Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF
1 other identifier
observational
300
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2023
Longer than P75 for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2022
CompletedFirst Posted
Study publicly available on registry
December 6, 2022
CompletedStudy Start
First participant enrolled
April 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
March 13, 2026
March 1, 2026
5.6 years
November 14, 2022
March 11, 2026
Conditions
Outcome Measures
Primary Outcomes (6)
Correlation between DXA lean mass index and BMI
Estimate and compare correlation between lean mass index from DXA (kg/m2) and BMI (kg/m2)
Baseline and 1 year
Correlation between DXA lean mass index and mid-arm muscle circumference
Estimate and compare correlation between lean mass index from DXA (kg/m2) and mid-arm muscle circumference (cm)
Baseline and 1 year
Correlation between DXA lean mass index and hand-grip strength
Estimate and compare correlation between lean mass index from DXA (kg/m2) and hand-grip strength (kg)
Baseline and 1 year
Correlation between DXA lean mass index and the 6-minute walk distance traveled
Estimate and compare correlation between lean mass index from DXA (kg/m2) and 6-minute walk (distance traveled in six minutes)
Baseline and 1 year
Correlation between DXA lean mass index and the 1-minute sit-to-stand number of repetitions
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)
Baseline and 1 year
Correlation between DXA lean mass index and Short Physical Performance Battery frailty score
Estimate and compare correlation between lean mass index from DXA (kg/m2) and Short Physical Performance Battery frailty score (total points)
Baseline and 1 year
Secondary Outcomes (22)
Characterize lean mass index from DXA cross-sectionally and longitudinally
Baseline and 1 year
Characterize BMI cross-sectionally and longitudinally
Baseline and 1 year
Characterize mid-arm measurement circumference cross-sectionally and longitudinally
Baseline and 1 year
Characterize hand-grip strength cross-sectionally and longitudinally
Baseline and 1 year
Characterize 1 minute sit-to-stand repetitions cross-sectionally and longitudinally
Baseline and 1 year
- +17 more secondary outcomes
Study Arms (2)
Cohort 1
Forced expiratory volume in 1 second (FEV1) \<70% 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
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
Interventions
Skinfold will be assessed with calipers. Circumference will be measured with a tape measure.
This will be another functional assessment of fitness. Participants will be asked to walk at their normal pace for 6 minutes.The total distance walked in that time will be measured.
This will be used as a functional assessment of fitness and lower extremity strength. Participants will start seated on a chair and be asked to complete as many sit-to-stand repetitions without using their arms for one minute.
This is an assessment of frailty. The test is completed in approximately 8 minutes. The test consists of 3 assessments: 1) Balance tests where the participant stands and tries to balance with their feet in various positions for 10 seconds each without assistance (side-by-side, heel-to-side, and heel-to-toe); 2) Two 4-meter gait speed tests; and 3) Chair-stand tests (single chair stand, 5 chair stands).
A minimum of 50 individuals will be enrolled. Body composition will be assessed at each study visit using study bioelectrical impendence analysis (BIA).
Participants will be provided with a wrist-worn accelerometer/heart rate monitor at the baseline study visit and asked to wear it continuously for at least 3-10 days (two weekdays, one weekend day). Approximately every 3 months, the participant will be asked to again wear the accelerometer. Participants will be able to keep their accelerometers.
A small, handheld dynamometer will be used to measure grip strength, a measure of function, on each hand.
Estimate and compare correlation between lean mass index from DXA and BMI
Subjects will complete surveys regarding gastrointestinal (GI) symptoms, including the Patient Assessment of Constipation (PAC-SYM) Score, Patient Assessment of Gastrointestinal Symptoms (PACGI-SYM) Score, the Bristol Stool Chart, and the scored Patient-Generated Subjective Global Assessment (PG-SGA).
This is an 8-item scale that measures depressive symptoms over the past two weeks.
This is a 7-items scale that measures anxiety symptoms over the past two weeks, from not at all to nearly every day.
This is a 15-item scale that assesses the degree to which participants' motivation is autonomous or self-regulated.
The CF Fatalism Scale measures the belief in a lack of personal power or control over one's future and has 13 items.
The Body Esteem Scale for Adolescents and Adults (BESAA) is 23-item measurement of self-evaluations of one's body or appearance.
A short questionnaire designed to explore participants' perspectives of the acceptability and feasibility of nutritional assessments used in STRONG-CF will be given to all study participants at the end of the study.
