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Multiphasic Prehab Allo-HSCT

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05649371
Enrollment
60
Registered
2022-12-14
Start date
2023-01-31
Completion date
2024-12-31
Last updated
2022-12-14

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

Conditions

Leukemia

Keywords

Prehabilitation, Exercise, Allogeneic Stem Cell Transplant

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.

Interventions

OTHERPrehabilitation

A multiphasic exercise prehabilitation program for alloHSCT candidates across each treatment phase, that includes behaviour change support

Sponsors

Alberta Cancer Foundation
CollaboratorOTHER
University of Calgary
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Hybrid implementation-effectiveness study

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of Implementing an Exercise Program for Patients Undergoing Allogeneic-HSCT, Measured by Participant Attendance6-9 monthsReview participant attendance/participation in the program and the questionnaires.

Secondary

MeasureTime frameDescription
Exercise Behaviour Measured with Modified Godin Leisure Time Exercise Questionnaire6-9 monthsSelf reported measure of physical activity. Higher scores are better.
Patient Quality of Life Measured with the Functional Assessment of Cancer Therapy-Bone Marrow Transplant and EuroQol 5 Dimension 5 Level Questionnaire6-9 monthsSelf reported physical, emotional and functional well-being.
Level of Fatigue Measured with the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) Questionnaire6-9 monthsSelf reported level of fatigue during daily activities. Lower scores mean less fatigue.
Amount of Anxiety and depression Measured with the Hospital Anxiety and Depression Scale (HADS) Questionnaire6-9 monthsSelf reported level of anxiety and depression. Higher scores indicate more anxiety and depression.
Amount of Physical Activity Measured With Activity Tracker6-9 monthsQuantity of physical activity, measured in hours.
Patient's Performance Status Measured by the Eastern Cooperative Oncology Group (ECOG) Scale6-9 monthsObjective score of patient's level of functioning. Lower scores indicate better functioning.
Handgrip Strength Measured by Handgrip Dynamometry6-9 monthsMaximum isometric strength of the hand and forearm muscles.
Balance Measured by Single Leg Stance Test6-9 monthsStatic postural and balance control, measured in seconds.
Lower Limb Muscular Endurance Measured with 30-second sit-to-stand Test6-9 monthsTests leg strength and endurance, measured in number of stands in 30 seconds.
Amount of Symptom burden Measured with the Edmonton Symptom Assessment System-revised (ESAS-r) Questionnaire6-9 monthsSelf reported symptoms. Higher scores indicate more symptoms.

Contacts

Primary ContactSarah Perry, MD, MSc
sarah.perry2@ahs.ca403 944 9602
Backup ContactChad Wagoner, PhD
chad.wagoner@ucalgary.ca403-210-8482

Outcome results

None listed

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