Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors, TECHS Trial

Hodgkin Lymphoma Clinical Trial

Official title:

Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors (TECHS): A Pilot Feasibility Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05205512
• Other study ID #: 21595
• Secondary ID: NCI-2021-1330521
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 14, 2022
• Est. completion date: October 29, 2024

Study information

• Verified date: January 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVE: I. Determine the feasibility of an 8-week telehealth exercise intervention, as assessed by enrollment, retention, and adherence to the telehealth exercise intervention. SECONDARY OBJECTIVE: I. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: October 29, 2024
• Est. primary completion date: October 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hodgkin Lymphoma
• Lymphoma
• Non-Hodgkin Lymphoma

Intervention

Other:
• Exercise Intervention
Maintain current levels of physical activity
• Questionnaire Administration
Ancillary studies
• Telemedicine
Participate in telehealth exercise intervention

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to the telehealth exercise intervention	Adherence will be measured by the number of exercise sessions attended over the exercise sessions prescribed (17/24 sessions).	Up to 2 years
Secondary	Effects of an 8-week telehealth exercise intervention	The physiologic effects of telehealth exercise intervention will be assessed by peak oxygen consumption (VO2) using cardiopulmonary exercise testing.	At baseline up to week 9