Effects of Exercise on Allogeneic Stem Cell Transplant

NCT ID: NCT02900768

Last Updated: 2016-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2020-12-31

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.

Conditions

Hematological Malignancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Exercise Group

Patients in the intervention group will receive supervised and unsupervised exercise program after their bone marrow transplant.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

Combination of resistance and aerobic exercises for 100 days.

Control Group

Patient will receive standard of care within the hospital as an inpatient and outpatient after their bone marrow transplant.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

Combination of resistance and aerobic exercises for 100 days.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Raewyn Broady

OTHER

Sponsor Role: lead

Responsible Party

Raewyn Broady

Clinical Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alina Gerrie, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

British Columbia Cancer Agency

Raewyn Broady, MBChB, FRCPC

Role: PRINCIPAL_INVESTIGATOR

British Columbia Cancer Agency

Locations

Vancouver General Hospital

Vancouver, British Columbia, Canada

Countries

Canada

Central Contacts

Stanley Hung, MSc

Role: CONTACT

stanley.hung@ubc.ca

604-827-1914

Facility Contacts

Alina Gerrie, MD

Role: primary

agerrie@bccancer.bc.ca

604-875-4863

Other Identifiers

H16-00112

Identifier Type: -

Identifier Source: org_study_id