Pittsburgh, Pennsylvania 15261


Purpose:

Estimated costs, from thirty days prior to lung transplant up through six months post surgery, exceed 1 million dollars per patient and routine medical costs average approximately fifty thousand dollars per year thereafter. Prior to transplant, lung transplant recipients self restrict activity due to severe respiratory limitations, resulting in reduced muscle mass and qualitative changes in large skeletal muscles. After transplant, despite improved lung function, studies consistently report that lung recipients fail to reach predicted physical function and physical activity. Nearly seventy percent are at risk of developing hypertension within the first five years due to side effects of immunosuppression and an inactive lifestyle worsens this risk. Consequently, full benefits of transplant may not be achieved. Few studies have tested ways to engage lung recipients in self management of exercise and adopt an active lifestyle. Lung Transplant Go LTGO is a behavioral exercise intervention that provides individualized exercise training integrated with behavioral coaching delivered in the recipient's home. Exercise training will focus on assisting lung recipients to learn and practice exercises to reverse muscle conditioning. Behavioral coaching will assist them to develop the skills to self manage physical activity in daily life and maintain this as a sustained habit using strategies that include incremental goal setting, self-monitoring, feedback and problem solving.


Study summary:

This is a two-group randomized controlled trial comparing LTGO to enhanced usual care (EUC). Participants will be 112 LTR randomized to LTGO or EUC (1:1). The biostatistician will randomize participants using a blocked randomization scheme, stratified by sex (male vs. female) and length of hospital stay (≤2 wks vs.>2 wks). The block size (2 or 4) will be randomly selected to prevent prediction of group assignment. An "intention-to-treat" (ITT) approach will be used. All subjects will be analyzed in the group to which they were randomly assigned, regardless of adherence to the protocol, treatment received, and/or withdrawal from the protocol. Endorsed by international regulatory guidelines, the ITT approach is widely used in RCT because it minimizes the potential for the introduction of biases into data analysis and maintains prognostic balance generated from original random treatment allocation. Although the ITT approach is recommended for efficacy analysis in RCTs, the sensitivity of the results assumes that ITT will be explored using information collected regarding fidelity and dosage (e.g., number of sessions completed).


Criteria:

Inclusion Criteria: - 18 years of age or older - Approved by your transplant physician to participate in this research study - Discharged from the hospital after your lung transplant - 4 weeks after the participant had lung transplant surgery - Experiencing difficulty walking a short distance or climbing steps without resting Exclusion Criteria: - concurrent participation in a formal exercise program, e.g., pulmonary rehabilitation, during the study period (Rationale: to ensure internal validity) - current residence located > 120 miles from data collection site (Rationale: setting up the VISYTER system requires a home visit) - having other chronic conditions that may limit participation in exercise training, i.e., cardiac, musculoskeletal or cognitive impairments (Rationale: lung transplant recipients may have other comorbid conditions).


NCT ID:

NCT03728257


Primary Contact:

Principal Investigator
Annette DeVito Dabbs, PhD
University of Pittsburgh

Annette DeVito Dabbs, PhD
Phone: 4126245314
Email: ajdst42@pitt.edu


Backup Contact:

N/A


Location Contact:

Pittsburgh, Pennsylvania 15261
United States

Annette DeVito Dabbs, PhD

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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