Telehealth Based Intervention to Improve Functional Capacity in Survivors

Status Recruiting

Clinical Trial Summary

The participants are asked to take part in this clinical trial, a type of research study. The participants are SJLIFE study participants and may have a hard time exercising (exercise intolerance) due to side effects of cancer treatment received as a child.This study is being done to determine if a personalized exercise plan will help childhood cancer survivors who have exercise intolerance become more active. Primary Objectives: To achieve the goal of this study, we propose the following three Objectives: Primary Objective 1: To determine the efficacy of an individually tailored, home-delivered aerobic and strengthening intervention to improve exercise capacity in survivors of childhood cancer with exercise intolerance (peak oxygen uptake (peak VO2) <85% of age and sex predicted). Primary Objective 2: To determine the effects of an individually tailored, home-delivered aerobic and strengthening intervention on measures of cardiac, pulmonary, musculoskeletal, and neurosensory function in survivors of childhood cancer with exercise intolerance. Primary Objective 3: To determine the effects of an individually tailored, home-delivered aerobic and strengthening intervention on emotional health, participation in family and community activities, quality of life, and cognitive function in survivors of childhood cancer with exercise intolerance.

Clinical Trial Description

The design for this study will be a single-blind two-arm, prospective, randomized clinical trial. Performance testing results: Both groups of participants will be provided with the results of their performance testing. Individually tailored exercise program: Individuals randomized to receive an individually tailored exercise program will meet with an exercise specialist.Generalized exercise recommendations: Individuals randomized to receive the generalized exercise recommendations will receive a copy of the Physical Activity Guidelines for Americans. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04714840
Study type	Interventional
Source	St. Jude Children's Research Hospital
Contact	Kirsten Ness, PhD
Phone	866-278-5833
Email	referralinfo@stjude.org
Status	Recruiting
Phase	N/A
Start date	February 8, 2021
Completion date	December 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Telehealth Based Intervention to Improve Functional Capacity in Survivors of Childhood Cancer With Significantly Limited Exercise Tolerance

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms