Clinical trial NCT03874754: Tailored Home-Based Exercise Program for Multiple Chronic Conditions
Official title: Assessment of a Tailored Home-Based Exercise Program on Symptoms, Well-Being, and Resilience Among Cancer Survivors With Multiple Chronic Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Hypertension
Diabetes
Keywords: Multiple chronic conditions
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2019-03-14
Enrollment: 34
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a two-arm parallel assignment involving two groups of participants. One group receives exercise intervention, and the other group receives usual care (control group).
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Fatigue as Assessed by Self-reported Fatigue Questionnaire
timeFrame: Pre- and post-intervention, up to 12 weeks
measure: Change in Resilience as Assessed by Connor-Davidson Resilience Scale
timeFrame: Pre- and post-intervention, up to 12 weeks
measure: Change in Physical Well Being
timeFrame: Pre- and post-intervention, up to 12 weeks
measure: Change in Mental Well Being
timeFrame: Pre- and post-intervention, up to 12 weeks
Secondary outcomes:
measure: Physical Activity
timeFrame: 12 weeks
measure: Change in Brain-Derived Neurotrophic Factor Level (in Serum)
timeFrame: Pre-and post-intervention, up to 12 weeks
measure: Change in Brain-Derived Neurotrophic Factor Level (in Sweat)
timeFrame: Pre- and post-intervention, up to 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Sidney Kimmel Comprehensive Cancer Center
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Nursing
name: Nada Lukkahatai, PhD
role: PRINCIPAL_INVESTIGATOR
References: