Exercise Prior to Allogeneic Hematologic Stem Cell Transplantation
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|ClinicalTrials.gov Identifier: NCT02273024|
Recruitment Status : Completed
First Posted : October 23, 2014
Last Update Posted : November 25, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Allogeneic Stem Cell Transplantation||Behavioral: Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Exercise Therapy for Patients Awaiting Allogeneic Hematological Stem Cell Transplantation|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||August 2019|
|Actual Study Completion Date :||August 2019|
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.
No Intervention: Usual Care
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.
- Change in Physical Function [ Time Frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT ]Cardiopulmonary Capacity (VO2peak)
- Change in Quality of Life [ Time Frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT ]European Organization for Research and Treatment of Cancer (EORTC) core 30-item questionnaire (QLQ-30)
- Change in Symptoms [ Time Frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT ]Memorial Symptom Assessment Scale (MSAS)
- Change in Anxiety [ Time Frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT ]The Generalized Anxiety Disorder (GAD7)
- Change in Depression [ Time Frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT ]The Patient Health Questionnaire (PHQ-9), will be used as a clinically relevant measure to evaluate depression
- Change in Fatigue [ Time Frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT ]Multidimensional Fatigue Inventory
- Change in Treatment Side-effects [ Time Frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT ]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
- Change in Strength [ Time Frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT ]upper body: grip strength; lower body: chair-stand test
- Change in Six-minute walk test [ Time Frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT ]
- Adherence to exercise sessions [ Time Frame: One year ]Feasibility of an exercise intervention prior to HSCT till T100
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273024
|Princess Margaret Hospital & Toronto Rehabilitation Institute|
|Toronto, Ontario, Canada, M5T2M9|
|Principal Investigator:||Jeff Lipton, MD, PhD||Princess Margaret Hospital, University Health Network|