Exercise Prior to Allogeneic Hematologic Stem Cell Transplantation

Study Overview
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Brief Summary
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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.

Official Title
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Exercise Therapy for Patients Awaiting Allogeneic Hematological Stem Cell Transplantation

Conditions
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Allogeneic Stem Cell Transplantation

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>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. | Behavioral: Exercise<br> <br> |
| No Intervention: Usual Care<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physical Function | Cardiopulmonary Capacity (VO2peak) | Baseline, 1 week pre HSCT, T100, 1yr post HSCT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life | European Organization for Research and Treatment of Cancer (EORTC) core 30-item questionnaire (QLQ-30) | Baseline, 1 week pre HSCT, T100, 1yr post HSCT | 
| Change in Symptoms | Memorial Symptom Assessment Scale (MSAS) | Baseline, 1 week pre HSCT, T100, 1yr post HSCT | 
| Change in Anxiety | The Generalized Anxiety Disorder (GAD7) | 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 | Baseline, 1 week pre HSCT, T100, 1yr post HSCT | 
| Change in Fatigue | Multidimensional Fatigue Inventory | 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 | Baseline, 1 week pre HSCT, T100, 1yr post HSCT | 
| Change in Strength | upper body: grip strength; lower body: chair-stand test | Baseline, 1 week pre HSCT, T100, 1yr post HSCT | 
| Change in Six-minute walk test |  | Baseline, 1 week pre HSCT, T100, 1yr post HSCT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Quality of Life, Fatigue, Symptoms, Prehabilitation, Aerobic Capacity