Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors, TECHS Trial
Study Details
Study Description
Brief Summary
This clinical trial tests how well a telehealth exercise intervention works to improve cardiovascular health in lymphoma survivors. Telehealth exercise is a service to help perform physical exercises at home with a care provider online. With the use of telehealth exercise lymphoma survivors may be able to participate in exercise programs safely to improve heart health and reduce the risk of cardiovascular disease.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVE:
- Determine the feasibility of an 8-week telehealth exercise intervention, as assessed by enrollment, retention, and adherence to the telehealth exercise intervention.
SECONDARY OBJECTIVE:
- Explore the effects of an 8-week telehealth exercise intervention on cardiovascular health, assessed by cardiopulmonary exercise test, pulmonary function test, body compositions, and blood biomarkers.
OUTLINE: Participants are randomized into 1 of 2 groups.
GROUP I (TELEHEALTH EXERCISE): Patients participate in telehealth exercise intervention for 30 minutes per day, 3 days a week for 8 weeks.
GROUP II (DELAYED CONTROL): Patients maintain current levels of physical activity for 8 weeks. Patients may then participate in telehealth exercise intervention for 8 weeks.
After completion of study treatment, participants are followed up after 1 week.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Group I (telehealth exercise) Patients participate in telehealth exercise intervention for 30 minutes per day, 3 days a week for 8 weeks. |
Other: Questionnaire Administration
Ancillary studies
Other: Telemedicine
Participate in telehealth exercise intervention
Other Names:
|
Active Comparator: Group II (delayed control) Patients maintain current levels of physical activity for 8 weeks. Patients may then participate in telehealth exercise intervention for 8 weeks. |
Other: Exercise Intervention
Maintain current levels of physical activity
Other: Questionnaire Administration
Ancillary studies
Other: Telemedicine
Participate in telehealth exercise intervention
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Adherence to the telehealth exercise intervention [Up to 2 years]
Adherence will be measured by the number of exercise sessions attended over the exercise sessions prescribed (17/24 sessions).
Secondary Outcome Measures
- Effects of an 8-week telehealth exercise intervention [At baseline up to week 9]
The physiologic effects of telehealth exercise intervention will be assessed by peak oxygen consumption (VO2) using cardiopulmonary exercise testing.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosed with Hodgkin or non-Hodgkin lymphoma.
-
= 18 years old.
-
Are between 2-5 years after completing anti-cancer therapy and with no evidence of disease.
-
Intermediate (4-5) to high ( >= 6) risk of cardiovascular risk factors based on six key variables: Age 30 to 50 years (y) [2]) and >= 50y [3]; anthracycline dose >250mg/m ^ 2 [1]; hypertension [2]; diabetes [2]; smoking [1]; and chest radiation [1]).
-
Able to understand and sign the informed consent document.
-
Physically able and willing to complete all study procedures.
Exclusion Criteria:
-
Have overt cardiovascular disease within 6 months (e.g. myocardial infarction, stroke, angina).
-
Have contraindications to exercise.
-
Participate in structured exercise (>60 minutes/week).
-
Female patients who are pregnant or planning to become pregnant.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | City of Hope Medical Center | Duarte | California | United States | 91010 |
Sponsors and Collaborators
- City of Hope Medical Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Kyuwan Lee, City of Hope Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21595
- NCI-2021-13305
- 21595
- P30CA033572