LeukemiaNCT05649371
Multiphasic Prehab Allo-HSCT
A study testing Prehabilitation in people with Leukemia, run by University of Calgary.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Leukemia
- What is being tested?
- Prehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multiphasic Prehabilitation Exercise Program For Allogeneic Hematopoietic Stem Cell Transplant Recipients
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.
- Conditions
- Leukemia
- Being tested
- Prehabilitation
- Keywords
- Prehabilitation, Exercise, Allogeneic Stem Cell Transplant
- Medical subject headings
- Leukemia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationOther
A multiphasic exercise prehabilitation program for alloHSCT candidates across each treatment phase, that includes behaviour change support
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | Not described Receives: Other: Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-9 months
Secondary outcomes (10)
Amount of Physical Activity Measured With Activity Tracker
Quantity of physical activity, measured in hours.
Measured: 6-9 months
Exercise Behaviour Measured with Modified Godin Leisure Time Exercise Questionnaire
Self reported measure of physical activity. Higher scores are better.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6-9 months
Handgrip Strength Measured by Handgrip Dynamometry
Maximum isometric strength of the hand and forearm muscles.
Measured: 6-9 months
Balance Measured by Single Leg Stance Test
Static postural and balance control, measured in seconds.
Measured: 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.
Measured: 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study startJan 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Hybrid implementation-effectiveness study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Nicole Culos-Reed, PhD, Study director, Health and Wellness Lab and the Thrive Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649371
- Sponsor's protocol ID
- ACE-HSCT
- Status last verified
- Oct 2022
- First submitted
- 7 Nov 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiphasic Prehabilitation Exercise Program For Allogeneic Hematopoietic Stem Cell Transplant Recipients
- ClinicalTrials.gov ID
- NCT05649371
- Acronym / sponsor ID
- ACE-HSCT
- Conditions
- Leukemia
- Keywords
- Prehabilitation, Exercise, Allogeneic Stem Cell Transplant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Cancer Foundation
- Study start
- Jan 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Hybrid implementation-effectiveness study
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Other: Prehabilitation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrehabilitationA multiphasic exercise prehabilitation program for alloHSCT candidates across each treatment phase, that includes behaviour change support | Other | Prehabilitation |
Primary outcome
Feasibility of Implementing an Exercise Program for Patients Undergoing Allogeneic-HSCT, Measured by Participant Attendance
Time frame: 6-9 months
Review participant attendance/participation in the program and the questionnaires.
10 secondary outcomes
Amount of Physical Activity Measured With Activity Tracker
Time frame: 6-9 months
Exercise Behaviour Measured with Modified Godin Leisure Time Exercise Questionnaire
Time frame: 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
Time frame: 6-9 months
Level of Fatigue Measured with the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) Questionnaire
Time frame: 6-9 months
Amount of Anxiety and depression Measured with the Hospital Anxiety and Depression Scale (HADS) Questionnaire
Time frame: 6-9 months
Amount of Symptom burden Measured with the Edmonton Symptom Assessment System-revised (ESAS-r) Questionnaire
Time frame: 6-9 months
Patient's Performance Status Measured by the Eastern Cooperative Oncology Group (ECOG) Scale
Time frame: 6-9 months
Handgrip Strength Measured by Handgrip Dynamometry
Time frame: 6-9 months
Balance Measured by Single Leg Stance Test
Time frame: 6-9 months
Lower Limb Muscular Endurance Measured with 30-second sit-to-stand Test
Time frame: 6-9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Culos-Reed, PhD study director
Health and Wellness Lab and the Thrive Centre
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Leukemia, run by University of Calgary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Perry, MD, MSc (403 944 9602 ext. 3, sarah.perry2@ahs.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Implementing an Exercise Program for Patients Undergoing Allogeneic-HSCT, Measured by Participant Attendance (time frame: 6-9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.