Allogeneic Stem Cell TransplantationNCT02273024
Exercise Prior to Allogeneic Hematologic Stem Cell Transplantation
A study testing Exercise in people with Allogeneic Stem Cell Transplantation, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The investigators hypothesize that inactivity during the search for a donor may exacerbate current deconditioned states; subsequently, influencing risk factors for post-transplant complications that hinder the recovery phase. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Allogeneic Stem Cell Transplantation
- 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
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Aug 2019
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Medical indication: allogeneic stem cell transplantation at Princess Margaret Hospital
- must be ambulatory without need for human assistance at time of recruitment
- medically cleared to exercise by the transplant physician
- demonstrates willingness to attend supervised sessions
- sufficient in English to ensure safety of understanding prescribed exercise guidelines, or has access to an adequate non-familial interpreter
Who cannot join
- another active malignancy
- less than 4 weeks till the scheduled HSCT
- refusal to be randomized
- does not have the approval of their transplant physician
- severe or unstable neurological, cardiorespiratory, musculoskeletal disease or mental illness
Trial locations and contacts
1 site in 1 country.
Canada1 site
Princess Margaret Hospital & Toronto Rehabilitation Institute
Toronto, Ontario, M5T2M9
About this study
Official title: Exercise Therapy for Patients Awaiting Allogeneic Hematological Stem Cell Transplantation
The investigators hypothesize that inactivity during the search for a donor may exacerbate current deconditioned states; subsequently, influencing risk factors for post-transplant complications that hinder the recovery phase.
This study is designed to investigate if exercise therapy administered prior to allogeneic hematologic stem cell transplantation (HSCT) can influence physical and psychological side-effects associated with HSCT. Approximately 6-weeks prior to HSCT, individuals will be randomized into either an exercise group or usual care group and followed until one year after HSCT.
- Conditions
- Allogeneic Stem Cell Transplantation
- Being tested
- Exercise
- Keywords
- Exercise, Quality of Life, Fatigue, Symptoms, Prehabilitation, Aerobic Capacity
- Medical subject headings
- Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Individuals will participate in weekly supervised and unsupervised exercise sessions prior to HSCT, during hospitalization and till 100 days from HSCT. Exercise will consist of endurance and resistance exercise 3-5 days a week. Receives: Behavioral: Exercise |
| Usual Care | No intervention | Usual care will have continue with standard of care treatment without any specific exercise instruction or guidance other than what is provided by the patient education team at the cancer centre. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Function
Cardiopulmonary Capacity (VO2peak)
Measured: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Secondary outcomes (8)
Change in Quality of Life
European Organization for Research and Treatment of Cancer (EORTC) core 30-item questionnaire (QLQ-30)
Measured: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Change in Symptoms
Memorial Symptom Assessment Scale (MSAS)
Measured: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Change in Anxiety
The Generalized Anxiety Disorder (GAD7)
Measured: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Change in Depression
The Patient Health Questionnaire (PHQ-9), will be used as a clinically relevant measure to evaluate depression
Measured: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Change in Fatigue
Multidimensional Fatigue Inventory
Measured: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Change in Treatment Side-effects
Hospitalization (days till discharge and readmission rates), bone marrow engraftment (days), graft versus host disease incidence (acute \& chronic), severity of diarrhea/ vomiting/ nausea, infections, steroid use, blood counts
Measured: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Change in Strength
upper body: grip strength; lower body: chair-stand test
Measured: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Change in Six-minute walk test
Measured: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada, Toronto Rehabilitation Institute
- Responsible party
- Sponsor
- Investigators
- Jeff Lipton, MD, PhD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273024
- Sponsor's protocol ID
- 14-7699
- Status last verified
- Nov 2019
- First submitted
- 16 Oct 2014
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Therapy for Patients Awaiting Allogeneic Hematological Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02273024
- Acronym / sponsor ID
- 14-7699
- Conditions
- Allogeneic Stem Cell Transplantation
- Keywords
- Exercise, Quality of Life, Fatigue, Symptoms, Prehabilitation, Aerobic Capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada, Toronto Rehabilitation Institute
- Study start
- Oct 2014
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 23 Oct 2014 (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.
The investigators hypothesize that inactivity during the search for a donor may exacerbate current deconditioned states; subsequently, influencing risk factors for post-transplant complications that hinder the recovery phase.
This study is designed to investigate if exercise therapy administered prior to allogeneic hematologic stem cell transplantation (HSCT) can influence physical and psychological side-effects associated with HSCT. Approximately 6-weeks prior to HSCT, individuals will be randomized into either an exercise group or usual care group and followed until one year after HSCT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseIndividuals will participate in weekly supervised and unsupervised exercise sessions prior to HSCT, during hospitalization and till 100 days from HSCT. Exercise will consist of endurance and resistance exercise 3-5 days a week. |
| Usual Care | No intervention | –Usual care will have continue with standard of care treatment without any specific exercise instruction or guidance other than what is provided by the patient education team at the cancer centre. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Medical indication: allogeneic stem cell transplantation at Princess Margaret Hospital
- must be ambulatory without need for human assistance at time of recruitment
- medically cleared to exercise by the transplant physician
- demonstrates willingness to attend supervised sessions
- sufficient in English to ensure safety of understanding prescribed exercise guidelines, or has access to an adequate non-familial interpreter
Key exclusion criteria (5 listed)
- another active malignancy
- less than 4 weeks till the scheduled HSCT
- refusal to be randomized
- does not have the approval of their transplant physician
- severe or unstable neurological, cardiorespiratory, musculoskeletal disease or mental illness
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 |
|---|---|---|
| Exercise | Behavioural | Exercise |
Primary outcome
Change in Physical Function
Time frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Cardiopulmonary Capacity (VO2peak)
8 secondary outcomes
Change in Quality of Life
Time frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Change in Symptoms
Time frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Change in Anxiety
Time frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Change in Depression
Time frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Change in Fatigue
Time frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Change in Treatment Side-effects
Time frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Change in Strength
Time frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Change in Six-minute walk test
Time frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
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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.
Jeff Lipton, MD, PhD principal investigator
Princess Margaret Hospital, Canada
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 Allogeneic Stem Cell Transplantation, run by University Health Network, Toronto 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 25 Nov 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Function (time frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT). 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 25 Nov 2019.