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NCT03874754: iHBE

Tailored Home-Based Exercise Program for Multiple Chronic Conditions

Completed NA Results posted Last updated 14 October 2025
What this trial tests

NA trial testing Tailored Technology-Enhance Home-based exercise program (iHBE) in Cancer in 34 participants. Completed in 30 June 2021.

Timeline
1 August 2019
Primary endpoint
31 January 2021
30 June 2021

Quick facts

Lead sponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposesupportive care
Enrollment34
Start date1 August 2019
Primary completion31 January 2021
Estimated completion30 June 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →

Who can join

21 and older, any sex, with Cancer or Hypertension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Fatigue as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0-Fatigue 6a Primary · Pre- and post-intervention, up to 12 weeks

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.

GroupValue95% CI
The iHBE Program Group-1.61± 6.75
Usual Care (Control Group)4.26± 7.95
Change in Resilience as Assessed by Connor-Davidson Resilience Scale Primary · 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.

GroupValue95% CI
The iHBE Program Group0.00± 4.97
Usual Care (Control Group)0.89± 6.41
Change in Physical Well Being Primary · 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.

GroupValue95% CI
The iHBE Program Group14.48± 26.48
Usual Care (Control Group)-2.83± 17.67
Change in Mental Well Being Primary · 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.

GroupValue95% CI
The iHBE Program Group2.51± 6.29
Usual Care (Control Group)0.16± 16.21
Physical Activity Secondary · 12 weeks

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

GroupValue95% CI
The iHBE Program Group1279.11± 2986.71
Usual Care (Control Group)805.46± 1682.42

Sponsor's own description

A home-based, tailored, technology-enhanced home-based exercise program (iHBE) using a combination of the integrated mobile technologies (wearable device and phone application) and tailored home-based exercise will be pilot tested. Participants will choose one of the four home-based exercise options \[National Institute of Aging (NIA) Go4Life (an exercise and physical activity campaign from the NIA), Iyengar-style yoga, walking, and modified Otago exercise\] based on participants' preference and goals. The integrated mobile technologies system will allow the investigators to extract heart rate data directly from the wearable device to the research server. This data will be used to provide appropriate and personalized feedback on physical performance. The survey and notification to the participants on the smartphone.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Application of wearables for remote monitoring of oncology patients: A scoping review.
    Cloß K, Verket M, Müller-Wieland D, Marx N, et al · · 2024 · cited 16× · PMID 38481796 · DOI 10.1177/20552076241233998
  2. Integrating Artificial Intelligence-Driven Wearable Technology in Oncology Decision-Making: A Narrative Review.
    Birla M, Rajan, Roy PG, Gupta I, et al · · 2025 · cited 14× · PMID 39072365 · DOI 10.1159/000540494
  3. A Comparison of In-Person and Telehealth Personalized Exercise Programs for Cancer Survivors: A Secondary Data Analysis.
    Lukkahatai N, Han G, Benjasirisan C, Park J, et al · · 2025 · PMID 40805134 · DOI 10.3390/cancers17152432

Verify or expand the search:

Other recruiting trials for Cancer

Currently open trials in the same condition.

Other Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03874754.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing