Multiphasic Prehab Allo-HSCT

Sponsor

University of Calgary (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05649371

Collaborator

Alberta Cancer Foundation (Other)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Other: Prehabilitation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Hybrid implementation-effectiveness studyHybrid implementation-effectiveness study

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prehabilitation	Other: Prehabilitation A multiphasic exercise prehabilitation program for alloHSCT candidates across each treatment phase, that includes behaviour change support

Arm

Intervention/Treatment

Experimental: Prehabilitation

Other: Prehabilitation

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

Outcome Measures

Primary Outcome Measures

Feasibility of Implementing an Exercise Program for Patients Undergoing Allogeneic-HSCT, Measured by Participant Attendance [6-9 months]
Review participant attendance/participation in the program and the questionnaires.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Calgary
Alberta Cancer Foundation

Investigators

Study Director: Nicole Culos-Reed, PhD, Health and Wellness Lab and the Thrive Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Calgary

ClinicalTrials.gov Identifier:

NCT05649371

Other Study ID Numbers:

ACE-HSCT

First Posted:

Dec 14, 2022

Last Update Posted:

Dec 14, 2022

Last Verified:

Oct 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Calgary

Prehabilitation

Exercise

Allogeneic Stem Cell Transplant

Study Results

No Results Posted as of Dec 14, 2022