Multiphasic Prehab Allo-HSCT

Study Overview
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Brief Summary
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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.

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

Conditions
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Leukemia

Intervention / Treatment
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* Other: Prehabilitation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Hybrid implementation-effectiveness study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehabilitation<br> | Other: Prehabilitation<br>* A multiphasic exercise prehabilitation program for alloHSCT candidates across each treatment phase, that includes behaviour change support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Implementing an Exercise Program for Patients Undergoing Allogeneic-HSCT, Measured by Participant Attendance | Review participant attendance/participation in the program and the questionnaires. | 6-9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Physical Activity Measured With Activity Tracker | Quantity of physical activity, measured in hours. | 6-9 months | 
| Exercise Behaviour Measured with Modified Godin Leisure Time Exercise Questionnaire | Self reported measure of physical activity. Higher scores are better. | 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 | Self reported physical, emotional and functional well-being. | 6-9 months | 
| Level of Fatigue Measured with the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) Questionnaire | Self reported level of fatigue during daily activities. Lower scores mean less fatigue. | 6-9 months | 
| Amount of Anxiety and depression Measured with the Hospital Anxiety and Depression Scale (HADS) Questionnaire | Self reported level of anxiety and depression. Higher scores indicate more anxiety and depression. | 6-9 months | 
| Amount of Symptom burden Measured with the Edmonton Symptom Assessment System-revised (ESAS-r) Questionnaire | Self reported symptoms. Higher scores indicate more symptoms. | 6-9 months | 
| Patient's Performance Status Measured by the Eastern Cooperative Oncology Group (ECOG) Scale | Objective score of patient's level of functioning. Lower scores indicate better functioning. | 6-9 months | 
| Handgrip Strength Measured by Handgrip Dynamometry | Maximum isometric strength of the hand and forearm muscles. | 6-9 months | 
| Balance Measured by Single Leg Stance Test | Static postural and balance control, measured in seconds. | 6-9 months | 
| Lower Limb Muscular Endurance Measured with 30-second sit-to-stand Test | Tests leg strength and endurance, measured in number of stands in 30 seconds. | 6-9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prehabilitation, Exercise, Allogeneic Stem Cell Transplant