Cystic FibrosisNCT05639556
Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF
An observational study of Cystic Fibrosis, run by Jaeb Center for Health Research at 23 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- BMI and lean mass index from DXA, Anthropometric Measurements and Hand-grip strength
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 300 participants
- Where
- 23 sitesUnited States
- Study dates
- 20 Apr 2023to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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 Participants receiving a lung transplantation while enrolled in the study will not need to be withdrawn.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Emory
Atlanta, Georgia, 30324
John Hopkins University
Baltimore, Maryland, 21287
Massachusetts General Hospital (MGH)
Boston, Massachusetts, 02114
Boston Children's Hospital and Brigham and Women's CF Center
Boston, Massachusetts, 02120
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia Cystic Fibrosis Center
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
University of Cincinnati
Cincinnati, Ohio, 45220
University Hospitals
Cleveland, Ohio, 44106
New York Medical College (NYMC)
Hawthorne, New York, 10532
Baylor University
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
University of Kentucky
Lexington, Kentucky, 40508
University of Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas, 72205
University of Minnesota
Minneapolis, Minnesota, 55455
Rutgers Health
New Brunswick, New Jersey, 08901
Northwell LIJ Adult Cystic Fibrosis Center
New Hyde Park, New York, 11040
Tulane University
New Orleans, Louisiana, 70112
University of Oklahoma Sciences Center
Oklahoma City, Oklahoma, 73104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15224
Oregon Health and Science University
Portland, Oregon, 97239
Washington University School of Medicine (St. Louis)
St Louis, Missouri, 63110
University of Arizona
Tucson, Arizona, 85724
About this study
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.
- Conditions
- Cystic Fibrosis
- Being tested
- BMI and lean mass index from DXA, Anthropometric Measurements, Hand-grip strength, Six-minute walk Test, Sit-to-Stand Test
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMI and lean mass index from DXADiagnostic test
Estimate and compare correlation between lean mass index from DXA and BMI
Anthropometric MeasurementsDiagnostic test
Skinfold will be assessed with calipers. Circumference will be measured with a tape measure.
Hand-grip strengthDiagnostic test
A small, handheld dynamometer will be used to measure grip strength, a measure of function, on each hand.
Six-minute walk TestDiagnostic test
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.
Sit-to-Stand TestDiagnostic test
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.
Short physical performance battery (SPPB)Diagnostic test
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).
BIA Sub-studyDiagnostic test
A minimum of 50 individuals will be enrolled. Body composition will be assessed at each study visit using study bioelectrical impendence analysis (BIA).
Accelerometry to assess physical activityDiagnostic test
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.
Gastrointestinal (GI) and nutrition questionnaires:Other
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).
Psychosocial questionnaire: PHQ-8Other
This is an 8-item scale that measures depressive symptoms over the past two weeks.
Psychosocial questionnaire: GAD-7Other
This is a 7-items scale that measures anxiety symptoms over the past two weeks, from not at all to nearly every day.
Psychosocial questionnaire: The Treatment Self-Regulation Questionnaire (TSRQ)Other
This is a 15-item scale that assesses the degree to which participants' motivation is autonomous or self-regulated.
Psychosocial questionnaire: CF Fatalism ScaleOther
The CF Fatalism Scale measures the belief in a lack of personal power or control over one's future and has 13 items.
Psychosocial questionnaire: Body Esteem Scale for Adolescents and Adults (BESAA)Other
The Body Esteem Scale for Adolescents and Adults (BESAA) is 23-item measurement of self-evaluations of one's body or appearance.
12-month QuestionnaireOther
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.
Oral glucose tolerance testing (OGTT)Other
For subjects without previously diagnosed CFRD, an OGTT will be performed at baseline and 12-months with samples analyzed at the central lab.
Continuous glucose monitoring (CGM)Device
Subjects will wear a Dexcom G6Pro sensor in blinded mode for three 10-day periods to collect comprehensive glucose data.
Chest CT scans (When available within the past 6 months in medical records)Diagnostic test
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.
Hologic Dual X-Ray Absorptiometry (DXA)Diagnostic test
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.
Ultrasound Sub-study of assessment of appendage muscles using ultrasoundDiagnostic test
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.
Psychosocial questionnaire: Hunger Vital Sign questionnaireDiagnostic test
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.
