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Exercise Prior to Allogeneic Hematologic Stem Cell Transplantation

Exercise Therapy for Patients Awaiting Allogeneic Hematological Stem Cell Transplantation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02273024
Enrollment
30
Registered
2014-10-23
Start date
2014-10-31
Completion date
2019-08-31
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allogeneic Stem Cell Transplantation

Keywords

Exercise, Quality of Life, Fatigue, Symptoms, Prehabilitation, Aerobic Capacity

Brief 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. 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.

Interventions

BEHAVIORALExercise

Sponsors

Princess Margaret Hospital, Canada
CollaboratorOTHER
Toronto Rehabilitation Institute
CollaboratorOTHER
University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Physical FunctionBaseline, 1 week pre HSCT, T100, 1yr post HSCTCardiopulmonary Capacity (VO2peak)

Secondary

MeasureTime frameDescription
Change in Quality of LifeBaseline, 1 week pre HSCT, T100, 1yr post HSCTEuropean Organization for Research and Treatment of Cancer (EORTC) core 30-item questionnaire (QLQ-30)
Change in SymptomsBaseline, 1 week pre HSCT, T100, 1yr post HSCTMemorial Symptom Assessment Scale (MSAS)
Change in AnxietyBaseline, 1 week pre HSCT, T100, 1yr post HSCTThe Generalized Anxiety Disorder (GAD7)
Change in DepressionBaseline, 1 week pre HSCT, T100, 1yr post HSCTThe Patient Health Questionnaire (PHQ-9), will be used as a clinically relevant measure to evaluate depression
Change in Treatment Side-effectsBaseline, 1 week pre HSCT, T100, 1yr post HSCTHospitalization (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
Change in StrengthBaseline, 1 week pre HSCT, T100, 1yr post HSCTupper body: grip strength; lower body: chair-stand test
Change in Six-minute walk testBaseline, 1 week pre HSCT, T100, 1yr post HSCT
Change in FatigueBaseline, 1 week pre HSCT, T100, 1yr post HSCTMultidimensional Fatigue Inventory

Other

MeasureTime frameDescription
Adherence to exercise sessionsOne yearFeasibility of an exercise intervention prior to HSCT till T100

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026