N/A
N=34
Tailored Home-Based Exercise Program for Multiple Chronic Conditions
Cancer · Hypertension · Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03874754 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Change in Fatigue as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0-Fatigue 6a — -1.61; 4.26 T-score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tailored Technology-Enhance Home-based exercise program (iHBE) (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Fatigue as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0-Fatigue 6a |
-1.61; 4.26 | — |
| PRIMARY Change in Resilience as Assessed by Connor-Davidson Resilience Scale |
0.00; 0.89 | — |
| PRIMARY Change in Physical Well Being |
14.48; -2.83 | — |
| PRIMARY Change in Mental Well Being |
2.51; 0.16 | — |
| SECONDARY Physical Activity |
1279.11; 805.46 | — |
| SECONDARY Change in Brain-Derived Neurotrophic Factor Level (in Serum) |
— | — |
| SECONDARY Change in Brain-Derived Neurotrophic Factor Level (in Sweat) |
— | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT03874754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.