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

Recruiting

• Conditions: Cystic Fibrosis
• Interventions: Diagnostic Test: BMI and lean mass index from DXA; Diagnostic Test: Anthropometric Measurements; Diagnostic Test: Hand-grip strength; Diagnostic Test: Six-minute walk Test; Diagnostic Test: Sit-to-Stand Test; Diagnostic Test: Short physical performance battery (SPPB); Diagnostic Test: BIA Sub-study; Diagnostic Test: Accelerometry to assess physical activity; Other: 12-month Questionnaire; Other: Oral glucose tolerance testing (OGTT); Device: Continuous glucose monitoring (CGM); Diagnostic Test: Chest CT scans (When available within the past 6 months in medical records); Diagnostic Test: Hologic Dual X-Ray Absorptiometry (DXA); Diagnostic Test: Ultrasound Sub-study of assessment of appendage muscles using ultrasound; Diagnostic Test: Spirometry

• Registration Number: NCT05639556
• Lead Sponsor: Jaeb Center for Health Research

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2022-11-28
• Study First Posted: 2022-12-06
• Study Start: 2023-04-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-13
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

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Exclusion Criteria

• No prior solid organ transplantation
• No initiation of an investigation drug within 28 days prior to and including Visit 1
• No initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston, CFTR modulator) within 28 days prior to and including Visit 1.
• No acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within 14 days prior to and including Visit 1.
• For the BIA sub-study - Individuals with an implanted pacemaker will be excluded.
• No initiation of a drug for weight loss (such as a GLP-1 receptor agonist) or bariatric surgery within 6-months prior to and including the Baseline visit.
• Patients with continued rapid change or extreme GI symptoms related to weight loss therapy should be excluded at the discretion of the study investigator.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 2	Spirometry	FEV1 ≥60% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
Cohort 1	BMI and lean mass index from DXA	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.
Cohort 1	BIA Sub-study	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.
Cohort 1	Accelerometry to assess physical activity	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.
Cohort 1	Continuous glucose monitoring (CGM)	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.
Cohort 1	Ultrasound Sub-study of assessment of appendage muscles using ultrasound	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.
Cohort 1	Spirometry	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.
Cohort 2	BMI and lean mass index from DXA	FEV1 ≥60% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
Cohort 2	Sit-to-Stand Test	FEV1 ≥60% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
Cohort 2	Short physical performance battery (SPPB)	FEV1 ≥60% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
Cohort 1	Hand-grip strength	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.
Cohort 2	Oral glucose tolerance testing (OGTT)	FEV1 ≥60% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
Cohort 1	Six-minute walk Test	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.
Cohort 1	Sit-to-Stand Test	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.
Cohort 1	Short physical performance battery (SPPB)	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.
Cohort 2	Six-minute walk Test	FEV1 ≥60% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
Cohort 2	BIA Sub-study	FEV1 ≥60% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
Cohort 2	12-month Questionnaire	FEV1 ≥60% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
Cohort 2	Continuous glucose monitoring (CGM)	FEV1 ≥60% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
Cohort 1	Anthropometric Measurements	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.
Cohort 1	12-month Questionnaire	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.
Cohort 1	Oral glucose tolerance testing (OGTT)	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.
Cohort 2	Anthropometric Measurements	FEV1 ≥60% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
Cohort 2	Chest CT scans (When available within the past 6 months in medical records)	FEV1 ≥60% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
Cohort 1	Chest CT scans (When available within the past 6 months in medical records)	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.
Cohort 2	Accelerometry to assess physical activity	FEV1 ≥60% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
Cohort 1	Hologic Dual X-Ray Absorptiometry (DXA)	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.
Cohort 2	Hand-grip strength	FEV1 ≥60% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
Cohort 2	Hologic Dual X-Ray Absorptiometry (DXA)	FEV1 ≥60% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
Cohort 2	Ultrasound Sub-study of assessment of appendage muscles using ultrasound	FEV1 ≥60% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).

Primary Outcome Measures

Name	Time	Method
Correlation between DXA lean mass index and BMI	Baseline and 1 year	Estimate and compare correlation between lean mass index from DXA (kg/m2) and BMI (kg/m2)
Correlation between DXA lean mass index and mid-arm muscle circumference	Baseline and 1 year	Estimate and compare correlation between lean mass index from DXA (kg/m2) and mid-arm muscle circumference (cm)
Correlation between DXA lean mass index and the 6-minute walk distance traveled	Baseline and 1 year	Estimate and compare correlation between lean mass index from DXA (kg/m2) and 6-minute walk (distance traveled in six minutes)
Correlation between DXA lean mass index and the 1-minute sit-to-stand number of repetitions	Baseline and 1 year	Estimate and compare correlation between lean mass index from DXA (kg/m2) and 1-minute sit-to-stand (number of sit-to-stand repetitions in one minute)
Correlation between DXA lean mass index and hand-grip strength	Baseline and 1 year	Estimate and compare correlation between lean mass index from DXA (kg/m2) and hand-grip strength (kg)
Correlation between DXA lean mass index and Short Physical Performance Battery frailty score	Baseline and 1 year	Estimate and compare correlation between lean mass index from DXA (kg/m2) and Short Physical Performance Battery frailty score (total points)

