Hematological MalignancyEx-BMTNCT02900768
Effects of Exercise on Allogeneic Stem Cell Transplant
A study testing Exercise in people with Hematological Malignancy, run by Raewyn Broady at 1 site in Canada.
Trial summary
Although allogeneic haematopoietic stem cell transplant (AlloHSCT) is a curative treatment option for malignant hematological diseases, it is also associated with significant morbidity such as graft versus host disease, infections, and immune complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Malignancy
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2016to Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing allogeneic stem cell transplantation (including related, unrelated, cord blood or haploidentical allogeneic transplant) for any indication through the Leukemia/BMT Program of British Columbia.
- Age greater than or equal to 18 years.
- Able to provide written informed consent.
Who cannot join
- Severe cardiac disease including symptomatic congestive heart failure (New York Heart Association Class III or IV), unstable angina pectoris, or an unstable cardiac arrhythmia.
- Orthopedic illness which limits ability to conduct aerobic exercise (walking or biking).
- Not meeting eligibility criteria to proceed with allogeneic stem cell transplantation as per the Leukemia/BMT Program of BC.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vancouver General Hospital
Vancouver, British Columbia, V5Z1M9
Alina Gerrie, MD, 604-875-4863, agerrie@bccancer.bc.ca
About this study
Official title: Evaluating Effects on Quality of Life of a Partially Supervised Exercise Program Following Allogeneic Stem Cell Transplantation
Although allogeneic haematopoietic stem cell transplant (AlloHSCT) is a curative treatment option for malignant hematological diseases, it is also associated with significant morbidity such as graft versus host disease, infections, and immune complications. Moreover, long-term survivors are likely to have reduced physical performance and functioning due to deconditioning, sarcopenia, and bone loss, and particularly high levels of fatigue and psycho-social stress, all of which negatively impact patients' quality of life.
Purpose: To conduct a randomized controlled, single site trial investigating whether a partially supervised exercise intervention in the first 100 days post alloHSCT patients will result in improved quality of life at Day 100 post-transplant compared to standard of care treatment. Secondary objectives will investigate the effect of an exercise intervention on muscle strength, cardiorespiratory fitness, mobility, bone mineral density, body composition, exercise, and immunological/inflammatory biomarkers compared to standard of care.
Procedure: 120 patients receiving alloHSCT will be baseline tested, and then randomized into an Exercise Intervention Group or Standard of Care Control Group.
Read the detailed description
This is a randomized non-blinded single centre prospective clinical trial designed to evaluate the efficacy and safety of a partially-supervised progressive exercise intervention among patients undergoing alloHSCT compared to a self-directed exercise program. Approximately 120 patients will be enrolled. Following completion of all baseline data collection, participants will be randomized 1:1 to the intervention group or the control group.
Patients in the intervention group will receive an exercise manual with background information, descriptions for different resistance and aerobic exercises, and instructions for tailoring the intensity of exercise. All patients will receive Therabands™ for resistance exercises and have access to a stationary bicycle for aerobic exercises with practical introduction by an exercise specialist. The partially supervised intervention is a progressive program with a goal of three aerobic and two resistance exercise sessions per week.
Aerobic exercise will consist of 10-30 minutes of bicycling using a stationary bike (supervised or unsupervised) or brisk walking, following the Borg Scale of Rate of Perceived Exertion (RPE). Resistance exercise will include exercise for the upper and lower extremities with Therabands™. Exercise will be adapted based on the participant's clinical status for safety and ability to perform exercises. At the weekly supervised session, the exercise specialist will provide adequate progression of exercises, and review adherence to the intervention and provide support for questions and overcoming identified barriers to adherence.
Participants assigned to the control group will receive our current standard of care. They will be reviewed by the ward physiotherapist on admission to hospital and encouraged to maintain physical activity by walking around the inpatient unit during their inpatient hospitalization. As per standard of care, the physiotherapist will be available on an as needed basis in both the inpatient and outpatient settings.
Timely assessments of outcome measures outlined in the "Outcome Measures" section will be conducted for both groups.
