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Feasibility and Safety of Functional Performance Testing in Patients Undergoing Hematopoietic Cell Transplantation

Feasibility and Safety of Functional Performance Testing in Patients Undergoing Hematopoietic Cell Transplantation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02598752
Enrollment
11
Registered
2015-11-06
Start date
2015-11-30
Completion date
2020-04-10
Last updated
2020-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia, Hematological Malignancy, Leukemia, Lymphoma, Myelodysplastic Syndrome, Myeloma

Keywords

functional performance testing, exercise fitness testing, 15-274

Brief summary

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.

Interventions

OTHERSymptom-limited cardiopulmonary exercise test (CPET)
OTHERResting assessment of cardiac function by echocardiography
OTHERPost-exercise assessment of cardiac function by echocardiography
OTHERPulmonary function
BEHAVIORALPatient-reported outcomes questionnaire

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
VO2peak1 yearis a measure determined by the CPET

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026