Exercise Prior to Allogeneic Hematologic Stem Cell Transplantation

NCT ID: NCT02273024

Last Updated: 2019-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2019-08-31

Brief Summary

The investigators hypothesize that inactivity during the search for a donor may exacerbate current deconditioned states; subsequently, influencing risk factors for post-transplant complications that hinder the recovery phase.

This study is designed to investigate if exercise therapy administered prior to allogeneic hematologic stem cell transplantation (HSCT) can influence physical and psychological side-effects associated with HSCT. Approximately 6-weeks prior to HSCT, individuals will be randomized into either an exercise group or usual care group and followed until one year after HSCT.

Conditions

Allogeneic Stem Cell Transplantation

Study Design

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

Study Groups

Exercise

Individuals will participate in weekly supervised and unsupervised exercise sessions prior to HSCT, during hospitalization and till 100 days from HSCT. Exercise will consist of endurance and resistance exercise 3-5 days a week.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

Usual Care

Usual care will have continue with standard of care treatment without any specific exercise instruction or guidance other than what is provided by the patient education team at the cancer centre.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Medical indication: allogeneic stem cell transplantation at Princess Margaret Hospital
• must be ambulatory without need for human assistance at time of recruitment
• medically cleared to exercise by the transplant physician
• demonstrates willingness to attend supervised sessions
• sufficient in English to ensure safety of understanding prescribed exercise guidelines, or has access to an adequate non-familial interpreter

Exclusion Criteria

• another active malignancy
• less than 4 weeks till the scheduled HSCT
• refusal to be randomized
• does not have the approval of their transplant physician
• severe or unstable neurological, cardiorespiratory, musculoskeletal disease or mental illness

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Princess Margaret Hospital, Canada

OTHER

Sponsor Role: collaborator

Toronto Rehabilitation Institute

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeff Lipton, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, University Health Network

Locations

Princess Margaret Hospital & Toronto Rehabilitation Institute

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

14-7699

Identifier Type: -

Identifier Source: org_study_id