Multiphasic Prehab Allo-HSCT

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05649371
• Other study ID #: ACE-HSCT
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2022
• Source: University of Calgary
• Contact: Sarah Perry, MD, MSc
• Phone: 403 944 9602
• Email: sarah.perry2[@]ahs.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Alberta Cancer Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Amount of Physical Activity Measured With Activity Tracker	Quantity of physical activity, measured in hours.	6-9 months
Secondary	Exercise Behaviour Measured with Modified Godin Leisure Time Exercise Questionnaire	Self reported measure of physical activity. Higher scores are better.	6-9 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Handgrip Strength Measured by Handgrip Dynamometry	Maximum isometric strength of the hand and forearm muscles.	6-9 months
Secondary	Balance Measured by Single Leg Stance Test	Static postural and balance control, measured in seconds.	6-9 months
Secondary	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