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A Comparison of Clinical Parameters in With and Without Abnormal Glucose Tolerance.

A Comparison of Pulmonary Function, Functional Capacity, Muscle Strength, Physical Activity, Physical Fitness and Activities of Daily Living in Cystic Fibrosis Patient's With and Without Abnormal Glucose Tolerance.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04503408
Enrollment
40
Registered
2020-08-07
Start date
2019-09-13
Completion date
2020-03-11
Last updated
2020-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis, Cystic Fibrosis-related Diabetes, Diabetes Mellitus

Keywords

Glucose, Cystic fibrosis, Muscle strength, Physical fitness

Brief summary

Cystic fibrosis (CF) is autosomal recessive, genetic disorder cause of cystic fibrosis transmembrane regulatory (CFTR) gene mutation. CF often is observed in caucasian population. CFTR protein in cell apical membrane is canal responsible of transport sodium and clorid ions. Impaired sodium ion transport causes production viscous mucus. Disease include problems such as mucus, breathlessness and coughing. Blood glucose levels fluctuation are observed. This study aims comparison between lung function, functional capacity, muscle strength, physical activity, physical fitness and activities of daily living activities in cystic fibrosis with and without abnormal glucose tolerance

Detailed description

The study aimed that comparison of clinical parameters in children with and without abnormal glucose tolerance in Cystic fibrosis.

Interventions

None listed

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

1. Cystic fibrosis with impaired glucose tolerance or cystic fibrosis-related diabetes for Abnormal glucose tolerance group 2. Cooperation for tests 3. Indıviduals without an orthopedic or neurological problem and serious cardiac problems that effecting tests, 4. To volunteer for the study. For the control group 1. Cystic fibrosis with normal glucose tolerance 2. Cooperation for tests 3. Indıviduals without an orthopedic or neurological problem and serious cardiac problems that effecting tests, 4. To volunteer for the study.

Exclusion criteria

Patients having following disease 1. Acute pulmonary exacerbation 2. Acute or chronic respiratory failure 3. FEV₁ lower than %40 4. Cooperation problems, 5. Bronchopulmonary aspergillus and using steroid.

Design outcomes

Primary

MeasureTime frameDescription
Distance of 6 minute walk test28 weekDistance of 6 minute walk test assesing functional capacity made on flat corridor with speed is determined from participant. She/he walks during 6 minute on this corridor as quickly as possible.
Lung function28 weekLung function will be assesed for standardization procedure in Cystic fibrosis. Acceptible outcome will be recorded.
Respiratory muscle strength28 weekBoth inspiratory and expiratory muscle strength wil be evaluated at least three times in Cystic fibrosis. Mouth pressure device will be used for evaluate. The highest value for MIP and MEP will be recorded.
Quadriceps muscle strength28 weekQuadriceps muscle strength will be assessed least three times in children with cystic fibrosis. hand held dynamometer will be used for assessing quadriceps muscle strength. The highest value for each side will be recorded and used for analysis.
Handgrip28 weekHandgrip will be assessed in Cystic fibrosis using hand dynamometer (Jamar hand dynamometer). Assessing will be repeated three times end mean of three measurement will be calculated and used for analysis.
Physical activity levels28 weekPhysical activity will be evaluated with Bouchard physical activity record. This activity recorder is evaluated every 15 min in a day. Two weekday and one weekend day are recorded with made activity.
Physical fitness28 weekPhysical fitness is measured with Munich physical fitness test battery. This battery vertial jump, bouncing ball, flexibilty, climbing, throwing bag, step up test are included in battery. the battery evaluates such as strength, endurance, speed, flexibilty, coordination, power.
Distance of shuttle walk test28 weekDistance of shuttle walk test will be walked by children with cystic fibrosis. Shuttle walk test is made on floor with ten meters distance. Speed is determined according to signals from CD player.
Time of activities of daily living test28 weekActivities of daily living will be tested with the Glittre ADL test. This test includes five repeated cycles that includes sitting, walk, step up and changing place of object on bookshelf in test procedure. The total completion time of five cycles will be recorded and used for analysis

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026