Exercise Prior to Allogeneic Hematologic Stem Cell Transplantation

Allogeneic Stem Cell Transplantation Clinical Trial

Official title:

Exercise Therapy for Patients Awaiting Allogeneic Hematological Stem Cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02273024
• Other study ID #: 14-7699
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: August 2019

Study information

• Verified date: November 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allogeneic Stem Cell Transplantation

Intervention

Behavioral:
• Exercise

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital & Toronto Rehabilitation Institute	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada, Toronto Rehabilitation Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence to exercise sessions	Feasibility of an exercise intervention prior to HSCT till T100	One year
Primary	Change in Physical Function	Cardiopulmonary Capacity (VO2peak)	Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Secondary	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
Secondary	Change in Symptoms	Memorial Symptom Assessment Scale (MSAS)	Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Secondary	Change in Anxiety	The Generalized Anxiety Disorder (GAD7)	Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Secondary	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
Secondary	Change in Fatigue	Multidimensional Fatigue Inventory	Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Secondary	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
Secondary	Change in Strength	upper body: grip strength; lower body: chair-stand test	Baseline, 1 week pre HSCT, T100, 1yr post HSCT
Secondary	Change in Six-minute walk test		Baseline, 1 week pre HSCT, T100, 1yr post HSCT