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

Not Applicable

Active, not recruiting

• Conditions: Non-Hodgkin Lymphoma; Hodgkin Lymphoma
• Interventions: Other: Exercise Intervention; Other: Questionnaire Administration; Other: Telemedicine

• Registration Number: NCT05205512
• Lead Sponsor: City of Hope Medical Center

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-12-27
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-25
• Study Start: 2022-09-14
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-06-29
• Study Completion: 2025-06-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (delayed control)	Questionnaire Administration	Patients maintain current levels of physical activity for 8 weeks. Patients may then participate in telehealth exercise intervention for 8 weeks.
Group I (telehealth exercise)	Telemedicine	Patients participate in telehealth exercise intervention for 30 minutes per day, 3 days a week for 8 weeks.
Group II (delayed control)	Telemedicine	Patients maintain current levels of physical activity for 8 weeks. Patients may then participate in telehealth exercise intervention for 8 weeks.
Group I (telehealth exercise)	Questionnaire Administration	Patients participate in telehealth exercise intervention for 30 minutes per day, 3 days a week for 8 weeks.
Group II (delayed control)	Exercise Intervention	Patients maintain current levels of physical activity for 8 weeks. Patients may then participate in telehealth exercise intervention for 8 weeks.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States