Clinical trial NCT05649371: Multiphasic Prehab Allo-HSCT
Official title: A Multiphasic Prehabilitation Exercise Program For Allogeneic Hematopoietic Stem Cell Transplant Recipients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Leukemia
Keywords: Prehabilitation
Exercise
Allogeneic Stem Cell Transplant
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Cancer Foundation
First posted: 2022-12-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Hybrid implementation-effectiveness study
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Feasibility of Implementing an Exercise Program for Patients Undergoing Allogeneic-HSCT, Measured by Participant Attendance
timeFrame: 6-9 months
Secondary outcomes:
measure: Amount of Physical Activity Measured With Activity Tracker
timeFrame: 6-9 months
measure: Exercise Behaviour Measured with Modified Godin Leisure Time Exercise Questionnaire
timeFrame: 6-9 months
measure: Patient Quality of Life Measured with the Functional Assessment of Cancer Therapy-Bone Marrow Transplant and EuroQol 5 Dimension 5 Level Questionnaire
timeFrame: 6-9 months
measure: Level of Fatigue Measured with the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) Questionnaire
timeFrame: 6-9 months
measure: Amount of Anxiety and depression Measured with the Hospital Anxiety and Depression Scale (HADS) Questionnaire
timeFrame: 6-9 months
measure: Amount of Symptom burden Measured with the Edmonton Symptom Assessment System-revised (ESAS-r) Questionnaire
timeFrame: 6-9 months
measure: Patient's Performance Status Measured by the Eastern Cooperative Oncology Group (ECOG) Scale
timeFrame: 6-9 months
measure: Handgrip Strength Measured by Handgrip Dynamometry
timeFrame: 6-9 months
measure: Balance Measured by Single Leg Stance Test
timeFrame: 6-9 months
measure: Lower Limb Muscular Endurance Measured with 30-second sit-to-stand Test
timeFrame: 6-9 months
Other outcomes:
Locations:
Study officials:
affiliation: Health and Wellness Lab and the Thrive Centre
name: Nicole Culos-Reed, PhD
role: STUDY_DIRECTOR
References: