Tailored Home-Based Exercise Program for Multiple Chronic Conditions (iHBE)
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|ClinicalTrials.gov Identifier: NCT03874754|
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : December 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cancer Hypertension Diabetes||Other: Tailored Technology-Enhance Home-based exercise program (iHBE)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The data collectors are blinded to the group allocation|
|Primary Purpose:||Supportive Care|
|Official Title:||Assessment of a Tailored Home-Based Exercise Program on Symptoms, Well-Being, and Resilience Among Cancer Survivors With Multiple Chronic Conditions|
|Actual Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||March 31, 2022|
Experimental: The iHBE program group
an intervention group
Other: Tailored Technology-Enhance Home-based exercise program (iHBE)
The tailored technology enhanced home-based exercise (iHBE) program is a 4-week program with 1 assessment home visit session, 4 home visits during exercise. The detail activities are presented in table 1. The technologies, a wearable device, and a smartphone application, will be used as a tool to monitor physical performance (heart rate [HR], step count), provide immediate feedback, send daily reminding message through Mobile Ecological Momentary Assessment (mEMA). The coded raw data without personal identification information from the wearable device will be sent to the servers where the investigators can store it in the database alongside the mEMA data and create custom reports showing Heart Rate (HR) 30 minute before each Ecological Momentary Assessment (EMA) survey, showing HR and previous self-report responses before/ after each automatically triggered EMA.
Other Name: iHBE
No Intervention: Usual Care (Control group)
A control group
- Change in Fatigue as assessed by self-reported fatigue questionnaire [ Time Frame: Pre- and post-intervention, up to 4 weeks ]6-items; self-reported fatigue (frequency, duration, intensity) and the impact on physical, mental, and social activities, has five response options (1 or never to 5 or always). The overall score range from 6 (no fatigue) to 30 (extreme fatigue)
- Change in Resilience as assessed by Connor-Davidson Resilience scale [ Time Frame: Pre- and post-intervention, up to 4 weeks ]Connor-Davidson Resilience scale: 10 item self-report rating scale 0 (not true at all) to 4 (true nearly all the time). The overall score range from 0 (no resilience) to 40 (High Resilience).
- Change in Physical well being [ Time Frame: Pre- and post-intervention, up to 4 weeks ]Physical well being as assessed by 36 item self-report instrument. The overall score derived from the physical functioning, role limitation-physical, and bodily pain domains. The overall score range from 0-400, with a score 400 reflecting the highest rating of physical health.
- Change in Mental well being [ Time Frame: Pre- and post-intervention, up to 4 weeks ]Mental well being is measured by the 36 item self-report instrument. The overall score derived from the mental health, role limitation-emotional domains. The total score range from 0 to 200, with the score of 200 indicated high mental well being
- Physical activity [ Time Frame: 4 weeks ]The physical activity will be measured in a form of average step count/day and average active minutes/day measured by a wrist-worn wearable device.
- Change in Brain Derived Neurotrophic Factor level (in serum) [ Time Frame: Pre- and post-intervention, up to 4 weeks ]The level of Brain Derived Neurotrophic Factor in serum measured by ELISA. The level will be measured in nanograms/milliliter.
- Change in Brain Derived Neurotrophic Factor level (in sweat) [ Time Frame: Pre- and post-intervention, up to 4 weeks ]Brain Derived Neurotrophic Factor level in sweat collected through the sweat pad. The level will be measured in nanograms/milliliter.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03874754
|Contact: Nada Lukkahatai, PhDfirstname.lastname@example.org|
|United States, Maryland|
|The Sidney Kimmel Comprehensive Cancer Center||Recruiting|
|Baltimore, Maryland, United States, 21205|
|Contact: Nada Lukkahatai, PhD 240-750-9867 email@example.com|
|Principal Investigator:||Nada Lukkahatai, PhD||Johns Hopkins School of Nursing|