NCT02577939|CompletedDMC
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Sponsor study identifier
interventional
40
1 country
1
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2015
Actual (reported)Study Completion
June 2015
Actual (reported)The primary objective of this study is to demonstrate the efficacy of a pre-transplant, interval exercise training (IET) intervention, in increasing peak oxygen uptake (VO2peak) scores on cycle ergometry. This study will have a lead-in phase to ensure that IET is feasible in this population. Secondary objectives include documenting the safety of IET in this population, evaluating the correlation of VO2peak with other methods of measuring pre-transplant cardiorespiratory performance, comparing the 6 minute walk distance (6MWD) pre and post IET, and establishing the feasibility of the 6MWD when performed unsupervised by a health care professional. Eligible patients include 40 evaluable autologous (n=20) and allogeneic (n=20; 10 full intensity and 10 reduced intensity) transplant patients deemed appropriate for exercise intervention by their treating physician. The investigators will enroll no more than 50 patients onto this trial. Results of this study will inform a randomized, multi-site study of a pre-transplant exercise intervention.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
February 20, 2015
Actual (reported)March 2015
Actual (reported)June 2015
Actual (reported)October 16, 2015
Actual (reported)Of those patients with heart rate data, number and percent of patients able to achieve 65-85% heart rate during one or more exercise sessions. Unit of measurement: number of patients and percent of patients with evaluable heart rate data.
Establish the feasibility of IET in patients prior to autologous or allogeneic transplantation. Feasibility is defined as 5 of the first 10 evaluable patients being able to achieve 65-85% heart rate during one or more exercise sessions throughout the duration of the interval exercise training.
During the 6 weeks of IET pre-transplant
Number of adverse events as reported by patients and determined by study investigators. Unit of measurement: cumulative number of adverse events.
During the 6 weeks of IET pre-transplant
Change in 6 minute walk distance based on pre- and post- intervention 6 minute walk distance testing. Unit of measurement: meters.
Pre- and Post- Assessment for 6 weeks of IET
Change in VO2peak based on pre- and post- intervention VO2peak measurement from cardiopulmonary exercise testing. Unit of measurement: ml/kg*min.
Pre- and Post- Assessment for 6 weeks of IET
This is a single arm study. All patients receive the intervention of 6 weeks of pre-transplant IET, pre- and post-tests, and data collection via FitBit accelerometer and weekly surveys.
This is a single arm study. All patients receive the intervention of 6 weeks of pre-transplant IET, pre- and post-tests, and data collection via FitBit accelerometer and weekly surveys.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514, United States
William A Wood, MD
UNC Lineberger Comprehensive Cancer Center
40 participants (actual enrollment reported by the registry).
First Submitted
February 20, 2015
First Posted
October 16, 2015
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
March 2015
Actual (reported)Study Completion
June 2015
Actual (reported)Last Updated
October 16, 2015
Record last verified: 2015-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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