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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
120
Combination of resistance and aerobic exercises for 100 days.
Vancouver General Hospital
Vancouver, British Columbia, Canada
Change in Quality of Life
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.
Time frame: Baseline, Day 100 post-transplant
Changes in Quality of Life
EuroQol (EQ)-5 Dimensions (5D) -3 Level (3L) Questionnaire.
Time frame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
Changes in Grip Strength
Using a handheld dynamometer, measured in kg.
Time frame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
Changes in 30-Second Chair Stand
Number of chair stands one can perform in 30 seconds.
Time frame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
Changes in 6-Minute Walk Test
Distance (meters) someone can walk in 6 minutes between two cones separated by 30 meters.
Time frame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
Changes in Timed Up and Go
Time taken for someone to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit sound.
Time frame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
Changes in Exercise Capacity
Exercise Treadmill Test via Bruce or Modified Bruce Protocol. METs and estimated peak oxygen uptake (VO2) will be determined.
Time frame: Baseline, Day 100, 365, and 730 post-transplant
Changes in Cardiopulmonary Function
Left ventricular ejection fraction vs radionuclide ventriculography (MUGA) or echocardiography.
Time frame: Baseline, Day 100, 365, and 730 post-transplant
Changes in Physical Activity Levels - Accelerometry
Accelerometry counts converted minutes/week of moderate-to-vigorous activity and sedentary activity and METS. Godin Leisure-Time Exercise Questionnaire.
Time frame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
Changes in Physical Activity Levels - Questionnaire
Godin Leisure-Time Exercise Questionnaire. Total leisure activity score is calculated.
Time frame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
Changes in Body Composition Analysis
Height (cm), weight (m), and waist/hip circumference (cm) will be measured.
Time frame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
Changes in Bone Mineral Density Analysis
Bone mineral density testing will be performed using a Dual-Energy X-Ray Absorptiometry (DXA).
Time frame: Baseline, Day 100, 365, and 730 post transplant
Changes in Immune Biomarkers
A collective blood test will be done to determine the composition of white blood cells (total, lymphocytes, and subsets of T-Lymphocytes).
Time frame: Baseline, Day 100, 365, and 730 post-transplant
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