Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF
概览
- 阶段
- 不适用
- 干预措施
- BMI and lean mass index from DXA
- 疾病 / 适应症
- Cystic Fibrosis
- 发起方
- Jaeb Center for Health Research
- 入组人数
- 300
- 试验地点
- 47
- 主要终点
- Correlation between DXA lean mass index and BMI
- 状态
- 进行中（未招募）
- 最后更新
- 上个月
概览
简要总结
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.
研究者
入排标准
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: BMI and lean mass index from DXA
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.
干预措施: Anthropometric Measurements
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.
干预措施: Hand-grip strength
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.
干预措施: Six-minute walk Test
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.
干预措施: Sit-to-Stand Test
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.
干预措施: Short physical performance battery (SPPB)
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.
干预措施: BIA Sub-study
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.
干预措施: Accelerometry to assess physical activity
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.
干预措施: Gastrointestinal (GI) and nutrition questionnaires:
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.
干预措施: Psychosocial questionnaire: PHQ-8
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.
干预措施: Psychosocial questionnaire: GAD-7
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.
干预措施: Psychosocial questionnaire: The Treatment Self-Regulation Questionnaire (TSRQ)
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.
干预措施: Psychosocial questionnaire: CF Fatalism Scale
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.
干预措施: Psychosocial questionnaire: Body Esteem Scale for Adolescents and Adults (BESAA)
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.
干预措施: 12-month Questionnaire
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.
干预措施: Oral glucose tolerance testing (OGTT)
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.
干预措施: Continuous glucose monitoring (CGM)
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.
干预措施: Chest CT scans (When available within the past 6 months in medical records)
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.
干预措施: Hologic Dual X-Ray Absorptiometry (DXA)
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.
干预措施: Ultrasound Sub-study of assessment of appendage muscles using ultrasound
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.
干预措施: Psychosocial questionnaire: Hunger Vital Sign questionnaire
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.
干预措施: Respiratory symptom questionnaire: CRISS
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.
干预措施: Spirometry
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.
干预措施: Psychosocial questionnaire: Additional Health Questionnaire
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.
干预措施: CF Management Questionnaire
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.
干预措施: Food Frequency Questionnaire
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: BMI and lean mass index from DXA
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: Anthropometric Measurements
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: Hand-grip strength
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: Six-minute walk Test
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: Sit-to-Stand Test
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: Short physical performance battery (SPPB)
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: BIA Sub-study
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: Accelerometry to assess physical activity
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: Gastrointestinal (GI) and nutrition questionnaires:
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: Psychosocial questionnaire: PHQ-8
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: Psychosocial questionnaire: GAD-7
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: Psychosocial questionnaire: The Treatment Self-Regulation Questionnaire (TSRQ)
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: Psychosocial questionnaire: CF Fatalism Scale
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: Psychosocial questionnaire: Body Esteem Scale for Adolescents and Adults (BESAA)
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: 12-month Questionnaire
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: Oral glucose tolerance testing (OGTT)
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: Continuous glucose monitoring (CGM)
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: Chest CT scans (When available within the past 6 months in medical records)
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: Spirometry
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: Hologic Dual X-Ray Absorptiometry (DXA)
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: Ultrasound Sub-study of assessment of appendage muscles using ultrasound
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: Psychosocial questionnaire: Hunger Vital Sign questionnaire
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: Respiratory symptom questionnaire: CRISS
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: Psychosocial questionnaire: Additional Health Questionnaire
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: CF Management Questionnaire
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
干预措施: Food Frequency Questionnaire
结局指标
主要结局
Correlation between DXA lean mass index and BMI
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
次要结局
- 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)
- Characterize mid-arm 6-minute walk test distance traveled cross-sectionally and longitudinally(Baseline and 1 year)
- Characterize the Short Physical Performance Battery frailty score cross-sectionally and longitudinally(Baseline and 1 year)
- Compare lean mass index from DXA between participants with FEV1 <70% to matched participants with FEV1 ≥70%(Baseline and 1 year)
- Compare BMI between participants with FEV1 <70% to matched participants with FEV1 ≥70%(Baseline and 1 year)
- Compare lean mass index from mid-arm muscle circumference between participants with FEV1 <70% to matched participants with FEV1 ≥70%(Baseline and 1 year)
- Compare hand-grip strength between participants with FEV1 <70% to matched participants with FEV1 ≥70%(Baseline and 1 year)
- Compare the 1-minute sit-to-stand repetitions between participants with FEV1 <70% to matched participants with FEV1 ≥70%(Baseline and 1 year)
- Compare the 6-minute walk test distance between participants with FEV1 <70% to matched participants with FEV1 ≥70%(Baseline and 1 year)
- Compare the Short Physical Performance Battery frailty score between participants with FEV1 <70% to matched participants with FEV1 ≥70%(Baseline and 1 year)
- Evaluate mean glucose in participants with FEV1 <70% and matched participants with FEV1 ≥70%(Baseline and 1 year)
- Evaluate % time above 140 mg/dL in participants with FEV1 <70% and matched participants with FEV1 ≥70%(Baseline and 1 year)
- Evaluate % time above 180 mg/dL in participants with FEV1 <70% and matched participants with FEV1 ≥70%(Baseline and 1 year)
- Evaluate peak glucose in participants with FEV1 <70% and matched participants with FEV1 ≥70%(Baseline and 1 year)
- Evaluate % time below 70 mg/dL in participants with FEV1 <70% and matched participants with FEV1 ≥70%(Baseline and 1 year)
- Evaluate % time below 54 mg/dL in participants with FEV1 <70% and matched participants with FEV1 ≥70%(Baseline and 1 year)
- Evaluate the standard deviation in CGM glucose data in participants with FEV1 <70% and matched participants with FEV1 ≥70%(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(Baseline and 1 year)