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NCT Number: NCT02273024

Exercise Prior to Allogeneic Hematologic 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.

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Key information

Conditions

Allogeneic Stem Cell Transplantation Behavior Fatigue Motor Activity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Hospital & Toronto Rehabilitation Institute

Toronto, Ontario, M5T2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

Primary outcomes

  1. Change in Physical Function

    Time frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT

    Cardiopulmonary Capacity (VO2peak)

Secondary outcomes

  1. Change in Quality of Life

    Time frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT

    European Organization for Research and Treatment of Cancer (EORTC) core 30-item questionnaire (QLQ-30)

  2. Change in Symptoms

    Time frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT

    Memorial Symptom Assessment Scale (MSAS)

  3. Change in Anxiety

    Time frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT

    The Generalized Anxiety Disorder (GAD7)

  4. Change in Depression

    Time frame: 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

  5. Change in Fatigue

    Time frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT

    Multidimensional Fatigue Inventory

  6. Change in Treatment Side-effects

    Time frame: 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

  7. Change in Strength

    Time frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT

    upper body: grip strength; lower body: chair-stand test

  8. Change in Six-minute walk test

    Time frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT

Other outcomes

  1. Adherence to exercise sessions

    Time frame: One year

    Feasibility of an exercise intervention prior to HSCT till T100

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Princess Margaret Hospital, Canada
  • Toronto Rehabilitation Institute

Registry information

Official study title

Exercise Therapy for Patients Awaiting Allogeneic Hematological Stem Cell Transplantation

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Oct 23, 2014
Registry last updated
Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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