Respiratory symptom questionnaire: CRISSOther
Chronic Respiratory Infection Symptom Score (CRISS) is an 8-item respiratory symptom questionnaire covering the last 24-hours.
SpirometryDiagnostic test
Spirometry will be performed in accordance with the current American Thoracic Society recommendations for the performance and interpretation of tests.
Psychosocial questionnaire: Additional Health QuestionnaireOther
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.
CF Management QuestionnaireOther
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.
Food Frequency QuestionnaireOther
Assessment of prior 12-month nutritional intake being completed at Baseline (no later than 6-month visit) and 12-month visit.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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: Gastrointestinal (GI) and nutrition questionnaires:; Other: Psychosocial questionnaire: PHQ-8; Other: Psychosocial questionnaire: GAD-7; Other: Psychosocial questionnaire: The Treatment Self-Regulation Questionnaire (TSRQ); Other: Psychosocial questionnaire: CF Fatalism Scale; Other: Psychosocial questionnaire: Body Esteem Scale for Adolescents and Adults (BESAA); 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: Psychosocial questionnaire: Hunger Vital Sign questionnaire; Other: Respiratory symptom questionnaire: CRISS; Diagnostic Test: Spirometry; Other: Psychosocial questionnaire: Additional Health Questionnaire; Other: CF Management Questionnaire; Other: Food Frequency Questionnaire | |
| Cohort 2 | FEV1 ≥70% predicted during the 12 months prior to enrollment (>50% of measurements, eliminating periods of exacerbation). Receives: 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: Gastrointestinal (GI) and nutrition questionnaires:; Other: Psychosocial questionnaire: PHQ-8; Other: Psychosocial questionnaire: GAD-7; Other: Psychosocial questionnaire: The Treatment Self-Regulation Questionnaire (TSRQ); Other: Psychosocial questionnaire: CF Fatalism Scale; Other: Psychosocial questionnaire: Body Esteem Scale for Adolescents and Adults (BESAA); 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: Psychosocial questionnaire: Hunger Vital Sign questionnaire; Other: Respiratory symptom questionnaire: CRISS; Diagnostic Test: Spirometry; Other: Psychosocial questionnaire: Additional Health Questionnaire; Other: CF Management Questionnaire; Other: Food Frequency Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between DXA lean mass index and BMI
Estimate and compare correlation between lean mass index from DXA (kg/m2) and BMI (kg/m2)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline and 1 year
Secondary outcomes (22)
Characterize lean mass index from DXA cross-sectionally and longitudinally
Characterize lean mass index from DXA cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
Measured: Baseline and 1 year
Characterize BMI cross-sectionally and longitudinally
Characterize lean mass index from BMI cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
Measured: Baseline and 1 year
Characterize mid-arm measurement circumference cross-sectionally and longitudinally
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
Measured: Baseline and 1 year
Characterize hand-grip strength cross-sectionally and longitudinally
Characterize hand-grip strength cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
Measured: Baseline and 1 year
Characterize 1 minute sit-to-stand repetitions cross-sectionally and longitudinally
Characterize the 1 minute sit-to-stand repetitions cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
Measured: Baseline and 1 year
Characterize mid-arm 6-minute walk test distance traveled cross-sectionally and longitudinally
Characterize the 6-minute walk test distance traveled cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
Measured: Baseline and 1 year
Characterize the Short Physical Performance Battery frailty score cross-sectionally and longitudinally
Characterize the Short Physical Performance Battery frailty score cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
Measured: Baseline and 1 year
Compare lean mass index from DXA between participants with FEV1 <70% to matched participants with FEV1 ≥70%
Compare lean mass index from DXA between participants with FEV1 <70% to matched participants with FEV1 ≥70%.
Measured: Baseline and 1 year
Compare BMI between participants with FEV1 <70% to matched participants with FEV1 ≥70%
Compare BMI between participants with FEV1 <70% to matched participants with FEV1 ≥70%.
Measured: Baseline and 1 year
Compare lean mass index from mid-arm muscle circumference between participants with FEV1 <70% to matched participants with FEV1 ≥70%
Compare lean mass index from mid-arm muscle circumference between participants with FEV1 <70% to matched participants with FEV1 ≥70%.
Measured: Baseline and 1 year
Compare hand-grip strength between participants with FEV1 <70% to matched participants with FEV1 ≥70%
Compare hand-grip strength between participants with FEV1 <70% to matched participants with FEV1 ≥70%.
