Clinical trial · Observational
Feasibility and Safety of Functional Performance Testing in Patients Undergoing Hematopoietic Cell Transplantation
NCT02598752CI-TRIAL-00044690completedClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to see if exercise fitness testing is feasible and safe in persons over 21 years of age who have been diagnosed with a hematological malignancy and are scheduled to undergo a hematopoietic stem cell transplant (HCT). Assessments in this study will look at the capacity of the body before transplantation to see if these measures can help predict how patients do after transplant.
Conditions
Conditions (6)
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 Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Hematological Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient-reported outcomes questionnaire | Behavioral | — | UNRESOLVED |
| Post-exercise assessment of cardiac function by echocardiography | Other | — | UNRESOLVED |
| Pulmonary function | Other | — | UNRESOLVED |
| Resting assessment of cardiac function by echocardiography | Other | — | UNRESOLVED |
| Symptom-limited cardiopulmonary exercise test (CPET) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- functional performance testing
- description
- This observational study will evaluate the feasibility and safety of functional performance testing in patients undergoing HCT. In addition to standard of care procedures, participants will undergo a CPET with a rest and stress echo, pulmonary function, and patient reported outcome questionnaires within 30 days of HCT.
- interventionNames
- Other: Symptom-limited cardiopulmonary exercise test (CPET)
- Other: Resting assessment of cardiac function by echocardiography
- Other: Post-exercise assessment of cardiac function by echocardiography
- Other: Pulmonary function
- Behavioral: Patient-reported outcomes questionnaire
Primary outcomes (1)
- measure
- VO2peak
- timeFrame
- 1 year
- description
- is a measure determined by the CPET
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with MSK histologically confirmed hematologic malignancy * Scheduled for autologous or allogenic HCT at MSKCC * ≥21 years old * ECOG performance status of 0 or 1 * Completion of baseline CPET * Willing to comply with protocol related procedures Exclusion Criteria: * Any of the following absolute contraindications to cardiopulmonary exercise testing * Acute myocardial Infarction (within 3-5 days of any planned study procedures) * Unstable angina * Uncontrolled arrhythmia causing symptoms or hemodynamic compromise * Recurrent syncope * Active endocarditis * Acute myocarditis or pericarditis * Symptomatic severe aortic stenosis * Uncontrolled heart failure * Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures * Thrombosis of lower extremities * Suspected dissecting aneurysm * Uncontrolled asthma * Pulmonary edema * Respiratory failure * Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis) * Presence of any other concurrent, actively treated malignancy; * History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer); * Room air desaturation at rest ≤85% * Mental impairment leading to inability to cooperate
References
Publications (0)
Data not yet available
No reference posted for this study.