Clinical trial NCT02900768: Effects of Exercise on Allogeneic Stem Cell Transplant
Official title: Evaluating Effects on Quality of Life of a Partially Supervised Exercise Program Following Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hematological Malignancy
Keywords: Bone Marrow Transplantation
Exercise
Rehabilitation
Cancer
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Change in Quality of Life
timeFrame: Baseline, Day 100 post-transplant
Secondary outcomes:
measure: Changes in Quality of Life
timeFrame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
measure: Changes in Grip Strength
timeFrame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
measure: Changes in 30-Second Chair Stand
timeFrame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
measure: Changes in 6-Minute Walk Test
timeFrame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
measure: Changes in Timed Up and Go
timeFrame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
measure: Changes in Exercise Capacity
timeFrame: Baseline, Day 100, 365, and 730 post-transplant
measure: Changes in Cardiopulmonary Function
timeFrame: Baseline, Day 100, 365, and 730 post-transplant
measure: Changes in Physical Activity Levels - Accelerometry
timeFrame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
measure: Changes in Physical Activity Levels - Questionnaire
timeFrame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
measure: Changes in Body Composition Analysis
timeFrame: Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant
measure: Changes in Bone Mineral Density Analysis
timeFrame: Baseline, Day 100, 365, and 730 post transplant
measure: Changes in Immune Biomarkers
timeFrame: Baseline, Day 100, 365, and 730 post-transplant
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: British Columbia Cancer Agency
name: Alina Gerrie, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: British Columbia Cancer Agency
name: Raewyn Broady, MBChB, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: