A Multiphasic Prehabilitation Exercise Program For Allogeneic Hematopoietic Stem Cell Transplant Recipients

University of Calgary0 sites60 target enrollmentJanuary 2023

ConditionsLeukemia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Leukemia
Sponsor: University of Calgary
Enrollment: 60
Primary Endpoint: Feasibility of Implementing an Exercise Program for Patients Undergoing Allogeneic-HSCT, Measured by Participant Attendance
Status: Not Yet Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to implement a prehabilitation intervention to enhance recovery for people undergoing allogeneic stem cell transplant for hematologic malignancies. All participants in this study will receive a prehabilation intervention in addition to usual care (no change to their chemotherapy protocols or transplant) and several quality of life and fitness scores will be measured throughout the intervention.

Registry

clinicaltrials.gov

Start Date

January 2023

End Date

December 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Calgary

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult patients, 18 years or older, undergoing an allo-HSCT for acute leukemia.
•Approval to engage in exercise as per screening by the CSEP or ACSM certified CEP and/or clinician
•Ability to provide written informed consent and understand study information.

Exclusion Criteria

•Less than 18 years old
•Diagnosed with acute leukemia but not undergoing work-up for allo-HSCT
•Unable to read/communicate in English (i.e., unable to complete experimental procedures such as patient-reported outcomes).
•Neurological or musculoskeletal comorbidity inhibiting exercise.
•Diagnosed psychotic, addictive, or major cognitive disorders.
•Severe coronary artery disease (Canadian Cardiovascular Society class III or greater).
•Significant congestive heart failure (New York Heart Association class III or greater).
•Severe thrombocytopenia (platelets \<10) - ok if transfused platelets prior to exercise.

Outcomes

Primary Outcomes

Feasibility of Implementing an Exercise Program for Patients Undergoing Allogeneic-HSCT, Measured by Participant Attendance

Time Frame: 6-9 months

Review participant attendance/participation in the program and the questionnaires.

Secondary Outcomes

Amount of Physical Activity Measured With Activity Tracker(6-9 months)
Exercise Behaviour Measured with Modified Godin Leisure Time Exercise Questionnaire(6-9 months)
Patient Quality of Life Measured with the Functional Assessment of Cancer Therapy-Bone Marrow Transplant and EuroQol 5 Dimension 5 Level Questionnaire(6-9 months)
Level of Fatigue Measured with the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) Questionnaire(6-9 months)
Amount of Anxiety and depression Measured with the Hospital Anxiety and Depression Scale (HADS) Questionnaire(6-9 months)
Amount of Symptom burden Measured with the Edmonton Symptom Assessment System-revised (ESAS-r) Questionnaire(6-9 months)
Patient's Performance Status Measured by the Eastern Cooperative Oncology Group (ECOG) Scale(6-9 months)
Handgrip Strength Measured by Handgrip Dynamometry(6-9 months)
Balance Measured by Single Leg Stance Test(6-9 months)
Lower Limb Muscular Endurance Measured with 30-second sit-to-stand Test(6-9 months)