Clinical trial · Interventional
Telehealth Based Intervention to Improve Functional Capacity in Survivors of Childhood Cancer With Significantly Limited Exercise Tolerance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
| Mobility Limitation | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise testing results | Other | — | UNRESOLVED |
| Generalized exercise recommendations (AC) | Other | — | UNRESOLVED |
| Individually tailored exercise program (INT) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Personalized exercise group (INTGroup)
- description
- Participants in this group have individually tailored exercise program with supervision, 20 weeks,clinic 3 times during the course of this study: at baseline (this appointment), at 4 months and 10 months from now for follow-up.
- interventionNames
- Other: Exercise testing results
- Other: Individually tailored exercise program (INT)
- type
- OTHER
- label
- Generalized exercise group, Attention Control (AC Group)
- description
- Study participants in this group receive generalized exercise recommendations, 20 weeks,clinic 3 times during the course of this study: at baseline (this appointment), at 4 months and 10 months from now for follow-up.
- interventionNames
- Other: Exercise testing results
- Other: Generalized exercise recommendations (AC)
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 39 Years
Show eligibility criteria text
Inclusion Criteria: * Between 18.00 and 39.99 years of age at the time of enrollment * SJLIFE participant * Peak VO2 \<85% predicted * Verbalizes understanding of directions for use of ZOOM on the study provided iPad and heart rate monitor * Clearance for participation in exercise by a study physician * Internet access Exclusion Criteria: * Enrolled in a formal exercise intervention * Self-report of engaging in \> 150 minutes/week of moderate physical activity * Currently pregnant (assess by urine pregnancy test) * Significant psychological distress (e.g. suicidal ideation) * Requires immediate medical intervention (e.g. angina, decompensated heart failure) * Research Participant Recruitment and Screening
References
Publications (1)
- DERIVEDMaharaj A, Jefferies JL, Mulrooney DA, Armstrong GT, Brinkman TM, O'Neil ST, Terrell S, Partin RE, Srivastava DK, Hudson MM, Wang Z, Ness KK. Design and methods of a randomized telehealth-based intervention to improve fitness in survivors of childhood cancer with exercise intolerance. Contemp Clin Trials. 2023 Oct;133:107339. doi: 10.1016/j.cct.2023.107339. Epub 2023 Sep 18. PMID 37730199