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Exercise Prior to Allogeneic Hematologic Stem Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02273024
Recruitment Status : Completed
First Posted : October 23, 2014
Last Update Posted : November 25, 2019
Sponsor:
Collaborators:
Princess Margaret Hospital, Canada
Toronto Rehabilitation Institute
Information provided by (Responsible Party):
University Health Network, Toronto

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.


Condition or disease Intervention/treatment Phase
Allogeneic Stem Cell Transplantation Behavioral: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise
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
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.



Primary Outcome Measures :
  1. Change in Physical Function [ Time Frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT ]
    Cardiopulmonary Capacity (VO2peak)


Secondary Outcome Measures :
  1. 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)

  2. Change in Symptoms [ Time Frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT ]
    Memorial Symptom Assessment Scale (MSAS)

  3. Change in Anxiety [ Time Frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT ]
    The Generalized Anxiety Disorder (GAD7)

  4. 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

  5. Change in Fatigue [ Time Frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT ]
    Multidimensional Fatigue Inventory

  6. 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

  7. Change in Strength [ Time Frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT ]
    upper body: grip strength; lower body: chair-stand test

  8. Change in Six-minute walk test [ Time Frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT ]

Other Outcome Measures:
  1. Adherence to exercise sessions [ Time Frame: One year ]
    Feasibility of an exercise intervention prior to HSCT till T100



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
Princess Margaret Hospital & Toronto Rehabilitation Institute
Toronto, Ontario, Canada, M5T2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Toronto Rehabilitation Institute
Investigators
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Principal Investigator: Jeff Lipton, MD, PhD Princess Margaret Hospital, University Health Network

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02273024    
Other Study ID Numbers: 14-7699
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019
Keywords provided by University Health Network, Toronto:
Exercise
Quality of Life
Fatigue
Symptoms
Prehabilitation
Aerobic Capacity