- Conditions
- Hematological Malignancy
- Being tested
- Exercise
- Keywords
- Bone Marrow Transplantation, Exercise, Rehabilitation, Cancer
- Medical subject headings
- Hematologic Neoplasms, Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Combination of resistance and aerobic exercises for 100 days.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Patients in the intervention group will receive supervised and unsupervised exercise program after their bone marrow transplant. Receives: Behavioral: Exercise |
| Control Group | No intervention | Patient will receive standard of care within the hospital as an inpatient and outpatient after their bone marrow transplant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire.
To investigate if a partially supervised exercise intervention in alloHSCT patients will result in differences in quality of life at Day 100 post transplant compared to the standard of care control group.
Measured: Baseline, Day 100 post-transplant
Secondary outcomes (12)
Changes in Quality of Life
EuroQol (EQ)-5 Dimensions (5D) -3 Level (3L) Questionnaire.
Measured: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
Changes in Grip Strength
Using a handheld dynamometer, measured in kg.
Measured: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
Changes in 30-Second Chair Stand
Number of chair stands one can perform in 30 seconds.
Measured: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
Changes in 6-Minute Walk Test
Distance (meters) someone can walk in 6 minutes between two cones separated by 30 meters.
Measured: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
Changes in Timed Up and Go
Time taken for someone to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit sound.
Measured: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
Changes in Exercise Capacity
Exercise Treadmill Test via Bruce or Modified Bruce Protocol. METs and estimated peak oxygen uptake (VO2) will be determined.
Measured: Baseline, Day 100, 365, and 730 post-transplant
Changes in Cardiopulmonary Function
Left ventricular ejection fraction vs radionuclide ventriculography (MUGA) or echocardiography.
Measured: Baseline, Day 100, 365, and 730 post-transplant
Changes in Physical Activity Levels - Accelerometry
Accelerometry counts converted minutes/week of moderate-to-vigorous activity and sedentary activity and METS. Godin Leisure-Time Exercise Questionnaire.
Measured: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
Changes in Physical Activity Levels - Questionnaire
Godin Leisure-Time Exercise Questionnaire. Total leisure activity score is calculated.
Measured: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
Changes in Body Composition Analysis
Height (cm), weight (m), and waist/hip circumference (cm) will be measured.
Measured: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
Changes in Bone Mineral Density Analysis
Bone mineral density testing will be performed using a Dual-Energy X-Ray Absorptiometry (DXA).
Measured: Baseline, Day 100, 365, and 730 post transplant
Changes in Immune Biomarkers
A collective blood test will be done to determine the composition of white blood cells (total, lymphocytes, and subsets of T-Lymphocytes).
Measured: Baseline, Day 100, 365, and 730 post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignancyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Raewyn Broady
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Raewyn Broady, University of British Columbia
- Investigators
- Alina Gerrie, MD, FRCPC, Principal investigator, British Columbia Cancer AgencyRaewyn Broady, MBChB, FRCPC, Principal investigator, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900768
- Sponsor's protocol ID
- H16-00112
- Acronym
- Ex-BMT
- Status last verified
- Sep 2016
- First submitted
- 14 Aug 2016
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Effects on Quality of Life of a Partially Supervised Exercise Program Following Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02900768
- Acronym / sponsor ID
- Ex-BMT / H16-00112
- Conditions
- Hematological Malignancy
- Keywords
- Bone Marrow Transplantation, Exercise, Rehabilitation, Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Raewyn BroadyUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 14 Sep 2016 (estimated)
- 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.
Although allogeneic haematopoietic stem cell transplant (AlloHSCT) is a curative treatment option for malignant hematological diseases, it is also associated with significant morbidity such as graft versus host disease, infections, and immune complications. Moreover, long-term survivors are likely to have reduced physical performance and functioning due to deconditioning, sarcopenia, and bone loss, and particularly high levels of fatigue and psycho-social stress, all of which negatively impact patients' quality of life.
Purpose: To conduct a randomized controlled, single site trial investigating whether a partially supervised exercise intervention in the first 100 days post alloHSCT patients will result in improved quality of life at Day 100 post-transplant compared to standard of care treatment. Secondary objectives will investigate the effect of an exercise intervention on muscle strength, cardiorespiratory fitness, mobility, bone mineral density, body composition, exercise, and immunological/inflammatory biomarkers compared to standard of care.
Procedure: 120 patients receiving alloHSCT will be baseline tested, and then randomized into an Exercise Intervention Group or Standard of Care Control Group.
