Effects of Exercise on Allogeneic Stem Cell Transplant

Hematological Malignancy Clinical Trial

— Ex-BMT  

Official title:

Evaluating Effects on Quality of Life of a Partially Supervised Exercise Program Following Allogeneic Stem Cell Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02900768
• Other study ID #: H16-00112
• Status: Not yet recruiting
• Phase: N/A
• First received: August 14, 2016
• Last updated: September 9, 2016
• Start date: September 2016
• Est. completion date: December 2020

Study information

• Verified date: September 2016
• Source: University of British Columbia
• Contact: Stanley Hung, MSc
• Phone: 604-827-1914
• Email: stanley.hung[@]ubc.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hematological Malignancy

Intervention

Behavioral:
• Exercise
Combination of resistance and aerobic exercises for 100 days.

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Raewyn Broady

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Day 100 post-transplant	No
Secondary	Changes in Quality of Life	EuroQol (EQ)-5 Dimensions (5D) -3 Level (3L) Questionnaire.	Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant	No
Secondary	Changes in Grip Strength	Using a handheld dynamometer, measured in kg.	Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant	No
Secondary	Changes in 30-Second Chair Stand	Number of chair stands one can perform in 30 seconds.	Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant	No
Secondary	Changes in 6-Minute Walk Test	Distance (meters) someone can walk in 6 minutes between two cones separated by 30 meters.	Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant	No
Secondary	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.	Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant	No
Secondary	Changes in Exercise Capacity	Exercise Treadmill Test via Bruce or Modified Bruce Protocol. METs and estimated peak oxygen uptake (VO2) will be determined.	Baseline, Day 100, 365, and 730 post-transplant	No
Secondary	Changes in Cardiopulmonary Function	Left ventricular ejection fraction vs radionuclide ventriculography (MUGA) or echocardiography.	Baseline, Day 100, 365, and 730 post-transplant	Yes
Secondary	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.	Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant	No
Secondary	Changes in Physical Activity Levels - Questionnaire	Godin Leisure-Time Exercise Questionnaire. Total leisure activity score is calculated.	Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant	No
Secondary	Changes in Body Composition Analysis	Height (cm), weight (m), and waist/hip circumference (cm) will be measured.	Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant	No
Secondary	Changes in Bone Mineral Density Analysis	Bone mineral density testing will be performed using a Dual-Energy X-Ray Absorptiometry (DXA).	Baseline, Day 100, 365, and 730 post transplant	No
Secondary	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).	Baseline, Day 100, 365, and 730 post-transplant	Yes