Exercise Post Bone Marrow Transplant (ExP-BMT)
|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: NCT02320942|
Recruitment Status : Unknown
Verified August 2015 by University of British Columbia.
Recruitment status was: Recruiting
First Posted : December 19, 2014
Last Update Posted : August 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Other: Exercise Intervention||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Implementation of a Physician-prescribed Exercise Program as Standard of Care in Allogeneic Stem Cell Transplant Patients in British Columbia: a Pilot Study.|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
Experimental: Exercise Intervention
At discharge from the inpatient unit, participants will receive a practical introduction by an exercise specialist and enrolled in the 12-week exercise intervention
Other: Exercise Intervention
The semi-supervised intervention is a progressive program with a goal of three aerobic and two resistance exercise sessions per week. Aerobic exercise will consist of 20-40 minutes of bicycling using a stationary bike located on CP6 (supervised or un-supervised) or brisk walking at home. Resistance exercise will include exercise for the upper and lower extremities with stretch bands. Patients will complete at least one supervised aerobic and resistance session per week with the exercise trainer and complete a daily log of their exercise, including adherence, adverse events and symptoms.
- Quality of Life [ Time Frame: Approximately 12-weeks ]European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
- Baseline Demographics [ Time Frame: Baseline: pre-BMT visit. ]Demographic data will be collected by patient interviews at baseline, including age, other health conditions and physical activity levels prior to HSCT. Medical and transplantation variables will be obtained from patients' medical records.
- Aerobic Fitness [ Time Frame: Approximately 12-weeks ]Aerobic fitness will be assessed using the 6 minute walk test (6MWT) protocol by the American Thoracic Society. This test has been used extensively in clinical exercise trials to estimate aerobic capacity and has been tested in the HSCT population.
- Muscle Strength [ Time Frame: Approximately 12-weeks ]Muscle strength will be evaluated by the 30-second chair stand (lower extremity), which is a component of the Senior's Fitness test, and grip strength (upper extremity). Mobility will be measured by the time-up-and go test.
- Body Composition [ Time Frame: Approximately 12-weeks ]Standing height, body weight, and waist and hip circumferences will be measured. Baseline bone mineral density testing (BMD), 1,25-OH vitamin D and calcium levels, and dual-energy X-ray absorptiometry (DXA) scan are performed by Dr. Kendler, pre-transplant and at day +100 as standard of care. The DXA scan is a well validated tool which accurately and precisely measures lean, fat, and mineral composition and has a number of strengths compared to other modalities of body composition measurement.
- Immune Function [ Time Frame: Approximately 12-weeks ]Markers of immune function including total white blood cell count, lymphocyte count, CD4+ and CD8+ subsets of T-lymphocytes, and T-regulatory cells will be tested pre-BMT and at Day 100. These markers have been previously evaluated in studies of exercise interventions in HSCT patients with inconsistent results.
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): NCT02320942
|Contact: Raewyn Broady||604-875-4952||RBroady@bccancer.bc.ca|
|Canada, British Columbia|
|Vancouver General Hospital - Krall Centre Centennial Pavilion 6||Recruiting|
|Vancouver, British Columbia, Canada, V5Z1M9|
|Contact: Raewyn Broady, MBChB 604-875-5320 email@example.com|
|Principal Investigator:||Raewyn Broady, MBChB||British Columbia Cancer Agency|