Detailed description
This is a randomized non-blinded single centre prospective clinical trial designed to evaluate the efficacy and safety of a partially-supervised progressive exercise intervention among patients undergoing alloHSCT compared to a self-directed exercise program. Approximately 120 patients will be enrolled. Following completion of all baseline data collection, participants will be randomized 1:1 to the intervention group or the control group.
Patients in the intervention group will receive an exercise manual with background information, descriptions for different resistance and aerobic exercises, and instructions for tailoring the intensity of exercise. All patients will receive Therabands™ for resistance exercises and have access to a stationary bicycle for aerobic exercises with practical introduction by an exercise specialist. The partially supervised intervention is a progressive program with a goal of three aerobic and two resistance exercise sessions per week.
Aerobic exercise will consist of 10-30 minutes of bicycling using a stationary bike (supervised or unsupervised) or brisk walking, following the Borg Scale of Rate of Perceived Exertion (RPE). Resistance exercise will include exercise for the upper and lower extremities with Therabands™. Exercise will be adapted based on the participant's clinical status for safety and ability to perform exercises. At the weekly supervised session, the exercise specialist will provide adequate progression of exercises, and review adherence to the intervention and provide support for questions and overcoming identified barriers to adherence.
Participants assigned to the control group will receive our current standard of care. They will be reviewed by the ward physiotherapist on admission to hospital and encouraged to maintain physical activity by walking around the inpatient unit during their inpatient hospitalization. As per standard of care, the physiotherapist will be available on an as needed basis in both the inpatient and outpatient settings.
Timely assessments of outcome measures outlined in the "Outcome Measures" section will be conducted for both groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Behavioral: ExercisePatients in the intervention group will receive supervised and unsupervised exercise program after their bone marrow transplant. |
| Control Group | No intervention | –Patient will receive standard of care within the hospital as an inpatient and outpatient after their bone marrow transplant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing allogeneic stem cell transplantation (including related, unrelated, cord blood or haploidentical allogeneic transplant) for any indication through the Leukemia/BMT Program of British Columbia.
- Age greater than or equal to 18 years.
- Able to provide written informed consent.
Key exclusion criteria (3 listed)
- Severe cardiac disease including symptomatic congestive heart failure (New York Heart Association Class III or IV), unstable angina pectoris, or an unstable cardiac arrhythmia.
- Orthopedic illness which limits ability to conduct aerobic exercise (walking or biking).
- Not meeting eligibility criteria to proceed with allogeneic stem cell transplantation as per the Leukemia/BMT Program of BC.
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 |
|---|---|---|
| ExerciseCombination of resistance and aerobic exercises for 100 days. | Behavioural | Exercise Group |
Primary outcome
Change in Quality of Life
Time frame: Baseline, Day 100 post-transplant
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. To investigate if a partially supervised exercise intervention in alloHSCT patients will result in differences in quality of life at Day 100 post transplant compared to the standard of care control group.
12 secondary outcomes
Changes in Quality of Life
Time frame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
Changes in Grip Strength
Time frame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
Changes in 30-Second Chair Stand
Time frame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
Changes in 6-Minute Walk Test
Time frame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
Changes in Timed Up and Go
Time frame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
Changes in Exercise Capacity
Time frame: Baseline, Day 100, 365, and 730 post-transplant
Changes in Cardiopulmonary Function
Time frame: Baseline, Day 100, 365, and 730 post-transplant
Changes in Physical Activity Levels - Accelerometry
Time frame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
Changes in Physical Activity Levels - Questionnaire
Time frame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
Changes in Body Composition Analysis
Time frame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
Changes in Bone Mineral Density Analysis
Time frame: Baseline, Day 100, 365, and 730 post transplant
Changes in Immune Biomarkers
Time frame: Baseline, Day 100, 365, and 730 post-transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
- Individual participant dataSharing planned: Undecided
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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.
Alina Gerrie, MD, FRCPC principal investigator
British Columbia Cancer Agency
Raewyn Broady, MBChB, FRCPC principal investigator
British Columbia Cancer Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Hematological Malignancy, run by Raewyn Broady at 1 site in Canada.
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 3 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 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Stanley Hung, MSc (604-827-1914, stanley.hung@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life (time frame: Baseline, Day 100 post-transplant). 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 Sep 2016.