Tailored Home-Based Exercise Program for Multiple Chronic Conditions (iHBE)

Assessment of a Tailored Home-Based Exercise Program on Symptoms, Well-Being, and Resilience Among Cancer Survivors With Multiple Chronic Conditions

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Diabetes; Cancer
• Intervention / Treatment: Other: Tailored Technology-Enhance Home-based exercise program (iHBE)

Detailed Description

The benefits of physical activity on managing chronic illnesses and multiple symptoms are well established. However, increasing the physical activity of persons living with Multiple Chronic Conditions (MCC), especially low -income cancer survivors with MCC, is challenging. Home-based exercise improves physical activity and symptoms among persons with the single chronic disease. One major challenge of the home-based exercise is the motivation and adherence. The mobile technologies (e.g., wearable device and smartphone application) have been used to improve motivation and monitor a person physical activity. Guided by the society to cells framework and previous preliminary findings, the investigators developed a technology-enhanced home-based exercise program using a combination of the integrated mobile technologies (wearable device and phone application) and tailored home-based exercise. Participants will choose one of the four home-based exercise options [National Institute of Aging (NIA) Go4Life, 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 and trigger algorithms to send the survey and notification to the participants in real time. This pilot project will examine the feasibility of this technology-enhanced home exercise tailored to participants' goals and preferences. The intervention will leverage the cancer survivorship phase (post-treatment) to motivate self-care by combining tailored existing evidence-based physical activity programs and mobile technology for participants to engage in the resilience-enhancing physical activity. Identification of BDNF's role as one of the exercise outcomes provide a novel target for an intervention and increase the investigators' understanding of the underlying mechanism of symptoms and resilience. This study aims to examine the feasibility and acceptability of the iHBE program among low-income cancer survivors living with co-morbid conditions. Eight participants who have completed treatment for a solid tumor cancer with at least one comorbidity (e.g., diabetes and/or hypertension) will be assigned to an open-label trial of the idea. The investigators will gather feedback on goal setting, problem-solving strategies, exercise choices, and tracking mechanisms, program feasibility, and acceptability and modify the intervention as needed.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • The Sidney Kimmel Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• participants diagnosed with solid tumor cancer who have completed cancer treatment at least 6 months;
• diagnosed with diabetes and/or hypertension for at least a year;
• aged 21 years or older,
• have an annual household incomes of below $50,000 for families of three,
• the average fatigue level within the past 7 days at the level of 3 or more on the 0 (no fatigue) to 10 (worse fatigue) Likert scale
• give informed consent.

Exclusion Criteria:

• currently undergoing treatment for cancer;
• have an active infection (e.g., fever, localized redness, swelling, sinus congestion);
• diagnosed with a psychological disorder (e.g., suicidal or homicidal tendencies, extreme anxiety or depression)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The iHBE program group; Tailored Technology-Enhance Home-based exercise program (iHBE)	Other: 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, 5 home visits and 7 phone follow ups during exercise. 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 Names: iHBE
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fatigue as Assessed by Self-reported Fatigue Questionnaire	Patient-Reported Outcomes Measures Information System (PROMIS) Short Form V1.0-Fatigue 6a. A 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). Higher score means a greater fatigue	Pre- and post-intervention, up to 12 weeks
Change in Resilience as Assessed by Connor-Davidson Resilience Scale	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). The higher score means a better resilience	Pre- and post-intervention, up to 12 weeks
Change in Physical Well Being	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.	Pre- and post-intervention, up to 12 weeks
Change in Mental Well Being	Mental component of the Short Form Survey (SF-36), the 36 item self-report instrument. The overall score was derived from the mental health, and role limitation-emotional domains. The total score range from 0 to 200, with a score of 200 indicating high mental well being	Pre- and post-intervention, up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity	The physical activity will be measured in a form of average step count/day measured by a wrist-worn wearable device.	12 weeks
Change in Brain-Derived Neurotrophic Factor Level (in Serum)	The level of Brain-Derived Neurotrophic Factor in serum was measured by ELISA. The level will be measured in nanograms/milliliter.	Pre-and post-intervention, up to 12 weeks
Change in Brain-Derived Neurotrophic Factor Level (in Sweat)	Brain-Derived Neurotrophic Factor level in sweat collected through the sweat pad. The level will be measured in nanograms/milliliter.	Pre- and post-intervention, up to 12 weeks

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: National Institute of Nursing Research (NINR)

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Multiple chronic conditions
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease; Multiple Chronic Conditions
• Other Study ID Numbers: J1886; P30NR018093-01 (U.S. NIH Grant/Contract); IRB00175781 (Other Identifier: JHM IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data (IPD) will not be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No