CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 35 enrolled
Drug / intervention
Interval Exercise Training/Motivational Accelerometrybehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02564458
NCT02564458N/ACompleted

Fitness in Allogeneic Stem Cell Transplantation

UNC Lineberger Comprehensive Cancer Center·interventional·Posted Sep 30, 2015·Updated Jul 6, 2018

In Brief

A clinical study evaluating Interval Exercise Training/Motivational Accelerometry for Hematopoietic Stem Cell Transplantation. Completed, enrolled 35 participants across 1 site.

Detailed Summary

Purpose: The primary hypothesis of this study is that the combination of interval exercise training (IET) as well as motivational accelerometry (MA) delivered both as a 5-12 week intervention that will improve cardiorespiratory fitness in patients preparing to undergo allogeneic hematopoietic cell transplantation (alloHCT). MA is not an established term, but in respect to this study, MA refers to the use of wearable accelerometry paired with regular intervals of physical activity coaching from members of the study staff during the IET training. The study will also look at several secondary endpoints including the association of the intervention with changes in cyclin-dependent kinase inhibitor 2A, multiple tumor suppressor 1 (p16INK4a), and the association of the intervention with changes in symptoms and quality of life before and after transplant. Participants: 60 patients will be randomized into two groups, 30 in the intervention group consisting of both IET and MA, and 30 in the control group applying usual care and use of wearable accelerometry without motivational physical activity coaching. Procedures (methods): Results of this study will inform a randomized, multi-site study of a pre-transplant exercise intervention.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 30, 2015
Enrollment StartSep 1, 2015
Primary CompletionJun 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.8 years ago

Interventions

Interval Exercise Training/Motivational Accelerometrybehavioral

During the 5-12 weeks before allogeneic stem cell transplant, the patient will participate in an at home, interval exercise training (IET) program, as well as wear a physical activity tracker, the FitBit Surge, combined with a weekly motivational call, termed Motivational Accelerometry (MA). The combined intervention is referred to as (IET/MA). The first week of the IET program consists of the participants being asked to engage in 30 minutes of aerobic exercise at any intensity for 3-4 days. For weeks two and beyond, patients be asked to undergo 3-4 sessions of IET, consisting of a 5 minute warm-up and five 2-minute intervals, with the goal of reaching 80% MHR, separated by 3 minutes of recovery/light activity in between each interval. Each exercise session is a total of 30 minutes. In addition, each week prior to transplant, the patient will receive a weekly check-in/motivational call from the study staff in order to track progress and motivate the patient to continue participation.