED	22	12
Overall Study COMPLETED	14	6
Overall Study NOT COMPLETED	8	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tailored Home-Based Exercise Program for Multiple Chronic Conditions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	The iHBE Program Group n=22 Participants Tailored Technology-Enhance Home-based exercise program (iHBE): The tailored technology-enhanced home-based exercise (iHBE) program is a 12-week program with 1 assessment home visit session, 2 home visits on the first and last week of the program and 10 weekly phone follow up. Participants were asked to choose their methods of exercise and set up weekly goals for exercise with the researcher. The technologies, a wearable device, and a smartphone application were used as a tool to monitor physical performance (heart rate \[HR\], step count), provide immediate feedback, and send daily reminding messages through Mobile Ecological Momentary Assessment (mEMA). The physical performance and goals were reviewed and adjusted by both participant and researcher weekly.	Usual Care (Control Group) n=12 Participants Participants were required to wear physical activity tracker (Fitbit) and respond to the daily symptoms survey (mEMA) while receiving usual care	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants	11 Participants n=7 Participants	31 Participants n=5 Participants
Age, Continuous	72.73 years STANDARD_DEVIATION 7.69 • n=5 Participants	74 years STANDARD_DEVIATION 4.79 • n=7 Participants	73.18 years STANDARD_DEVIATION 6.75 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	12 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	22 Participants n=5 Participants	12 Participants n=7 Participants	34 Participants n=5 Participants
Fatigue	52.64 T-score STANDARD_DEVIATION 9.89 • n=5 Participants	45.17 T-score STANDARD_DEVIATION 7.93 • n=7 Participants	50.15 T-score STANDARD_DEVIATION 9.81 • n=5 Participants
Resilience	35.56 units on a scale STANDARD_DEVIATION 7.32 • n=5 Participants	38.11 units on a scale STANDARD_DEVIATION 8.43 • n=7 Participants	36.41 units on a scale STANDARD_DEVIATION 7.64 • n=5 Participants
Physical well-being	42.52 units on a scale STANDARD_DEVIATION 28.20 • n=5 Participants	54.37 units on a scale STANDARD_DEVIATION 32.40 • n=7 Participants	48.44 units on a scale STANDARD_DEVIATION 30.09 • n=5 Participants
Mental well-being	73.66 units on a scale STANDARD_DEVIATION 16.25 • n=5 Participants	54.15 units on a scale STANDARD_DEVIATION 38.50 • n=7 Participants	63.91 units on a scale STANDARD_DEVIATION 30.37 • n=5 Participants

PRIMARY outcome

Timeframe: Pre- and post-intervention, up to 12 weeks

Outcome measures

Outcome measures
Measure	The iHBE Program Group n=22 Participants Tailored Technology-Enhance Home-based exercise program (iHBE): The tailored technology-enhanced home-based exercise (iHBE) program is a 12-week program with 1 assessment home visit session, 2 home visits on the first and last week of the program and 10 weekly phone follow up. Participants were asked to choose their methods of exercise and set up weekly goals for exercise with the researcher. The technologies, a wearable device, and a smartphone application were used as a tool to monitor physical performance (heart rate \[HR\], step count), provide immediate feedback, and send daily reminding messages through Mobile Ecological Momentary Assessment (mEMA). The physical performance and goals were reviewed and adjusted by both participant and researcher weekly.	Usual Care (Control Group) n=12 Participants Participants were required to wear physical activity tracker (Fitbit) and respond to the daily symptoms survey (mEMA) while receiving usual care
Change in Fatigue as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0-Fatigue 6a	-1.61 T-score Standard Deviation 6.75	4.26 T-score Standard Deviation 7.95

PRIMARY outcome

Timeframe: Pre- and post-intervention, up to 12 weeks

Resilience was assessed using the Connor-Davidson Resilience Scale (CD-RISC; 10 items). Each item is rated on a 5-point Likert scale (0 = not true at all to 4 = true nearly all the time). Raw scores are summed to produce a total score ranging from 0 to 40, with higher scores indicating greater resilience (better outcome). The reported outcome is the mean change in raw score, calculated as the score at the completion time point (12 weeks) minus the score at baseline. Positive values indicate improvement in resilience.

Outcome measures

Outcome measures
Measure	The iHBE Program Group n=22 Participants Tailored Technology-Enhance Home-based exercise program (iHBE): The tailored technology-enhanced home-based exercise (iHBE) program is a 12-week program with 1 assessment home visit session, 2 home visits on the first and last week of the program and 10 weekly phone follow up. Participants were asked to choose their methods of exercise and set up weekly goals for exercise with the researcher. The technologies, a wearable device, and a smartphone application were used as a tool to monitor physical performance (heart rate \[HR\], step count), provide immediate feedback, and send daily reminding messages through Mobile Ecological Momentary Assessment (mEMA). The physical performance and goals were reviewed and adjusted by both participant and researcher weekly.	Usual Care (Control Group) n=12 Participants Participants were required to wear physical activity tracker (Fitbit) and respond to the daily symptoms survey (mEMA) while receiving usual care
Change in Resilience as Assessed by Connor-Davidson Resilience Scale	0.00 score on a scale Standard Deviation 4.97	0.89 score on a scale Standard Deviation 6.41

PRIMARY outcome

Timeframe: Pre- and post-intervention, up to 12 weeks

Physical well-being was assessed using the 36-Item Short Form Health Survey (SF-36). The measure was derived from the physical functioning, role-physical, and bodily pain domains. Each domain is scored from 0 to 100, with higher scores indicating better physical health. The reported outcome is the mean change in the averaged domain scores from baseline to completion. Positive values indicate improvement in physical well-being.

