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

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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hematological Malignancy	Behavioral: Exercise	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Evaluating Effects on Quality of Life of a Partially Supervised Exercise Program Following Allogeneic Stem Cell Transplantation
• Study Start Date: September 2016
• Estimated Primary Completion Date: December 2020
• Estimated Study Completion Date: December 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Exercise Group; Patients in the intervention group will receive supervised and unsupervised exercise program after their bone marrow transplant.	Behavioral: Exercise; Combination of resistance and aerobic exercises for 100 days.
No Intervention: Control Group; Patient will receive standard of care within the hospital as an inpatient and outpatient after their bone marrow transplant.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. Changes in Cardiopulmonary Function [ Time Frame: Baseline, Day 100, 365, and 730 post-transplant ]
   Left ventricular ejection fraction vs radionuclide ventriculography (MUGA) or echocardiography.
8. 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.
9. 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.
10. 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.
11. 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).
12. 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).

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Stanley Hung, MSc; 604-827-1914; stanley.hung@ubc.ca

Locations

Canada, British Columbia

Vancouver General Hospital; Not yet recruiting

Vancouver, British Columbia, Canada, V5Z1M9

Contact: Alina Gerrie, MD 604-875-4863 agerrie@bccancer.bc.ca

Sponsors and Collaborators

Raewyn Broady

Investigators

• Principal Investigator: Alina Gerrie, MD, FRCPC; British Columbia Cancer Agency
• Principal Investigator: Raewyn Broady, MBChB, FRCPC; British Columbia Cancer Agency

More Information

• Responsible Party: Raewyn Broady, Clinical Associate Professor, University of British Columbia
• ClinicalTrials.gov Identifier: NCT02900768 History of Changes
• Other Study ID Numbers: H16-00112
• First Posted: September 14, 2016
• Last Update Posted: September 14, 2016
• Last Verified: September 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Raewyn Broady, University of British Columbia:

Bone Marrow Transplantation; Exercise; Rehabilitation; Cancer

Additional relevant MeSH terms:

Neoplasms