Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF

Recruiting in Palo Alto (17 mi)

+26 other locations

Overseen byJessica Alvarez

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Jaeb Center for Health Research

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of the study is to examine multiple markers of anthropometrics, body composition, sarcopenia and frailty and compare them to dual energy X-ray absorptiometry (DXA) output, which is considered the current clinical gold-standard tool to measure body composition. The result of this study will provide detailed data regarding the nutrition and body composition within this Cystic Fibrosis population and also provide a baseline evaluation for use of these biomarkers in the future studies including evaluation of nutritional intervention. Further, the study will also include psychosocial and other patient-reported outcomes and medical contributors to understand their contributions to the nutritional failure in the adult advanced lung disease population. Finally, the study will evaluate both established and emerging nutritional and body composition parameters and link them to clinical outcomes in adults with CF across the spectrum of pulmonary function.

Research Team

Melissa Putman

Principal Investigator

Massachusetts General Hospital

Adam Stein

Principal Investigator

Northwestern University

Jessica Alvarez

Principal Investigator

Emory University

Eligibility Criteria

Inclusion Criteria

Cohort 1: Patients are eligible if their percentage of predicated forced expiratory volume in1 second (FEV1) is 60% or lower at screening.

Cohort 2: Patients are eligible if their percentage of predicted forced expiratory volume in 1 second (FEV1) is 60% or greater at screening.

Both cohorts match by age, gender, race and CFTR genotype severity.

Treatment Details

Interventions

1-minute site to stand (Diagnostic Test)
1 minute site to stand and lean mass index from DXA (Diagnostic Test)
6-minute walk (Diagnostic Test)
6 minute walk and lean mass index from DXA (Diagnostic Test)
Accelerometry to assess physical activity (Diagnostic Test)
BIA Substudy (Diagnostic Test)
BIA Sub-study (Diagnostic Test)
BMI and lean mass index from DXA (Diagnostic Test)
Chest CT scans (Diagnostic Test)
Chest CT scans (When available within the past 6 months) to assess (Diagnostic Test)
Continuous glucose monitoring (CGM) (Diagnostic Test)
Food logging (Nutrition)
Gastrointestinal (GI) and nutrition questionnaires (Diagnostic Test)
Hand-grip strength (Diagnostic Test)
Hand-grip strength and lean mass index from DXA (Diagnostic Test)
Hologic Dual X-Ray Absorptiometry (DXA) (Diagnostic Test)
Hunger Vital Sign (Diagnostic Test)
Oral glucose tolerance testing (OGTT) (Diagnostic Test)
Psychosocial questionnaire: Body Esteem Scale for Adolescents and Adults (BESAA) (Diagnostic Test)
Psychosocial questionnaire: CF Fatalism Scale (Diagnostic Test)
Psychosocial questionnaire: GAD-7 (Diagnostic Test)
Psychosocial questionnaire: PHQ-8 (Diagnostic Test)
Psychosocial questionnaire: The Treatment Self-Regulation Questionnaire (TSRQ) (Diagnostic Test)
Respiratory symptom questionnaire: CRISS (Diagnostic Test)
Short physical performance battery (SPPB) (Diagnostic Test)
Short physical performance battery (SPPB) frailty score and lean mass index from DXA (Diagnostic Test)
skinfold and circumference (Diagnostic Test)
Spirometry (Diagnostic Test)
STRONG Participant Experience Survey (Diagnostic Test)
Sub-study of assessment of appendage muscles using ultrasound (Diagnostic Test)
Tricepts skinfold (TSF) and Mid-arm muscle circumference (MAMC) and lean mass index from DXA (Diagnostic Test)
Ultrasound Sub-study of assessment of appendage muscles using ultrasound (Diagnostic Test)

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Cohort 2Experimental Treatment24 Interventions

FEV1 ≥60% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).

Group II: Cohort 1Experimental Treatment24 Interventions

Forced expiratory volume in 1 second (FEV1) \<60% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation). If no stable spirometry data are available in the 12 months prior to enrollment, from the prior 24 months will be used.