NCT02320942

Brief Summary

This study is a preliminary study to assess whether it is possible to introduce an exercise program for BMT patients after discharge from hospital. The exercise program will include 3 endurance (stationary bike, walking) and 2 resistance (weights, stretch bands) training sessions/week, until 100 days after BMT. Our second plan is to test changes in QoL, aerobic fitness, muscle strength, total body fat and mineral composition, and blood immune markers with exercise in the 100 days after BMT. The investigators anticipate this study will improve the QoL, mobility, and strength of patients after BMT, therefore allowing a faster and healthier recovery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable leukemia

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable leukemia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 26, 2015

Status Verified

August 1, 2015

Enrollment Period

1.2 years

First QC Date

December 16, 2014

Last Update Submit

August 24, 2015

Conditions

Keywords

Bone Marrow TransplantationExerciseRehabilitationCancer

Outcome Measures

Primary Outcomes (1)

  • Quality of Life

    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).

    Approximately 12-weeks

Secondary Outcomes (5)

  • Baseline Demographics

    Baseline: pre-BMT visit.

  • Aerobic Fitness

    Approximately 12-weeks

  • Muscle Strength

    Approximately 12-weeks

  • Body Composition

    Approximately 12-weeks

  • Immune Function

    Approximately 12-weeks

Study Arms (1)

Exercise Intervention

EXPERIMENTAL

At discharge from the inpatient unit, participants will receive a practical introduction by an exercise specialist and enrolled in the 12-week exercise intervention

Other: Exercise Intervention

Interventions

The semi-supervised intervention is a progressive program with a goal of three aerobic and two resistance exercise sessions per week. Aerobic exercise will consist of 20-40 minutes of bicycling using a stationary bike located on CP6 (supervised or un-supervised) or brisk walking at home. Resistance exercise will include exercise for the upper and lower extremities with stretch bands. Patients will complete at least one supervised aerobic and resistance session per week with the exercise trainer and complete a daily log of their exercise, including adherence, adverse events and symptoms.

Exercise Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ≥ 18 years of age
  • Undergoing alloHSCT for any indication through the LBMT Program of BC at VGH
  • Good comprehension of English (must be able to fill out questionnaires in English)

You may not qualify if:

  • Contraindications to entrance into an exercise program (i.e., known cardiovascular disease, musculoskeletal issue or not cleared for exercise by the attending physician)
  • Mobility impairment requiring use of mobility aids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver General Hospital - Krall Centre Centennial Pavilion 6

Vancouver, British Columbia, V5Z1M9, Canada

RECRUITING

MeSH Terms

Conditions

LeukemiaMotor ActivityNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesBehavior

Study Officials

  • Raewyn Broady, MBChB

    British Columbia Cancer Agency

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2014

First Posted

December 19, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 26, 2015

Record last verified: 2015-08

Locations