Secondary Outcome Measures

Name	Time	Method
Characterize lean mass index from DXA cross-sectionally and longitudinally	Baseline and 1 year	Characterize lean mass index from DXA cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
Characterize BMI cross-sectionally and longitudinally	Baseline and 1 year	Characterize lean mass index from BMI cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
Characterize hand-grip strength cross-sectionally and longitudinally	Baseline and 1 year	Characterize hand-grip strength cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
Compare BMI between participants with FEV1 <60% to matched participants with FEV1 ≥60%	Baseline and 1 year	Compare BMI between participants with FEV1 \<60% to matched participants with FEV1 ≥60%.
Characterize mid-arm measurement circumference cross-sectionally and longitudinally	Baseline and 1 year	Characterize lean mass index from mid-arm circumference measurements cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
Characterize 1 minute sit-to-stand repetitions cross-sectionally and longitudinally	Baseline and 1 year	Characterize the 1 minute sit-to-stand repetitions cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
Characterize the Short Physical Performance Battery frailty score cross-sectionally and longitudinally	Baseline and 1 year	Characterize the Short Physical Performance Battery frailty score cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
Compare lean mass index from DXA between participants with FEV1 <60% to matched participants with FEV1 ≥60%	Baseline and 1 year	Compare lean mass index from DXA between participants with FEV1 \<60% to matched participants with FEV1 ≥60%.
Compare the Short Physical Performance Battery frailty score between participants with FEV1 <60% to matched participants with FEV1 ≥60%	Baseline and 1 year	Compare the Short Physical Performance Battery frailty score between participants with FEV1 \<60% to matched participants with FEV1 ≥60%.
Characterize mid-arm 6-minute walk test distance traveled cross-sectionally and longitudinally	Baseline and 1 year	Characterize the 6-minute walk test distance traveled cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
Compare the 1-minute sit-to-stand repetitions between participants with FEV1 <60% to matched participants with FEV1 ≥60%	Baseline and 1 year	Compare the 1-minute sit-to-stand repetitions between participants with FEV1 \<60% to matched participants with FEV1 ≥60%.
Evaluate the coefficient of variation in CGM glucose data in participants with FEV1 <60% and matched participants with FEV1 ≥60%participants with FEV1 ≥60%	Baseline and 1 year	Evaluate the coefficient of variation in CGM glucose data in participants with FEV1 \<60% and matched participants with FEV1 ≥60%participants with FEV1 ≥60%
Compare lean mass index from mid-arm muscle circumference between participants with FEV1 <60% to matched participants with FEV1 ≥60%	Baseline and 1 year	Compare lean mass index from mid-arm muscle circumference between participants with FEV1 \<60% to matched participants with FEV1 ≥60%.
Compare hand-grip strength between participants with FEV1 <60% to matched participants with FEV1 ≥60%	Baseline and 1 year	Compare hand-grip strength between participants with FEV1 \<60% to matched participants with FEV1 ≥60%.
Compare the 6-minute walk test distance between participants with FEV1 <60% to matched participants with FEV1 ≥60%	Baseline and 1 year	Compare the 6-minute walk test distance between participants with FEV1 \<60% to matched participants with FEV1 ≥60%.
Evaluate peak glucose in participants with FEV1 <60% and matched participants with FEV1 ≥60%	Baseline and 1 year	Evaluate peak glucose from continuous glucose measurement data in participants with FEV1 \<60% and matched participants with FEV1 ≥60%
Evaluate % time below 70 mg/dL in participants with FEV1 <60% and matched participants with FEV1 ≥60%	Baseline and 1 year	Evaluate % time below 70 mg/dL from continuous glucose measurement data in participants with FEV1 \<60% and matched participants with FEV1 ≥60%
Evaluate % time below 54 mg/dL in participants with FEV1 <60% and matched participants with FEV1 ≥60%	Baseline and 1 year	Evaluate % time below 54 mg/dL from continuous glucose measurement data in participants with FEV1 \<60% and matched participants with FEV1 ≥60%
Evaluate the standard deviation in CGM glucose data in participants with FEV1 <60% and matched participants with FEV1 ≥60%	Baseline and 1 year	Evaluate the standard deviation in CGM glucose data in participants with FEV1 \<60% and matched participants with FEV1 ≥60%
Evaluate mean glucose in participants with FEV1 <60% and matched participants with FEV1 ≥60%	Baseline and 1 year	Evaluate mean glucose from continuous glucose measurement data in participants with FEV1 \<60% and matched participants with FEV1 ≥60%
Evaluate % time above 140 mg/dL in participants with FEV1 <60% and matched participants with FEV1 ≥60%	Baseline and 1 year	Evaluate % time above 140 mg/dL from continuous glucose measurement data in participants with FEV1 \<60% and matched participants with FEV1 ≥60%
Evaluate % time above 180 mg/dL in participants with FEV1 <60% and matched participants with FEV1 ≥60%	Baseline and 1 year	Evaluate % time above 180 mg/dL from continuous glucose measurement data in participants with FEV1 \<60% and matched participants with FEV1 ≥60%

Trial Locations

Locations (23)

Washington University School of Medicine (St. Louis); 🇺🇸 Saint Louis, Missouri, United States

University of Virginia Cystic Fibrosis Center; 🇺🇸 Charlottesville, Virginia, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Massachusetts General Hospital (MGH); 🇺🇸 Boston, Massachusetts, United States

University of Arizona; 🇺🇸 Tucson, Arizona, United States

University of Arkansas for Medical Sciences (UAMS); 🇺🇸 Little Rock, Arkansas, United States

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

New York Medical College (NYMC); 🇺🇸 Hawthorne, New York, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Boston Children's Hospital and Brigham and Women's CF Center; 🇺🇸 Boston, Massachusetts, United States

Northwell LIJ Adult Cystic Fibrosis Center; 🇺🇸 New Hyde Park, New York, United States

Emory; 🇺🇸 Atlanta, Georgia, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

John Hopkins University; 🇺🇸 Baltimore, Maryland, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

University Hospitals; 🇺🇸 Cleveland, Ohio, United States

University of Oklahoma Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Baylor University; 🇺🇸 Houston, Texas, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Tulane University; 🇺🇸 New Orleans, Louisiana, United States