Tailored Home-Based Exercise Program for Multiple Chronic Conditions

NCT03874754 | Completed Results DMC

• 3 other identifiers: J1886P30NR018093-01IRB00175781
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Hypertension; Diabetes

Keywords

Multiple chronic conditions

Outcome Measures

Primary Outcomes (4)

• Change in Fatigue as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0-Fatigue 6a

  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.

  Pre- and post-intervention, up to 12 weeks

• Change in Resilience as Assessed by Connor-Davidson Resilience Scale

  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.

  Pre- and post-intervention, up to 12 weeks

• Change in Physical Well Being

  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.

  Pre- and post-intervention, up to 12 weeks

• Change in Mental Well Being

  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.

  Pre- and post-intervention, up to 12 weeks

Secondary Outcomes (3)

• Physical Activity

  12 weeks

• Change in Brain-Derived Neurotrophic Factor Level (in Serum)

  Pre-and post-intervention, up to 12 weeks

• Change in Brain-Derived Neurotrophic Factor Level (in Sweat)

  Pre- and post-intervention, up to 12 weeks

Study Arms (2)

The iHBE program group

EXPERIMENTAL

Tailored Technology-Enhance Home-based exercise program (iHBE)

Other: Tailored Technology-Enhance Home-based exercise program (iHBE)

Usual Care (Control group)

NO INTERVENTION

Participants were required to wear physical activity tracker (Fitbit) and respond to the daily symptoms survey (mEMA) while receiving usual care

Interventions

Tailored Technology-Enhance Home-based exercise program (iHBE) OTHER

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.

Also known as: iHBE

The iHBE program group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

The Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Neoplasms; Hypertension; Diabetes Mellitus; Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was interrupted by the COVID-19 pandemic, which led to unanticipated pauses in study activities and affected participant enrollment, intervention delivery, and follow-up assessments. As a result, the sample size was smaller than originally planned and some study procedures were modified. These factors may limit the generalizability of the findings and the ability to fully determine the intervention's effect.

Results Point of Contact

• Title: Nada Lukkahatai
• Organization: Johns Hopkins School of Nursing

nada.lukkahatai@jhu.edu

2407509867

Study Officials

• Nada Lukkahatai, PhD

  Johns Hopkins School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single blinded marking: The data collectors are blinded to the group allocation
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 14, 2019
• Study Start: August 1, 2019
• Primary Completion: January 31, 2021
• Study Completion: June 30, 2021
• Last Updated: October 14, 2025
• Results First Posted: September 21, 2022

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)