For subjects without previously diagnosed CFRD, an OGTT will be performed at baseline and 12-months with samples analyzed at the central lab.
Subjects will wear a Dexcom G6Pro sensor in blinded mode for three 10-day periods to collect comprehensive glucose data.
Standard of Care chest CT images will be drawn from the medical record, as available, from enrolled participants. FEV1 measurements prior to chest CT scans will be recorded to account for possible illness occurring at the time of scanning. Quantitative assessment of the pectoralis muscle area will be performed on the first single axial image above the aortic arch. Any additional standard of care chest CT's that are performed while the participant is enrolled in the study will also be collected and have a quantitative assessment of the pectoralis muscle performed.
DXA measurements for whole body, total hip and lumbar spine will be acquired using the Hologic DXA and standard positioning as noted in the DXA Manual of Operations. DXA will be used to estimate total and regional body composition, which will include body fat and lean body mass. This will be used as the gold standard from which to validate BIA and MAMC.
A minimum of 50 individuals will be enrolled. At each study visit, participants will undergo ultrasound muscle measurements (cross-sectional area and muscle thickness) of the biceps and quadriceps on each (left and right) side of the body (4 total areas). These measurements will be obtained in triplicate for each patient.
Screening tool for identifying households at risk of food insecurity and poor health outcomes linked to food insecurity with 3-items over the last 12 months.
Chronic Respiratory Infection Symptom Score (CRISS) is an 8-item respiratory symptom questionnaire covering the last 24-hours.
Spirometry will be performed in accordance with the current American Thoracic Society recommendations for the performance and interpretation of tests.
Single question over the last 3 months/90 days about cannabis use for GI problems and appetite. The clinical sites will not see the responses to this question. It will be completed by the participant online either during the study visit or at home.
Assessment of prior 12-month management of cystic fibrosis, including treatments, medication intake and hospitalizations. This questionnaire will only be completed at 24- and 36- month visits.
Assessment of prior 12-month nutritional intake being completed at Baseline (no later than 6-month visit) and 12-month visit.
Eligibility Criteria
The study population will include adults 18 and older with a confirmed diagnostic of cystic fibrosis, identified genotypes (when available), no prior solid organ transplant, and not pregnant or planning on becoming pregnant during the 1st year of the study. Participants receiving a lung transplantation while enrolled in the study will not need to be withdrawn.
You may qualify if:
- Cohort 1: Participants are eligible if their percentage of predicated forced expiratory volume in 1 second (ppFEV1) is \<70% during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation)
- Cohort 2: Participants are eligible if their percentage of predicted forced expiratory volume in 1 second (ppFEV1) is 70% or greater during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
- Both cohorts match by age, gender, race and CFTR genotype severity.
You may not qualify if:
- No prior solid organ transplantation
- No initiation of an investigation drug within 28 days prior to and including Baseline Visit.
- No initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston, CFTR modulator, etc.) within 28 days prior to and including Baseline visit.
- 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 Baseline visit.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
University of Arizona
Tucson, Arizona, 85724, United States
University of Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas, 72205, United States
Emory
Atlanta, Georgia, 30324, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Kentucky
Lexington, Kentucky, 40508, United States
Tulane University
New Orleans, Louisiana, 70112, United States
John Hopkins University
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital (MGH)
Boston, Massachusetts, 02114, United States
Boston Children's Hospital and Brigham and Women's CF Center
Boston, Massachusetts, 02120, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Washington University School of Medicine (St. Louis)
St Louis, Missouri, 63110, United States
Rutgers Health
New Brunswick, New Jersey, 08901, United States
New York Medical College (NYMC)
Hawthorne, New York, 10532, United States
Northwell LIJ Adult Cystic Fibrosis Center
New Hyde Park, New York, 11040, United States
University of Cincinnati
Cincinnati, Ohio, 45220, United States
University Hospitals
Cleveland, Ohio, 44106, United States
University of Oklahoma Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15224, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Baylor University
Houston, Texas, 77030, United States
University of Virginia Cystic Fibrosis Center
Charlottesville, Virginia, 22908, United States
Biospecimen
Serum, plasma, urine and stool samples will be collected.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Stein
Northwestern University
- PRINCIPAL INVESTIGATOR
Jessica Alvarez
Emory University
- PRINCIPAL INVESTIGATOR
Melissa Putman
Massachusetts General Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2022
First Posted
December 6, 2022
Study Start
April 20, 2023
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
March 13, 2026
Record last verified: 2026-03