Exercise Prior to Allogeneic Hematologic Stem Cell Transplantation

Not Applicable

Completed

• Conditions: Allogeneic Stem Cell Transplantation
• Interventions: Behavioral: Exercise

• Registration Number: NCT02273024
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-16
• Study First Submitted QC: 2014-10-21
• Study First Posted: 2014-10-23
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-22
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	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.

Primary Outcome Measures

Name	Time	Method
Change in Physical Function	Baseline, 1 week pre HSCT, T100, 1yr post HSCT	Cardiopulmonary Capacity (VO2peak)

Secondary Outcome Measures

Name	Time	Method
Change in Symptoms	Baseline, 1 week pre HSCT, T100, 1yr post HSCT	Memorial Symptom Assessment Scale (MSAS)
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 Six-minute walk test	Baseline, 1 week pre HSCT, T100, 1yr post HSCT
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 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 Strength	Baseline, 1 week pre HSCT, T100, 1yr post HSCT	upper body: grip strength; lower body: chair-stand test

Trial Locations

Locations (1)

Princess Margaret Hospital & Toronto Rehabilitation Institute; 🇨🇦 Toronto, Ontario, Canada