Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF
NCT ID: NCT05639556
Last Updated: 2025-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2023-04-20
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
BMI and lean mass index from DXA
Estimate and compare correlation between lean mass index from DXA and BMI
Anthropometric Measurements
Skinfold will be assessed with calipers. Circumference will be measured with a tape measure.
Hand-grip strength
A small, handheld dynamometer will be used to measure grip strength, a measure of function, on each hand.
Six-minute walk 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 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)
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-study
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 activity
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:
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-8
This is an 8-item scale that measures depressive symptoms over the past two weeks.
Psychosocial questionnaire: GAD-7
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)
This is a 15-item scale that assesses the degree to which participants' motivation is autonomous or self-regulated.
Psychosocial questionnaire: CF Fatalism Scale
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)
The Body Esteem Scale for Adolescents and Adults (BESAA) is 23-item measurement of self-evaluations of one's body or appearance.
12-month Questionnaire
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)
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)
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)
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)
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 ultrasound
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 questionnaire
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: CRISS
Chronic Respiratory Infection Symptom Score (CRISS) is an 8-item respiratory symptom questionnaire covering the last 24-hours.
Spirometry
Spirometry will be performed in accordance with the current American Thoracic Society recommendations for the performance and interpretation of tests.
Psychosocial questionnaire: Additional Health Questionnaire
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 Questionnaire
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 Questionnaire
Assessment of prior 12-month nutritional intake being completed at Baseline (no later than 6-month visit) and 12-month visit.
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
BMI and lean mass index from DXA
Estimate and compare correlation between lean mass index from DXA and BMI
Anthropometric Measurements
Skinfold will be assessed with calipers. Circumference will be measured with a tape measure.
Hand-grip strength
A small, handheld dynamometer will be used to measure grip strength, a measure of function, on each hand.
Six-minute walk 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 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)
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-study
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 activity
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:
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-8
This is an 8-item scale that measures depressive symptoms over the past two weeks.
Psychosocial questionnaire: GAD-7
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)
This is a 15-item scale that assesses the degree to which participants' motivation is autonomous or self-regulated.
Psychosocial questionnaire: CF Fatalism Scale
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)
The Body Esteem Scale for Adolescents and Adults (BESAA) is 23-item measurement of self-evaluations of one's body or appearance.
12-month Questionnaire
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)
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)
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)
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)
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 ultrasound
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 questionnaire
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: CRISS
Chronic Respiratory Infection Symptom Score (CRISS) is an 8-item respiratory symptom questionnaire covering the last 24-hours.
Spirometry
Spirometry will be performed in accordance with the current American Thoracic Society recommendations for the performance and interpretation of tests.
Psychosocial questionnaire: Additional Health Questionnaire
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 Questionnaire
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 Questionnaire
Assessment of prior 12-month nutritional intake being completed at Baseline (no later than 6-month visit) and 12-month visit.
Interventions
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BMI and lean mass index from DXA
Estimate and compare correlation between lean mass index from DXA and BMI
Anthropometric Measurements
Skinfold will be assessed with calipers. Circumference will be measured with a tape measure.
Hand-grip strength
A small, handheld dynamometer will be used to measure grip strength, a measure of function, on each hand.
Six-minute walk 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 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)
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-study
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 activity
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:
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-8
This is an 8-item scale that measures depressive symptoms over the past two weeks.
Psychosocial questionnaire: GAD-7
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)
This is a 15-item scale that assesses the degree to which participants' motivation is autonomous or self-regulated.
Psychosocial questionnaire: CF Fatalism Scale
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)
The Body Esteem Scale for Adolescents and Adults (BESAA) is 23-item measurement of self-evaluations of one's body or appearance.
12-month Questionnaire
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)
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)
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)
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)
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 ultrasound
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 questionnaire
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: CRISS
Chronic Respiratory Infection Symptom Score (CRISS) is an 8-item respiratory symptom questionnaire covering the last 24-hours.
Spirometry
Spirometry will be performed in accordance with the current American Thoracic Society recommendations for the performance and interpretation of tests.
Psychosocial questionnaire: Additional Health Questionnaire
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 Questionnaire
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 Questionnaire
Assessment of prior 12-month nutritional intake being completed at Baseline (no later than 6-month visit) and 12-month visit.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Jaeb Center for Health Research
OTHER
Responsible Party
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Principal Investigators
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Adam Stein
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Jessica Alvarez
Role: PRINCIPAL_INVESTIGATOR
Emory University
Melissa Putman
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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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
Emory
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Tulane University
New Orleans, Louisiana, United States
John Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital (MGH)
Boston, Massachusetts, United States
Boston Children's Hospital and Brigham and Women's CF Center
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University School of Medicine (St. Louis)
St Louis, Missouri, United States
Rutgers Health
New Brunswick, New Jersey, United States
New York Medical College (NYMC)
Hawthorne, New York, United States
Northwell LIJ Adult Cystic Fibrosis Center
New Hyde Park, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
University Hospitals
Cleveland, Ohio, United States
University of Oklahoma Sciences Center
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baylor University
Houston, Texas, United States
University of Virginia Cystic Fibrosis Center
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STRONG-CF
Identifier Type: -
Identifier Source: org_study_id
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