Measured: Baseline and 1 year
Compare the 1-minute sit-to-stand repetitions between participants with FEV1 <70% to matched participants with FEV1 ≥70%
Compare the 1-minute sit-to-stand repetitions between participants with FEV1 <70% to matched participants with FEV1 ≥70%.
Measured: Baseline and 1 year
Compare the 6-minute walk test distance between participants with FEV1 <70% to matched participants with FEV1 ≥70%
Compare the 6-minute walk test distance between participants with FEV1 <70% to matched participants with FEV1 ≥70%.
Measured: Baseline and 1 year
Compare the Short Physical Performance Battery frailty score between participants with FEV1 <70% to matched participants with FEV1 ≥70%
Compare the Short Physical Performance Battery frailty score between participants with FEV1 <70% to matched participants with FEV1 ≥70%.
Measured: Baseline and 1 year
Evaluate mean glucose in participants with FEV1 <70% and matched participants with FEV1 ≥70%
Evaluate mean glucose from continuous glucose measurement data in participants with FEV1 <70% and matched participants with FEV1 ≥70%
Measured: Baseline and 1 year
Evaluate % time above 140 mg/dL in participants with FEV1 <70% and matched participants with FEV1 ≥70%
Evaluate % time above 140 mg/dL from continuous glucose measurement data in participants with FEV1 <70% and matched participants with FEV1 ≥70%
Measured: Baseline and 1 year
Evaluate % time above 180 mg/dL in participants with FEV1 <70% and matched participants with FEV1 ≥70%
Evaluate % time above 180 mg/dL from continuous glucose measurement data in participants with FEV1 <70% and matched participants with FEV1 ≥70%
Measured: Baseline and 1 year
Evaluate peak glucose in participants with FEV1 <70% and matched participants with FEV1 ≥70%
Evaluate peak glucose from continuous glucose measurement data in participants with FEV1 <70% and matched participants with FEV1 ≥70%
Measured: Baseline and 1 year
Evaluate % time below 70 mg/dL in participants with FEV1 <70% and matched participants with FEV1 ≥70%
Evaluate % time below 70 mg/dL from continuous glucose measurement data in participants with FEV1 <70% and matched participants with FEV1 ≥70%
Measured: Baseline and 1 year
Evaluate % time below 54 mg/dL in participants with FEV1 <70% and matched participants with FEV1 ≥70%
Evaluate % time below 54 mg/dL from continuous glucose measurement data in participants with FEV1 <70% and matched participants with FEV1 ≥70%
Measured: Baseline and 1 year
Evaluate the standard deviation in CGM glucose data in participants with FEV1 <70% and matched participants with FEV1 ≥70%
Evaluate the standard deviation in CGM glucose data in participants with FEV1 <70% and matched participants with FEV1 ≥70%
Measured: Baseline and 1 year
Evaluate the coefficient of variation in CGM glucose data in participants with FEV1 <70% and matched participants with FEV1 ≥70% participants
Evaluate the coefficient of variation in CGM glucose data in participants with FEV1 <70% and matched participants with FEV1 ≥70% participants
Measured: Baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start20 Apr 2023
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Stein, Principal investigator, Northwestern UniversityJessica Alvarez, Principal investigator, Emory UniversityMelissa Putman, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639556
- Sponsor's protocol ID
- STRONG-CF
- Status last verified
- Mar 2026
- First submitted
- 14 Nov 2022
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF
- ClinicalTrials.gov ID
- NCT05639556
- Acronym / sponsor ID
- STRONG-CF
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | 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: Gastrointestinal (GI) and nutrition questionnaires:, Other: Psychosocial questionnaire: PHQ-8, Other: Psychosocial questionnaire: GAD-7, Other: Psychosocial questionnaire: The Treatment Self-Regulation Questionnaire (TSRQ), Other: Psychosocial questionnaire: CF Fatalism Scale, Other: Psychosocial questionnaire: Body Esteem Scale for Adolescents and Adults (BESAA), 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: Psychosocial questionnaire: Hunger Vital Sign questionnaire, Other: Respiratory symptom questionnaire: CRISS, Diagnostic Test: Spirometry, Other: Psychosocial questionnaire: Additional Health Questionnaire, Other: CF Management Questionnaire, Other: Food Frequency QuestionnaireForced 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 | – | 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: Gastrointestinal (GI) and nutrition questionnaires:, Other: Psychosocial questionnaire: PHQ-8, Other: Psychosocial questionnaire: GAD-7, Other: Psychosocial questionnaire: The Treatment Self-Regulation Questionnaire (TSRQ), Other: Psychosocial questionnaire: CF Fatalism Scale, Other: Psychosocial questionnaire: Body Esteem Scale for Adolescents and Adults (BESAA), 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: Psychosocial questionnaire: Hunger Vital Sign questionnaire, Other: Respiratory symptom questionnaire: CRISS, Diagnostic Test: Spirometry, Other: Psychosocial questionnaire: Additional Health Questionnaire, Other: CF Management Questionnaire, Other: Food Frequency QuestionnaireFEV1 ≥70% predicted during the 12 months prior to enrollment (>50% of measurements, eliminating periods of exacerbation). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMI and lean mass index from DXAEstimate and compare correlation between lean mass index from DXA and BMI | Diagnostic test | Cohort 1, Cohort 2 |
| Anthropometric MeasurementsSkinfold will be assessed with calipers. Circumference will be measured with a tape measure. | Diagnostic test | Cohort 1, Cohort 2 |
| Hand-grip strengthA small, handheld dynamometer will be used to measure grip strength, a measure of function, on each hand. | Diagnostic test | Cohort 1, Cohort 2 |
| Six-minute walk TestThis 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. | Diagnostic test | Cohort 1, Cohort 2 |
| Sit-to-Stand TestThis 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. | Diagnostic test | Cohort 1, Cohort 2 |
| Short physical performance battery (SPPB)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). | Diagnostic test | Cohort 1, Cohort 2 |
| BIA Sub-studyA minimum of 50 individuals will be enrolled. Body composition will be assessed at each study visit using study bioelectrical impendence analysis (BIA). | Diagnostic test | Cohort 1, Cohort 2 |
| Accelerometry to assess physical activityParticipants 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. | Diagnostic test | Cohort 1, Cohort 2 |
| Gastrointestinal (GI) and nutrition questionnaires: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). | Other | Cohort 1, Cohort 2 |
| Psychosocial questionnaire: PHQ-8This is an 8-item scale that measures depressive symptoms over the past two weeks. | Other | Cohort 1, Cohort 2 |
| Psychosocial questionnaire: GAD-7This is a 7-items scale that measures anxiety symptoms over the past two weeks, from not at all to nearly every day. | Other | Cohort 1, Cohort 2 |
| Psychosocial questionnaire: The Treatment Self-Regulation Questionnaire (TSRQ)This is a 15-item scale that assesses the degree to which participants' motivation is autonomous or self-regulated. | Other | Cohort 1, Cohort 2 |
| Psychosocial questionnaire: CF Fatalism ScaleThe CF Fatalism Scale measures the belief in a lack of personal power or control over one's future and has 13 items. | Other | Cohort 1, Cohort 2 |
| Psychosocial questionnaire: Body Esteem Scale for Adolescents and Adults (BESAA)The Body Esteem Scale for Adolescents and Adults (BESAA) is 23-item measurement of self-evaluations of one's body or appearance. | Other | Cohort 1, Cohort 2 |
| 12-month QuestionnaireA 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. | Other | Cohort 1, Cohort 2 |
| Oral glucose tolerance testing (OGTT)For subjects without previously diagnosed CFRD, an OGTT will be performed at baseline and 12-months with samples analyzed at the central lab. | Other | Cohort 1, Cohort 2 |
| Continuous glucose monitoring (CGM)Subjects will wear a Dexcom G6Pro sensor in blinded mode for three 10-day periods to collect comprehensive glucose data. | Device | Cohort 1, Cohort 2 |
| Chest CT scans (When available within the past 6 months in medical records)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. | Diagnostic test | Cohort 1, Cohort 2 |
| Hologic Dual X-Ray Absorptiometry (DXA)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. | Diagnostic test | Cohort 1, Cohort 2 |
| Ultrasound Sub-study of assessment of appendage muscles using ultrasoundA 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. | Diagnostic test | Cohort 1, Cohort 2 |
| Psychosocial questionnaire: Hunger Vital Sign questionnaireScreening 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. | Diagnostic test | Cohort 1, Cohort 2 |
| Respiratory symptom questionnaire: CRISSChronic Respiratory Infection Symptom Score (CRISS) is an 8-item respiratory symptom questionnaire covering the last 24-hours. | Other | Cohort 1, Cohort 2 |
| SpirometrySpirometry will be performed in accordance with the current American Thoracic Society recommendations for the performance and interpretation of tests. | Diagnostic test | Cohort 1, Cohort 2 |
| Psychosocial questionnaire: Additional Health QuestionnaireSingle 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. | Other | Cohort 1, Cohort 2 |
| CF Management QuestionnaireAssessment 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. | Other | Cohort 1, Cohort 2 |
| Food Frequency QuestionnaireAssessment of prior 12-month nutritional intake being completed at Baseline (no later than 6-month visit) and 12-month visit. | Other | Cohort 1, Cohort 2 |
Primary outcome
Correlation between DXA lean mass index and BMI
Time frame: 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
Time frame: 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 hand-grip strength
Time frame: 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 the 6-minute walk distance traveled
Time frame: 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
Time frame: 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 Short Physical Performance Battery frailty score
Time frame: 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)
22 secondary outcomes
Characterize lean mass index from DXA cross-sectionally and longitudinally
Time frame: Baseline and 1 year
Characterize BMI cross-sectionally and longitudinally
Time frame: Baseline and 1 year
Characterize mid-arm measurement circumference cross-sectionally and longitudinally
Time frame: Baseline and 1 year
Characterize hand-grip strength cross-sectionally and longitudinally
Time frame: Baseline and 1 year
Characterize 1 minute sit-to-stand repetitions cross-sectionally and longitudinally
Time frame: Baseline and 1 year
Characterize mid-arm 6-minute walk test distance traveled cross-sectionally and longitudinally
Time frame: Baseline and 1 year
Characterize the Short Physical Performance Battery frailty score cross-sectionally and longitudinally
Time frame: Baseline and 1 year
Compare lean mass index from DXA between participants with FEV1 <70% to matched participants with FEV1 ≥70%
Time frame: Baseline and 1 year
Compare BMI between participants with FEV1 <70% to matched participants with FEV1 ≥70%
Time frame: Baseline and 1 year
Compare lean mass index from mid-arm muscle circumference between participants with FEV1 <70% to matched participants with FEV1 ≥70%
Time frame: Baseline and 1 year
Compare hand-grip strength between participants with FEV1 <70% to matched participants with FEV1 ≥70%
Time frame: Baseline and 1 year
Compare the 1-minute sit-to-stand repetitions between participants with FEV1 <70% to matched participants with FEV1 ≥70%
Time frame: Baseline and 1 year
Compare the 6-minute walk test distance between participants with FEV1 <70% to matched participants with FEV1 ≥70%
Time frame: Baseline and 1 year
Compare the Short Physical Performance Battery frailty score between participants with FEV1 <70% to matched participants with FEV1 ≥70%
Time frame: Baseline and 1 year
Evaluate mean glucose in participants with FEV1 <70% and matched participants with FEV1 ≥70%
Time frame: Baseline and 1 year
Evaluate % time above 140 mg/dL in participants with FEV1 <70% and matched participants with FEV1 ≥70%
Time frame: Baseline and 1 year
Evaluate % time above 180 mg/dL in participants with FEV1 <70% and matched participants with FEV1 ≥70%
Time frame: Baseline and 1 year
Evaluate peak glucose in participants with FEV1 <70% and matched participants with FEV1 ≥70%
Time frame: Baseline and 1 year
Evaluate % time below 70 mg/dL in participants with FEV1 <70% and matched participants with FEV1 ≥70%
Time frame: Baseline and 1 year
Evaluate % time below 54 mg/dL in participants with FEV1 <70% and matched participants with FEV1 ≥70%
Time frame: Baseline and 1 year
Evaluate the standard deviation in CGM glucose data in participants with FEV1 <70% and matched participants with FEV1 ≥70%
Time frame: Baseline and 1 year
Evaluate the coefficient of variation in CGM glucose data in participants with FEV1 <70% and matched participants with FEV1 ≥70% participants
Time frame: Baseline and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Stein principal investigator
Northwestern University
Jessica Alvarez principal investigator
Emory University
Melissa Putman principal investigator
Massachusetts General Hospital
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Jaeb Center for Health Research at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between DXA lean mass index and BMI (time frame: Baseline and 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.