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Clinical Trials/NCT05205512
NCT05205512
Completed
Not Applicable

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

City of Hope Medical Center1 site in 1 country10 target enrollmentSeptember 14, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hodgkin Lymphoma
Sponsor
City of Hope Medical Center
Enrollment
10
Locations
1
Primary Endpoint
Adherence to the telehealth exercise intervention
Status
Completed
Last Updated
6 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 14, 2022
End Date
June 9, 2025
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
City of Hope Medical Center
Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

Adherence to the telehealth exercise intervention

Time Frame: Up to 2 years

Adherence will be measured by the number of exercise sessions attended over the exercise sessions prescribed (17/24 sessions).

Secondary Outcomes

  • Effects of an 8-week telehealth exercise intervention(At baseline up to week 9)

Study Sites (1)

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