Lung Transplant G0 (LTGO): Improving Self-Management of Exercise After Lung Transplantation
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Exercise
- Lung Transplantation
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: There will be two groups. The research study that will compare two methods of self-managing exercise after receiving a lung transplant. These methods are a home-based exercise program plus self-monitoring or self-monitoring alone. The investigator would also like to collect information about the patients health and ability to exercise, and the amount of physical activity the participants do per day. The length of the study will be 6 months.Masking: Double (Care Provider, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a two-group randomized controlled trial comparing LTGO to enhanced usual care (EUC). Based on estimations using a published RCT, effect sizes measured by Cohen's d ranged from 0.64 to 1.45 across outcome variables (i.e., 0.64 for physical function; 0.73-0.99 for physical activity; and 1.19 a...
This is a two-group randomized controlled trial comparing LTGO to enhanced usual care (EUC). Based on estimations using a published RCT, effect sizes measured by Cohen's d ranged from 0.64 to 1.45 across outcome variables (i.e., 0.64 for physical function; 0.73-0.99 for physical activity; and 1.19 and1.45 for systolic and diastolic BP with 80% power, ?=0.05). With a final sample of 80 subjects (40 per group) we will have 80% power to detect an effect size as small as 0.64 (?=0.05, two-tailed) from independent sample t-test for measures of physical function, physical activity and hypertension onset/control. Recruiting and randomizing 112 individuals (56 in LTGO & 56 in EUC) will allow for up to 30% attrition. Participants will be 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).
Tracking Information
- NCT #
- NCT03728257
- Collaborators
- National Institute of Nursing Research (NINR)
- Investigators
- Principal Investigator: Annette DeVito Dabbs, PhD University of Pittsburgh
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