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Trial record 9 of 4738 for:    British | Canada

Exercise Post Bone Marrow Transplant (ExP-BMT)

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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
Sponsor:
Collaborator:
British Columbia Cancer Agency
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:
This study is a preliminary study to assess whether it is possible to introduce an exercise program for BMT patients after discharge from hospital. The exercise program will include 3 endurance (stationary bike, walking) and 2 resistance (weights, stretch bands) training sessions/week, until 100 days after BMT. Our second plan is to test changes in QoL, aerobic fitness, muscle strength, total body fat and mineral composition, and blood immune markers with exercise in the 100 days after BMT. The investigators anticipate this study will improve the QoL, mobility, and strength of patients after BMT, therefore allowing a faster and healthier recovery.

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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Quality of Life [ Time Frame: Approximately 12-weeks ]
    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults ≥ 18 years of age
  • Undergoing alloHSCT for any indication through the LBMT Program of BC at VGH
  • Good comprehension of English (must be able to fill out questionnaires in English)

Exclusion Criteria:

  • Contraindications to entrance into an exercise program (i.e., known cardiovascular disease, musculoskeletal issue or not cleared for exercise by the attending physician)
  • Mobility impairment requiring use of mobility aids

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): NCT02320942


Contacts
Contact: Raewyn Broady 604-875-4952 RBroady@bccancer.bc.ca

Locations
Canada, British Columbia
Vancouver General Hospital - Krall Centre Centennial Pavilion 6 Recruiting
Vancouver, British Columbia, Canada, V5Z1M9
Contact: Raewyn Broady, MBChB    604-875-5320    rbroady@interchange.ubc.ca   
Sponsors and Collaborators
University of British Columbia
British Columbia Cancer Agency
Investigators
Principal Investigator: Raewyn Broady, MBChB British Columbia Cancer Agency

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02320942     History of Changes
Other Study ID Numbers: H14-01679
First Posted: December 19, 2014    Key Record Dates
Last Update Posted: August 26, 2015
Last Verified: August 2015

Keywords provided by University of British Columbia:
Bone Marrow Transplantation
Exercise
Rehabilitation
Cancer