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Effects of Exercise on Allogeneic Stem Cell Transplant (Ex-BMT)

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ClinicalTrials.gov Identifier: NCT02900768
Recruitment Status : Not yet recruiting
First Posted : September 14, 2016
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Raewyn Broady, University of British Columbia

Tracking Information
First Submitted Date  ICMJE August 14, 2016
First Posted Date  ICMJE September 14, 2016
Last Update Posted Date September 14, 2016
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2016)
Change in Quality of Life [ Time Frame: Baseline, Day 100 post-transplant ]
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. To investigate if a partially supervised exercise intervention in alloHSCT patients will result in differences in quality of life at Day 100 post transplant compared to the standard of care control group.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2016)
  • Changes in Quality of Life [ Time Frame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant ]
    EuroQol (EQ)-5 Dimensions (5D) -3 Level (3L) Questionnaire.
  • Changes in Grip Strength [ Time Frame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant ]
    Using a handheld dynamometer, measured in kg.
  • Changes in 30-Second Chair Stand [ Time Frame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant ]
    Number of chair stands one can perform in 30 seconds.
  • Changes in 6-Minute Walk Test [ Time Frame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant ]
    Distance (meters) someone can walk in 6 minutes between two cones separated by 30 meters.
  • Changes in Timed Up and Go [ Time Frame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant ]
    Time taken for someone to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit sound.
  • Changes in Exercise Capacity [ Time Frame: Baseline, Day 100, 365, and 730 post-transplant ]
    Exercise Treadmill Test via Bruce or Modified Bruce Protocol. METs and estimated peak oxygen uptake (VO2) will be determined.
  • Changes in Cardiopulmonary Function [ Time Frame: Baseline, Day 100, 365, and 730 post-transplant ]
    Left ventricular ejection fraction vs radionuclide ventriculography (MUGA) or echocardiography.
  • Changes in Physical Activity Levels - Accelerometry [ Time Frame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant ]
    Accelerometry counts converted minutes/week of moderate-to-vigorous activity and sedentary activity and METS. Godin Leisure-Time Exercise Questionnaire.
  • Changes in Physical Activity Levels - Questionnaire [ Time Frame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant ]
    Godin Leisure-Time Exercise Questionnaire. Total leisure activity score is calculated.
  • Changes in Body Composition Analysis [ Time Frame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant ]
    Height (cm), weight (m), and waist/hip circumference (cm) will be measured.
  • Changes in Bone Mineral Density Analysis [ Time Frame: Baseline, Day 100, 365, and 730 post transplant ]
    Bone mineral density testing will be performed using a Dual-Energy X-Ray Absorptiometry (DXA).
  • Changes in Immune Biomarkers [ Time Frame: Baseline, Day 100, 365, and 730 post-transplant ]
    A collective blood test will be done to determine the composition of white blood cells (total, lymphocytes, and subsets of T-Lymphocytes).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Exercise on Allogeneic Stem Cell Transplant
Official Title  ICMJE Evaluating Effects on Quality of Life of a Partially Supervised Exercise Program Following Allogeneic Stem Cell Transplantation
Brief Summary

Although allogeneic haematopoietic stem cell transplant (AlloHSCT) is a curative treatment option for malignant hematological diseases, it is also associated with significant morbidity such as graft versus host disease, infections, and immune complications. Moreover, long-term survivors are likely to have reduced physical performance and functioning due to deconditioning, sarcopenia, and bone loss, and particularly high levels of fatigue and psycho-social stress, all of which negatively impact patients' quality of life.

Purpose: To conduct a randomized controlled, single site trial investigating whether a partially supervised exercise intervention in the first 100 days post alloHSCT patients will result in improved quality of life at Day 100 post-transplant compared to standard of care treatment. Secondary objectives will investigate the effect of an exercise intervention on muscle strength, cardiorespiratory fitness, mobility, bone mineral density, body composition, exercise, and immunological/inflammatory biomarkers compared to standard of care.

Procedure: 120 patients receiving alloHSCT will be baseline tested, and then randomized into an Exercise Intervention Group or Standard of Care Control Group.

Detailed Description

This is a randomized non-blinded single centre prospective clinical trial designed to evaluate the efficacy and safety of a partially-supervised progressive exercise intervention among patients undergoing alloHSCT compared to a self-directed exercise program. Approximately 120 patients will be enrolled. Following completion of all baseline data collection, participants will be randomized 1:1 to the intervention group or the control group.

Patients in the intervention group will receive an exercise manual with background information, descriptions for different resistance and aerobic exercises, and instructions for tailoring the intensity of exercise. All patients will receive Therabands™ for resistance exercises and have access to a stationary bicycle for aerobic exercises with practical introduction by an exercise specialist. The partially supervised intervention is a progressive program with a goal of three aerobic and two resistance exercise sessions per week.

Aerobic exercise will consist of 10-30 minutes of bicycling using a stationary bike (supervised or unsupervised) or brisk walking, following the Borg Scale of Rate of Perceived Exertion (RPE). Resistance exercise will include exercise for the upper and lower extremities with Therabands™. Exercise will be adapted based on the participant's clinical status for safety and ability to perform exercises. At the weekly supervised session, the exercise specialist will provide adequate progression of exercises, and review adherence to the intervention and provide support for questions and overcoming identified barriers to adherence.

Participants assigned to the control group will receive our current standard of care. They will be reviewed by the ward physiotherapist on admission to hospital and encouraged to maintain physical activity by walking around the inpatient unit during their inpatient hospitalization. As per standard of care, the physiotherapist will be available on an as needed basis in both the inpatient and outpatient settings.

Timely assessments of outcome measures outlined in the "Outcome Measures" section will be conducted for both groups.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Hematological Malignancy
Intervention  ICMJE Behavioral: Exercise
Combination of resistance and aerobic exercises for 100 days.
Study Arms  ICMJE
  • Experimental: Exercise Group
    Patients in the intervention group will receive supervised and unsupervised exercise program after their bone marrow transplant.
    Intervention: Behavioral: Exercise
  • No Intervention: Control Group
    Patient will receive standard of care within the hospital as an inpatient and outpatient after their bone marrow transplant.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 9, 2016)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients undergoing allogeneic stem cell transplantation (including related, unrelated, cord blood or haploidentical allogeneic transplant) for any indication through the Leukemia/BMT Program of British Columbia.
  2. Age greater than or equal to 18 years.
  3. Able to provide written informed consent.

Exclusion Criteria:

  1. Severe cardiac disease including symptomatic congestive heart failure (New York Heart Association Class III or IV), unstable angina pectoris, or an unstable cardiac arrhythmia.
  2. Orthopedic illness which limits ability to conduct aerobic exercise (walking or biking).
  3. Not meeting eligibility criteria to proceed with allogeneic stem cell transplantation as per the Leukemia/BMT Program of BC.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stanley Hung, MSc 604-827-1914 stanley.hung@ubc.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02900768
Other Study ID Numbers  ICMJE H16-00112
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Raewyn Broady, University of British Columbia
Study Sponsor  ICMJE Raewyn Broady
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alina Gerrie, MD, FRCPC British Columbia Cancer Agency
Principal Investigator: Raewyn Broady, MBChB, FRCPC British Columbia Cancer Agency
PRS Account University of British Columbia
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP