Exercise Prior to Allogeneic Hematologic Stem Cell Transplantation

NCT02273024 | Completed

• 1 other identifier: 14-7699
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Allogeneic Stem Cell Transplantation

Keywords

Exercise; Quality of Life; Fatigue; Symptoms; Prehabilitation; Aerobic Capacity

Outcome Measures

Primary Outcomes (1)

• Change in Physical Function

  Cardiopulmonary Capacity (VO2peak)

  Baseline, 1 week pre HSCT, T100, 1yr post HSCT

Secondary Outcomes (8)

• Change in Quality of Life

  Baseline, 1 week pre HSCT, T100, 1yr post HSCT

• Change in Symptoms

  Baseline, 1 week pre HSCT, T100, 1yr post HSCT

• Change in Anxiety

  Baseline, 1 week pre HSCT, T100, 1yr post HSCT

• Change in Depression

  Baseline, 1 week pre HSCT, T100, 1yr post HSCT

• Change in Fatigue

  Baseline, 1 week pre HSCT, T100, 1yr post HSCT

Other Outcomes (1)

• Adherence to exercise sessions

  One year

Study Arms (2)

Exercise

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

Exercise BEHAVIORAL

Exercise

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator
• Toronto Rehabilitation Institute: collaborator

Study Sites (1)

Princess Margaret Hospital & Toronto Rehabilitation Institute

Toronto, Ontario, M5T2M9, Canada

Location

MeSH Terms

Conditions

Motor Activity; Fatigue

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jeff Lipton, MD, PhD

  Princess Margaret Hospital, University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 23, 2014
• Study Start: October 1, 2014
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: November 25, 2019

Record last verified: 2019-11

Locations

CA (1)