Clinical trial · Interventional
Yoga Fatigue Study
A Randomized Controlled Trial of Individualized Yoga to Reduce Fatigue in Hospitalized Children Receiving Intensive Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was closed early for poor accrual when 125/210 planned participants had been enrolled and randomized to yoga (n=62) or iPad (n=63).
Summary
Brief summary (as posted)
Fatigue is a major problem in children, adolescents and adults receiving intensive chemotherapy for cancer and in patients undergoing hematopoietic stem cell transplantation (HSCT). Guidelines from the National Comprehensive Cancer Network suggest that all patients, including children as young as 5 years of age, should be routinely screened for fatigue at the initial visit and at regular intervals throughout and following anti-cancer treatment. These guidelines also suggest that fatigue should be managed according to clinical practice guidelines. However, evidence demonstrating effective interventions for fatigue in children with cancer is scarce. Exercise is an effective intervention for cancer-related fatigue in patients of all ages. However, patients receiving the most intensive treatments may be too ill to participate in a standardized exercise program. A unique and potentially effective intervention that combines exercise and relaxation is yoga. This randomized controlled trial (RCT) will determine whether a 3 week program of individualized yoga is associated with less fatigue, better quality of life (QoL) and less systemic opioid use compared to the control program of an Apple tablet (iPad) games, music, movies or books. This is a multi-center, parallel-group, randomized trial of individualized yoga for fatigue. Subjects are inpatients 8-18 years of age receiving intensive chemotherapy for cancer or undergoing HSCT who are expected to remain in hospital for 3 weeks. Participants will be randomized to the individualized yoga program or to the iPad activity control program. For those who remain hospitalized on day 21, the alternate intervention will be offered for 1 week and the preferred strategy will be determined. Yoga has the potential to significantly reduce fatigue, a prevalent and distressing symptom, in children with cancer and HSCT. The investigators have assembled the optimal team with the expertise and track record to accomplish this important trial. This trial is an incremental and critically important step in a program of research designed to improve health for children at the highest risk for poor quality of life. Results may have broad applicability to other hospitalized pediatric populations and has the potential to change in-hospital care for these patients.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphocytic Leukemia in Relapse | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Burkitt's Lymphoma Stage III | Burkitt Lymphoma | CURATED_BROADER | 0.78 |
| Burkitt's Lymphoma Stage IV | Burkitt Lymphoma | CURATED_BROADER | 0.78 |
| Type 3 Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma Unclassifiable | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Individualized Yoga Intervention Group | Behavioral | — | UNRESOLVED |
| iPad Activity Control Group | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Individualized Yoga Intervention Group
- description
- Yoga will be administered individually by a trained yoga instructor, and offered daily for 21 days (5 days per week or 15 days in total). There will be a common structure for all sessions that will include relaxation and breathing exercises. Additional poses focused on strength, flexibility, and balance will be incorporated at low, moderate or high intensity levels based upon the wishes and abilities of the child and parent and the judgment of the yoga instructor. The target intensity will be documented and may change with each yoga session. Each yoga session will vary in duration between 15 and 45 minutes. Modifications will be made to accommodate devices such as central venous lines, particularly if accessed. For children who are in isolation, the research team will follow hospital policies and procedures.
- interventionNames
- Behavioral: Individualized Yoga Intervention Group
- type
- ACTIVE_COMPARATOR
- label
- iPad Activity Control Group
- description
- For those randomized to the control group, visits by the same yoga instructors will occur at the same schedule as the yoga intervention. Contact will be offered daily (5 days per week) for 21 days. The yoga instructor will offer games, music, movies or books on a study-supplied iPad. The instructor will offer to interact with the child (for example, read to, or play games with the child) for a maximum of 45 minutes (the maximum length of yoga sessions). This approach will allow us to control for contact frequency and the individual providing contact, and consequently, to better measure the independent effect of yoga. These children will not receive yoga during the 3 week iPad activity period; instructors will receive specific training to ensure that no yoga occurs during this time frame. Use of child or hospital supplied iPad activities will be permitted instead of the study-supplied iPad activities.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Child diagnosed with any AML, relapsed ALL, stage 3 or 4 Burkitt's or diffuse B large cell lymphoma/leukemia OR about to receive autologous or allogeneic HSCT for any indication * Child expected to be an inpatient for at least 3 weeks after initiation of chemotherapy or conditioning * Child aged 8 to 18 years at enrollment. Conditioning regimen may be myeloablative or reduced intensity Exclusion Criteria: * Following features present to an extent that would preclude compliance with yoga, as assessed by the attending physician: a) motor disability, b) cognitive disability, c) cardiopulmonary symptoms, or d) known compression fracture resulting in disability * Parent or patient cannot understand verbal English * For HSCT patients, planned non-myeloablative conditioning regimen.
References
Publications (1)
- DERIVEDSchechter T, Tardif-Theriault C, Culos-Reed N, Lewis V, Orsey A, Diorio C, Tomlinson GA, Sung L. Yoga versus iPad active control for fatigue in paediatric cancer therapy: a randomised controlled trial. BMJ Support Palliat Care. 2025 Feb 26;15(2):204-212. doi: 10.1136/spcare-2023-004609. PMID 38160047