Effects of Exercise on Allogeneic Stem Cell Transplant

NCT02900768 | Unknown DMC

• 1 other identifier: H16-00112
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematological Malignancy

Keywords

Bone Marrow Transplantation; Exercise; Rehabilitation; Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• Changes in Quality of Life

  Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant

• Changes in Grip Strength

  Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant

• Changes in 30-Second Chair Stand

  Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant

• Changes in 6-Minute Walk Test

  Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant

• Changes in Timed Up and Go

  Baseline, Hospital Discharge (approximately +30 days post-transplant), Day 60, 100, 365, and 730 post-transplant

Study Arms (2)

Exercise Group

EXPERIMENTAL

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

Behavioral: Exercise

Control Group

NO INTERVENTION

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

Interventions

Exercise BEHAVIORAL

Combination of resistance and aerobic exercises for 100 days.

Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age greater than or equal to 18 years.
• Able to provide written informed consent.

You may not qualify if:

• Severe cardiac disease including symptomatic congestive heart failure (New York Heart Association Class III or IV), unstable angina pectoris, or an unstable cardiac arrhythmia.
• Orthopedic illness which limits ability to conduct aerobic exercise (walking or biking).
• Not meeting eligibility criteria to proceed with allogeneic stem cell transplantation as per the Leukemia/BMT Program of BC.

Sponsors & Collaborators

• Raewyn Broady: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Motor Activity; Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Alina Gerrie, MD, FRCPC

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

• Raewyn Broady, MBChB, FRCPC

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stanley Hung, MSc

CONTACT

604-827-1914; stanley.hung@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: August 14, 2016
• First Posted: September 14, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 14, 2016

Record last verified: 2016-09

Locations

CA (1)