Clinical trial NCT02273024: Exercise Prior to Allogeneic Hematologic Stem Cell Transplantation
Official title: Exercise Therapy for Patients Awaiting Allogeneic Hematological Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allogeneic Stem Cell Transplantation
Keywords: Exercise
Quality of Life
Fatigue
Symptoms
Prehabilitation
Aerobic Capacity
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
name: Toronto Rehabilitation Institute
First posted: 2014-10-23
Enrollment: 30
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in Physical Function
timeFrame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
measure: Change in Symptoms
timeFrame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
measure: Change in Anxiety
timeFrame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
measure: Change in Depression
timeFrame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
measure: Change in Fatigue
timeFrame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
measure: Change in Treatment Side-effects
timeFrame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
measure: Change in Strength
timeFrame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
measure: Change in Six-minute walk test
timeFrame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Other outcomes:
measure: Adherence to exercise sessions
timeFrame: One year
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital & Toronto Rehabilitation Institute
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, University Health Network
name: Jeff Lipton, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: