Exercise Prior to Allogeneic Hematologic Stem Cell Transplantation

Exercise Therapy for Patients Awaiting Allogeneic Hematological Stem Cell Transplantation

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.

Study Overview

• Status: Completed
• Conditions: Allogeneic Stem Cell Transplantation
• Intervention / Treatment: Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T2M9
      • Princess Margaret Hospital & Toronto Rehabilitation Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physical Function	Cardiopulmonary Capacity (VO2peak)	Baseline, 1 week pre HSCT, T100, 1yr post HSCT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life	European Organization for Research and Treatment of Cancer (EORTC) core 30-item questionnaire (QLQ-30)	Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Change in Symptoms	Memorial Symptom Assessment Scale (MSAS)	Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Change in Anxiety	The Generalized Anxiety Disorder (GAD7)	Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Change in Depression	The Patient Health Questionnaire (PHQ-9), will be used as a clinically relevant measure to evaluate depression	Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Change in Fatigue	Multidimensional Fatigue Inventory	Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Change in Treatment Side-effects	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	Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Change in Strength	upper body: grip strength; lower body: chair-stand test	Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Change in Six-minute walk test		Baseline, 1 week pre HSCT, T100, 1yr post HSCT

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to exercise sessions	Feasibility of an exercise intervention prior to HSCT till T100	One year

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Toronto Rehabilitation Institute; Princess Margaret Hospital, Canada
• Investigators: Principal Investigator: Jeff Lipton, MD, PhD, Princess Margaret Hospital, University Health Network

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: October 16, 2014
• First Submitted That Met QC Criteria: October 21, 2014
• First Posted (Estimate): October 23, 2014

Study Record Updates

• Last Update Posted (Actual): November 25, 2019
• Last Update Submitted That Met QC Criteria: November 22, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Exercise; Quality of Life; Fatigue; Prehabilitation; Aerobic Capacity; Symptoms
• Other Study ID Numbers: 14-7699