Exercise Prior to Allogeneic Hematologic Stem Cell Transplantation

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT02273024

Collaborator

Princess Margaret Hospital, Canada (Other), Toronto Rehabilitation Institute (Other)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Allogeneic Stem Cell Transplantation	Behavioral: Exercise	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Exercise Therapy for Patients Awaiting Allogeneic Hematological Stem Cell Transplantation

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Aug 1, 2019

Actual Study Completion Date :

Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Exercise
No Intervention: 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.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: Exercise

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

Change in Physical Function [Baseline, 1 week pre HSCT, T100, 1yr post HSCT]
Cardiopulmonary Capacity (VO2peak)

Secondary Outcome Measures

Change in Quality of Life [Baseline, 1 week pre HSCT, T100, 1yr post HSCT]
European Organization for Research and Treatment of Cancer (EORTC) core 30-item questionnaire (QLQ-30)
Change in Symptoms [Baseline, 1 week pre HSCT, T100, 1yr post HSCT]
Memorial Symptom Assessment Scale (MSAS)
Change in Anxiety [Baseline, 1 week pre HSCT, T100, 1yr post HSCT]
The Generalized Anxiety Disorder (GAD7)
Change in Depression [Baseline, 1 week pre HSCT, T100, 1yr post HSCT]
The Patient Health Questionnaire (PHQ-9), will be used as a clinically relevant measure to evaluate depression
Change in Fatigue [Baseline, 1 week pre HSCT, T100, 1yr post HSCT]
Multidimensional Fatigue Inventory
Change in Treatment Side-effects [Baseline, 1 week pre HSCT, T100, 1yr post HSCT]
Hospitalization (days till discharge and readmission rates), bone marrow engraftment (days), graft versus host disease incidence (acute & chronic), severity of diarrhea/ vomiting/ nausea, infections, steroid use, blood counts
Change in Strength [Baseline, 1 week pre HSCT, T100, 1yr post HSCT]
upper body: grip strength; lower body: chair-stand test
Change in Six-minute walk test [Baseline, 1 week pre HSCT, T100, 1yr post HSCT]

Other Outcome Measures

Adherence to exercise sessions [One year]
Feasibility of an exercise intervention prior to HSCT till T100

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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