Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF
Status
Enrolling
Conditions
Cystic Fibrosis
Treatments
Other: Psychosocial questionnaire: The Treatment Self-Regulation Questionnaire (TSRQ)
Other: Psychosocial questionnaire: Additional Health Questionnaire
Diagnostic Test: Hologic Dual X-Ray Absorptiometry (DXA)
Diagnostic Test: Psychosocial questionnaire: Hunger Vital Sign questionnaire
Device: Continuous glucose monitoring (CGM)
Diagnostic Test: Chest CT scans (When available within the past 6 months in medical records)
Diagnostic Test: Short physical performance battery (SPPB)
Other: Oral glucose tolerance testing (OGTT)
Diagnostic Test: Sit-to-Stand Test
Other: Psychosocial questionnaire: GAD-7
Diagnostic Test: BIA Sub-study
Other: CF Management Questionnaire
Other: Food Frequency Questionnaire
Other: Respiratory symptom questionnaire: CRISS
Diagnostic Test: BMI and lean mass index from DXA
Diagnostic Test: Accelerometry to assess physical activity
Other: 12-month Questionnaire
Diagnostic Test: Spirometry
Other: Psychosocial questionnaire: PHQ-8
Other: Psychosocial questionnaire: CF Fatalism Scale
Other: Psychosocial questionnaire: Body Esteem Scale for Adolescents and Adults (BESAA)
Diagnostic Test: Anthropometric Measurements
Diagnostic Test: Ultrasound Sub-study of assessment of appendage muscles using ultrasound
Other: Gastrointestinal (GI) and nutrition questionnaires:
Diagnostic Test: Six-minute walk Test
Diagnostic Test: Hand-grip strength
Details and patient eligibility
About
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.
Enrollment
300 estimated patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- 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.
Exclusion criteria
- 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 design
300 participants in 2 patient groups
Cohort 1
Description:
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.
Treatment:
Diagnostic Test: Hand-grip strength
Diagnostic Test: Six-minute walk Test
Diagnostic Test: Ultrasound Sub-study of assessment of appendage muscles using ultrasound
Other: Gastrointestinal (GI) and nutrition questionnaires:
Diagnostic Test: Anthropometric Measurements
Other: Psychosocial questionnaire: Body Esteem Scale for Adolescents and Adults (BESAA)
Other: Psychosocial questionnaire: CF Fatalism Scale
Other: Psychosocial questionnaire: PHQ-8
Diagnostic Test: Spirometry
Other: 12-month Questionnaire
Diagnostic Test: Accelerometry to assess physical activity
Diagnostic Test: BMI and lean mass index from DXA
Other: Respiratory symptom questionnaire: CRISS
Other: Food Frequency Questionnaire
Other: CF Management Questionnaire
Other: Psychosocial questionnaire: GAD-7
Diagnostic Test: BIA Sub-study
Diagnostic Test: Sit-to-Stand Test
Other: Oral glucose tolerance testing (OGTT)
Diagnostic Test: Chest CT scans (When available within the past 6 months in medical records)
Device: Continuous glucose monitoring (CGM)
Diagnostic Test: Short physical performance battery (SPPB)
Diagnostic Test: Psychosocial questionnaire: Hunger Vital Sign questionnaire
Diagnostic Test: Hologic Dual X-Ray Absorptiometry (DXA)
Other: Psychosocial questionnaire: Additional Health Questionnaire
Other: Psychosocial questionnaire: The Treatment Self-Regulation Questionnaire (TSRQ)
Cohort 2
Description:
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
Treatment:
Diagnostic Test: Hand-grip strength
Diagnostic Test: Six-minute walk Test
Diagnostic Test: Ultrasound Sub-study of assessment of appendage muscles using ultrasound
Other: Gastrointestinal (GI) and nutrition questionnaires:
Diagnostic Test: Anthropometric Measurements
Other: Psychosocial questionnaire: Body Esteem Scale for Adolescents and Adults (BESAA)
Other: Psychosocial questionnaire: CF Fatalism Scale
Other: Psychosocial questionnaire: PHQ-8
Diagnostic Test: Spirometry
Other: 12-month Questionnaire
Diagnostic Test: Accelerometry to assess physical activity
Diagnostic Test: BMI and lean mass index from DXA
Other: Respiratory symptom questionnaire: CRISS
Other: Food Frequency Questionnaire
Other: CF Management Questionnaire
Other: Psychosocial questionnaire: GAD-7
Diagnostic Test: BIA Sub-study
Diagnostic Test: Sit-to-Stand Test
Other: Oral glucose tolerance testing (OGTT)
Diagnostic Test: Chest CT scans (When available within the past 6 months in medical records)
Device: Continuous glucose monitoring (CGM)
Diagnostic Test: Short physical performance battery (SPPB)
Diagnostic Test: Psychosocial questionnaire: Hunger Vital Sign questionnaire
Diagnostic Test: Hologic Dual X-Ray Absorptiometry (DXA)
Other: Psychosocial questionnaire: Additional Health Questionnaire
Other: Psychosocial questionnaire: The Treatment Self-Regulation Questionnaire (TSRQ)
Trial contacts and locations
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Central trial contact
Judy Sibayan
Data sourced from clinicaltrials.gov
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