Outcome measures

Outcome measures
Measure	The iHBE Program Group n=22 Participants Tailored Technology-Enhance Home-based exercise program (iHBE): The tailored technology-enhanced home-based exercise (iHBE) program is a 12-week program with 1 assessment home visit session, 2 home visits on the first and last week of the program and 10 weekly phone follow up. Participants were asked to choose their methods of exercise and set up weekly goals for exercise with the researcher. The technologies, a wearable device, and a smartphone application were used as a tool to monitor physical performance (heart rate \[HR\], step count), provide immediate feedback, and send daily reminding messages through Mobile Ecological Momentary Assessment (mEMA). The physical performance and goals were reviewed and adjusted by both participant and researcher weekly.	Usual Care (Control Group) n=12 Participants Participants were required to wear physical activity tracker (Fitbit) and respond to the daily symptoms survey (mEMA) while receiving usual care
Change in Physical Well Being	14.48 score on a scale Standard Deviation 26.48	-2.83 score on a scale Standard Deviation 17.67

PRIMARY outcome

Timeframe: Pre- and post-intervention, up to 12 weeks

Mental well-being was assessed using the 36-Item Short Form Health Survey (SF-36). The Mental Component Score was calculated as the average of relevant domains (vitality, social functioning, role limitations due to emotional health, and mental health). Each domain is scored from 0 to 100, and the average domain score was used to represent overall mental well-being. Higher scores indicate better mental health. The reported outcome is the mean change in the averaged raw score from baseline to completion. Positive values indicate an improvement in mental well-being.

Outcome measures

Outcome measures
Measure	The iHBE Program Group n=22 Participants Tailored Technology-Enhance Home-based exercise program (iHBE): The tailored technology-enhanced home-based exercise (iHBE) program is a 12-week program with 1 assessment home visit session, 2 home visits on the first and last week of the program and 10 weekly phone follow up. Participants were asked to choose their methods of exercise and set up weekly goals for exercise with the researcher. The technologies, a wearable device, and a smartphone application were used as a tool to monitor physical performance (heart rate \[HR\], step count), provide immediate feedback, and send daily reminding messages through Mobile Ecological Momentary Assessment (mEMA). The physical performance and goals were reviewed and adjusted by both participant and researcher weekly.	Usual Care (Control Group) n=12 Participants Participants were required to wear physical activity tracker (Fitbit) and respond to the daily symptoms survey (mEMA) while receiving usual care
Change in Mental Well Being	2.51 score on a scale Standard Deviation 6.29	0.16 score on a scale Standard Deviation 16.21

SECONDARY outcome

Timeframe: 12 weeks

The physical activity will be measured in a form of average step count/day measured by a wrist-worn wearable device.

Outcome measures

Outcome measures
Measure	The iHBE Program Group n=22 Participants Tailored Technology-Enhance Home-based exercise program (iHBE): The tailored technology-enhanced home-based exercise (iHBE) program is a 12-week program with 1 assessment home visit session, 2 home visits on the first and last week of the program and 10 weekly phone follow up. Participants were asked to choose their methods of exercise and set up weekly goals for exercise with the researcher. The technologies, a wearable device, and a smartphone application were used as a tool to monitor physical performance (heart rate \[HR\], step count), provide immediate feedback, and send daily reminding messages through Mobile Ecological Momentary Assessment (mEMA). The physical performance and goals were reviewed and adjusted by both participant and researcher weekly.	Usual Care (Control Group) n=12 Participants Participants were required to wear physical activity tracker (Fitbit) and respond to the daily symptoms survey (mEMA) while receiving usual care
Physical Activity	1279.11 steps/day Standard Deviation 2986.71	805.46 steps/day Standard Deviation 1682.42

SECONDARY outcome

Timeframe: Pre-and post-intervention, up to 12 weeks

Population: Due to the pandemic interruption with in-person research activity, we were unable to collect blood and sweat samples from the participants. Therefore, no data is available for this outcome.

The level of Brain-Derived Neurotrophic Factor in serum was measured by ELISA. The level will be measured in nanograms/milliliter.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre- and post-intervention, up to 12 weeks

Brain-Derived Neurotrophic Factor level in sweat collected through the sweat pad. The level will be measured in nanograms/milliliter.

Outcome measures

Outcome data not reported

Adverse Events

The iHBE Program Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care (Control Group)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nada Lukkahatai

Johns Hopkins School of Nursing

Phone: 2407509867

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place