Exercise Prior to Allogeneic Hematologic Stem Cell Transplantation

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02273024
• Date of registration: 16/10/2014
• Prospective Registration: No
• Primary sponsor: University Health Network, Toronto
• Public title: Exercise Prior to Allogeneic Hematologic Stem Cell Transplantation
• Scientific title: Exercise Therapy for Patients Awaiting Allogeneic Hematological Stem Cell Transplantation
• Date of first enrolment: October 2014
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02273024
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Jeff Lipton, MD, PhD
• Affiliation: Princess Margaret Hospital, University Health Network

Key inclusion & exclusion criteria

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



Age minimum: 17 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Allogeneic Stem Cell Transplantation

Intervention(s)

Behavioral: Exercise

Primary Outcome(s)

Change in Physical Function [Time Frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT]

Secondary Outcome(s)

Change in Anxiety [Time Frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT]

Change in Quality of Life [Time Frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT]

Change in Depression [Time Frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT]

Change in Treatment Side-effects [Time Frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT]

Change in Fatigue [Time Frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT]

Change in Strength [Time Frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT]

Change in Six-minute walk test [Time Frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT]

Change in Symptoms [Time Frame: Baseline, 1 week pre HSCT, T100, 1yr post HSCT]

Secondary ID(s)

14-7699

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Toronto Rehabilitation Institute

Princess Margaret Hospital, Canada