Multiphasic Prehab Allo-HSCT

NCT ID: NCT05649371

Last Updated: 2022-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2024-12-31

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.

Detailed Description

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Conditions

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Leukemia

Keywords

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Prehabilitation Exercise Allogeneic Stem Cell Transplant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Hybrid implementation-effectiveness study
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Prehabilitation

Group Type EXPERIMENTAL

Prehabilitation

Intervention Type OTHER

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

Interventions

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Prehabilitation

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

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alberta Cancer Foundation

OTHER

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicole Culos-Reed, PhD

Role: STUDY_DIRECTOR

Health and Wellness Lab and the Thrive Centre

Central Contacts

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Sarah Perry, MD, MSc

Role: CONTACT

Phone: 403 944 9602

Email: [email protected]

Chad Wagoner, PhD

Role: CONTACT

Phone: 403-210-8482

Email: [email protected]

Other Identifiers

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ACE-HSCT

Identifier Type: -

Identifier Source: org_study_id